B. BRAUN PERIFIX CONTINUOUS EPIDURAL TRAY ADVERSE REPORTS
1.
BRAND NAME |
PERIFIX |
||||
TYPE OF DEVICE |
PERIFIX CONTINUOUS EPIDURAL TRAYS |
||||
BASELINE BRAND NAME |
PERIFIX |
||||
BASELINE GENERIC NAME |
CONTINUOUS EPIDURAL TRAY |
||||
BASELINE CATALOGUE NUMBER |
332229 |
||||
BASELINE MODEL NUMBER |
CE17TKCD |
||||
BASELINE DEVICE FAMILY |
CONTINUOUS EPIDURAL KIT |
||||
BASELINE DEVICE 510(K) NUMBER |
K840179 |
||||
BASELINE SHELF LIFE INFORMATION |
YES |
||||
IS BASELINE PMA NUMBER PROVIDED?</< TH> |
NO |
||||
BASELINE PREAMENDMENT? |
NO |
||||
TRANSITIONAL? |
NO |
||||
510(K) EXEMPT? |
NO |
||||
SHELF LIFE(Months) |
12 |
||||
DATE FIRST MARKETED |
02/24/1984 |
||||
MANUFACTURER (Section F) |
|
||||
MANUFACTURER (Section D) |
|
||||
MANUFACTURER CONTACT |
|
||||
DEVICE EVENT KEY |
422769 |
||||
MDR REPORT KEY |
433826 |
||||
EVENT KEY |
410502 |
||||
REPORT NUMBER |
2523676-2002-00071 |
||||
DEVICE SEQUENCE NUMBER |
1 |
||||
PRODUCT CODE |
CAZ |
||||
REPORT SOURCE |
MANUFACTURER |
||||
SOURCE TYPE |
USER FACILITY |
||||
REMEDIAL ACTION |
OTHER |
||||
EVENT TYPE |
INJURY |
||||
TYPE OF REPORT |
INITIAL |
||||
REPORT DATE |
12/09/2002 |
||||
1 DEVICE WAS INVOLVED IN THE EVENT |
|
||||
1 PATIENT WAS INVOLVED IN THE EVENT |
|
||||
DATE FDA RECEIVED |
12/16/2002 |
||||
IS THIS AN ADVERSE EVENT REPORT? |
YES |
||||
IS THIS A PRODUCT PROBLEM REPORT? |
NO |
||||
DEVICE OPERATOR |
HEALTH PROFESSIONAL |
||||
DEVICE MODEL NUMBER |
CE17TKCD |
||||
DEVICE CATALOGUE NUMBER |
332212 |
||||
WAS DEVICE AVAILABLE FOR EVALUATION? |
NO |
||||
IS THE REPORTER A HEALTH PROFESSIONAL? |
YES |
||||
WAS THE REPORT SENT TO FDA? |
NO |
||||
DISTRIBUTOR FACILITY AWARE DATE |
11/06/2002 |
||||
DEVICE AGE |
UNKNOWN |
||||
EVENT LOCATION |
HOSPITAL |
||||
DATE MANUFACTURER RECEIVED |
11/20/2002 |
||||
WAS DEVICE EVALUATED BY MANUFACTURER? |
DEVICE NOT RETURNED TO MANUFACTURER |
||||
IS THE DEVICE SINGLE USE? |
YES |
||||
TYPE OF DEVICE USAGE |
UNKNOWN |
||||
PATIENT OUTCOME |
OTHER |
ADVERSE EVENT OR PRODUCT PROBLEM DESCRIPTION |
REPORT DATE: 12/09/2002 MDR TEXT KEY: 1505753 Patient Sequence Number: 1 |
EVENT AS REPORTED BY THE USER FACILITY: "DURING REMOVAL OF EPIDURAL CATHETER, PORTION OF CATHETER STAYED IN PT. VERIFIED BY XRAY." |
|
ADDITIONAL MANUFACTURER NARRATIVE |
REPORT DATE: 12/09/2002 MDR TEXT KEY: 1505756 |
THE ACTUAL SAMPLE IS NOT AVAILABLE FOR THE MFR TO EVALUATE. WITHOUT THE SAMPLE, A COMPLETE EVALUATION COULD NOT BE PERFORMED. BASED ON THE INFO PROVIDED, NO SPECIFIC CONCLUSIONS CAN BE DRAWN. |
2.
BRAND NAME |
PERIFIX |
||||
TYPE OF DEVICE |
CONTINUOUS EPIDURAL KIT |
||||
BASELINE BRAND NAME |
PERIFIX |
||||
BASELINE GENERIC NAME |
CONTINUOUS EPIDURAL TRAY |
||||
BASELINE CATALOGUE NUMBER |
332086 |
||||
BASELINE MODEL NUMBER |
CE17TKF |
||||
BASELINE DEVICE FAMILY |
CONTINUOUS EPIDURAL KIT |
||||
BASELINE DEVICE 510(K) NUMBER |
K840179 |
||||
BASELINE SHELF LIFE INFORMATION |
YES |
||||
IS BASELINE PMA NUMBER PROVIDED?</< TH> |
NO |
||||
BASELINE PREAMENDMENT? |
NO |
||||
TRANSITIONAL? |
NO |
||||
510(K) EXEMPT? |
NO |
||||
SHELF LIFE(Months) |
12 |
||||
DATE FIRST MARKETED |
02/24/1984 |
||||
MANUFACTURER (Section F) |
|
||||
MANUFACTURER (Section D) |
|
||||
MANUFACTURER CONTACT |
|
||||
DEVICE EVENT KEY |
418446 |
||||
MDR REPORT KEY |
429440 |
||||
EVENT KEY |
406258 |
||||
REPORT NUMBER |
2523676-2002-00064 |
||||
DEVICE SEQUENCE NUMBER |
1 |
||||
PRODUCT CODE |
CAZ |
||||
REPORT SOURCE |
MANUFACTURER |
||||
SOURCE TYPE |
USER FACILITY |
||||
REMEDIAL ACTION |
OTHER |
||||
EVENT TYPE |
INJURY |
||||
TYPE OF REPORT |
INITIAL |
||||
REPORT DATE |
11/14/2002 |
||||
1 DEVICE WAS INVOLVED IN THE EVENT |
|
||||
1 PATIENT WAS INVOLVED IN THE EVENT |
|
||||
DATE FDA RECEIVED |
11/22/2002 |
||||
IS THIS AN ADVERSE EVENT REPORT? |
YES |
||||
IS THIS A PRODUCT PROBLEM REPORT? |
NO |
||||
DEVICE OPERATOR |
HEALTH PROFESSIONAL |
||||
DEVICE EXPIRATION DATE |
04/30/2003 |
||||
DEVICE MODEL NUMBER |
CE17TKF |
||||
DEVICE CATALOGUE NUMBER |
332086 |
||||
DEVICE LOT NUMBER |
60317566 |
||||
WAS DEVICE AVAILABLE FOR EVALUATION? |
YES |
||||
DATE RETURNED TO MANUFACTURER |
11/05/2002 |
||||
IS THE REPORTER A HEALTH PROFESSIONAL? |
YES |
||||
WAS THE REPORT SENT TO FDA? |
NO |
||||
DISTRIBUTOR FACILITY AWARE DATE |
10/16/2002 |
||||
DEVICE AGE |
UNKNOWN |
||||
EVENT LOCATION |
HOSPITAL |
||||
DATE MANUFACTURER RECEIVED |
10/24/2002 |
||||
WAS DEVICE EVALUATED BY MANUFACTURER? |
YES |
||||
IS THE DEVICE SINGLE USE? |
YES |
||||
TYPE OF DEVICE USAGE |
UNKNOWN |
||||
PATIENT OUTCOME |
OTHER |
ADVERSE EVENT OR PRODUCT PROBLEM DESCRIPTION |
REPORT DATE: 11/14/2002 MDR TEXT KEY: 1490435 Patient Sequence Number: 1 |
WHEN PLASTIC STYLET WAS REMOVED FROM EPIDURAL NEEDLE, THE TIP OF THE STYLET SHEARED OFF AND REMAINED IN PATIENT. |
|
ADDITIONAL MANUFACTURER NARRATIVE |
REPORT DATE: 11/14/2002 MDR TEXT KEY: 1490438 |
ONE USED TUOHY NEEDLE WAS RETURNED FOR EVVALUATION. THE STYLET APPEARS TO HAVE BEEN CUT TO THE APPROPRIATE LENGTH DURING ITS MANUFACTURING, HOWEVER, THE TIP OF THE STYLET'S BEVEL IS STRETCHED. BASED ON THE INFORMATION PROVIDED, NO SPECIFIC CONCLUSION CAN BE DRAWN. IF APPROPRIATE, A FOLLOW-UP REPORT WILL BE FILED WHEN ADDITIONAL INFORMATION PERTAINING TO THIS INCIDENT IS RECEIVED. |
3.
BRAND NAME |
PERIFIX |
||||
TYPE OF DEVICE |
CONTINUOUS EPIDURAL TRAY |
||||
BASELINE BRAND NAME |
PERIFIX |
||||
BASELINE GENERIC NAME |
CONTINUOUS EPIDURAL TRAY |
||||
BASELINE CATALOGUE NUMBER |
332229 |
||||
BASELINE MODEL NUMBER |
CE17TKCD |
||||
BASELINE DEVICE FAMILY |
CONTINUOUS EPIDURAL KIT |
||||
BASELINE DEVICE 510(K) NUMBER |
K840179 |
||||
BASELINE SHELF LIFE INFORMATION |
YES |
||||
IS BASELINE PMA NUMBER PROVIDED?</< TH> |
NO |
||||
BASELINE PREAMENDMENT? |
NO |
||||
TRANSITIONAL? |
NO |
||||
510(K) EXEMPT? |
NO |
||||
SHELF LIFE(Months) |
12 |
||||
DATE FIRST MARKETED |
02/24/1984 |
||||
MANUFACTURER (Section F) |
|
||||
MANUFACTURER (Section D) |
|
||||
MANUFACTURER CONTACT |
|
||||
DEVICE EVENT KEY |
412070 |
||||
MDR REPORT KEY |
423016 |
||||
EVENT KEY |
400109 |
||||
REPORT NUMBER |
2523676-2002-00060 |
||||
DEVICE SEQUENCE NUMBER |
1 |
||||
PRODUCT CODE |
CAZ |
||||
REPORT SOURCE |
MANUFACTURER |
||||
SOURCE TYPE |
USER FACILITY |
||||
REMEDIAL ACTION |
OTHER |
||||
EVENT TYPE |
INJURY |
||||
TYPE OF REPORT |
INITIAL |
||||
REPORT DATE |
10/07/2002 |
||||
1 DEVICE WAS INVOLVED IN THE EVENT |
|
||||
1 PATIENT WAS INVOLVED IN THE EVENT |
|
||||
DATE FDA RECEIVED |
10/15/2002 |
||||
IS THIS AN ADVERSE EVENT REPORT? |
YES |
||||
IS THIS A PRODUCT PROBLEM REPORT? |
NO |
||||
DEVICE OPERATOR |
HEALTH PROFESSIONAL |
||||
DEVICE EXPIRATION DATE |
03/30/2004 |
||||
DEVICE MODEL NUMBER |
CE17TKCD |
||||
DEVICE CATALOGUE NUMBER |
332229 |
||||
DEVICE LOT NUMBER |
60352183 |
||||
WAS DEVICE AVAILABLE FOR EVALUATION? |
NO |
||||
IS THE REPORTER A HEALTH PROFESSIONAL? |
YES |
||||
WAS THE REPORT SENT TO FDA? |
NO |
||||
DISTRIBUTOR FACILITY AWARE DATE |
09/11/2002 |
||||
DEVICE AGE |
UNKNOWN |
||||
EVENT LOCATION |
HOSPITAL |
||||
DATE MANUFACTURER RECEIVED |
09/13/2002 |
||||
WAS DEVICE EVALUATED BY MANUFACTURER? |
DEVICE NOT RETURNED TO MANUFACTURER |
||||
IS THE DEVICE SINGLE USE? |
YES |
||||
TYPE OF DEVICE USAGE |
UNKNOWN |
||||
PATIENT OUTCOME |
OTHER |
ADVERSE EVENT OR PRODUCT PROBLEM DESCRIPTION |
REPORT DATE: 10/07/2002 MDR TEXT KEY: 1468141 Patient Sequence Number: 1 |
DOCTOR MET RESISTANCE UPON REMOVING EPIDURAL CATHETER, CONTINUED TO PULL. UPON REMOVAL, FOUND TIP OF CATHETER MISSING (APPROX 1 CM). PT IN FOR BOWEL CANCER. UNABLE TO SEE CATHETER ON X-RAY. |
|
ADDITIONAL MANUFACTURER NARRATIVE |
REPORT DATE: 10/07/2002 MDR TEXT KEY: 1468144 |
THE ACTUAL SAMPLE IS NOT AVAILABLE FOR THE MFR'S EVAL. BASED ON THE INFO PROVIDED NO SPECIFIC CONCLUSIONS CAN BE DRAWN. HOWEVER, IT APPEARS THAT THE CATHETER BECAME LODGED IN BETWEEN TWO RIGID BODY STRUCTURES AND WAS PULLED BEYONG ITS DESIGN CAPABILITIES. |
4.
BRAND NAME |
PERIFIX |
||||
TYPE OF DEVICE |
CONTINUOUS EPIDURAL TRAY |
||||
BASELINE BRAND NAME |
PERIFIX |
||||
BASELINE GENERIC NAME |
CONTINUOUS EPIDURAL TRAY |
||||
BASELINE CATALOGUE NUMBER |
332220 |
||||
BASELINE MODEL NUMBER |
CE18TK |
||||
BASELINE DEVICE FAMILY |
CONTINUOUS EPIDURAL KIT |
||||
BASELINE DEVICE 510(K) NUMBER |
K840179 |
||||
BASELINE SHELF LIFE INFORMATION |
YES |
||||
IS BASELINE PMA NUMBER PROVIDED?</< TH> |
NO |
||||
BASELINE PREAMENDMENT? |
NO |
||||
TRANSITIONAL? |
NO |
||||
510(K) EXEMPT? |
NO |
||||
SHELF LIFE(Months) |
12 |
||||
DATE FIRST MARKETED |
02/24/1984 |
||||
MANUFACTURER (Section F) |
|
||||
MANUFACTURER (Section D) |
|
||||
MANUFACTURER CONTACT |
|
||||
DEVICE EVENT KEY |
403077 |
||||
MDR REPORT KEY |
414038 |
||||
EVENT KEY |
385346 |
||||
REPORT NUMBER |
2523676-2002-00050 |
||||
DEVICE SEQUENCE NUMBER |
1 |
||||
PRODUCT CODE |
CAZ |
||||
REPORT SOURCE |
MANUFACTURER |
||||
SOURCE TYPE |
USER FACILITY |
||||
REMEDIAL ACTION |
OTHER |
||||
EVENT TYPE |
INJURY |
||||
TYPE OF REPORT |
INITIAL |
||||
REPORT DATE |
08/27/2002 |
||||
1 DEVICE WAS INVOLVED IN THE EVENT |
|
||||
1 PATIENT WAS INVOLVED IN THE EVENT |
|
||||
DATE FDA RECEIVED |
08/30/2002 |
||||
IS THIS AN ADVERSE EVENT REPORT? |
YES |
||||
IS THIS A PRODUCT PROBLEM REPORT? |
NO |
||||
DEVICE MODEL NUMBER |
CE18TK |
||||
DEVICE CATALOGUE NUMBER |
332220 |
||||
WAS THE REPORT SENT TO FDA? |
NO |
||||
DEVICE AGE |
UNKNOWN |
||||
DATE MANUFACTURER RECEIVED |
07/31/2002 |
||||
WAS DEVICE EVALUATED BY MANUFACTURER? |
DEVICE NOT RETURNED TO MANUFACTURER |
||||
IS THE DEVICE SINGLE USE? |
YES |
||||
TYPE OF DEVICE USAGE |
UNKNOWN |
ADDITIONAL MANUFACTURER NARRATIVE |
REPORT DATE: 08/27/2002 MDR TEXT KEY: 1438206 |
THE ACTUAL SAMPLE WAS NOT MADE AVAILABLE TO THE MFR FOR EVALUATION. WITHOUT THE SAMPLE, A COMPLETE INVESTIGATION COULD NOT BE PERFORMED. BASED ON THE INFO PROVIDED, NO SPECIFIC CONCLUSIONS CAN BE DRAWN. |
5.
BRAND NAME |
PERIFIX |
|||
TYPE OF DEVICE |
CONTINUOUS EPIDURAL TRAY |
|||
BASELINE BRAND NAME |
PERIFIX |
|||
BASELINE GENERIC NAME |
CONTINUOUS EPIDURAL TRAY |
|||
BASELINE CATALOGUE NUMBER |
332220 |
|||
BASELINE MODEL NUMBER |
CE18TK |
|||
BASELINE DEVICE FAMILY |
CONTINUOUS EPIDURAL KIT |
|||
BASELINE DEVICE 510(K) NUMBER |
K840179 |
|||
BASELINE SHELF LIFE INFORMATION |
YES |
|||
IS BASELINE PMA NUMBER PROVIDED?</< TH> |
NO |
|||
BASELINE PREAMENDMENT? |
NO |
|||
TRANSITIONAL? |
NO |
|||
510(K) EXEMPT? |
NO |
|||
SHELF LIFE(Months) |
12 |
|||
DATE FIRST MARKETED |
02/24/1984 |
|||
MANUFACTURER (Section D) |
|
|||
DEVICE EVENT KEY |
393245 |
|||
MDR REPORT KEY |
404253 |
|||
EVENT KEY |
382060 |
|||
REPORT NUMBER |
404253 |
|||
DEVICE SEQUENCE NUMBER |
1 |
|||
PRODUCT CODE |
CAZ |
|||
REPORT SOURCE |
USER FACILITY |
|||
TYPE OF REPORT |
INITIAL |
|||
REPORT DATE |
06/27/2002 |
|||
1 DEVICE WAS INVOLVED IN THE EVENT |
|
|||
1 PATIENT WAS INVOLVED IN THE EVENT |
|
|||
DATE FDA RECEIVED |
07/09/2002 |
|||
IS THIS AN ADVERSE EVENT REPORT? |
YES |
|||
IS THIS A PRODUCT PROBLEM REPORT? |
NO |
|||
DEVICE OPERATOR |
HEALTH PROFESSIONAL |
|||
DEVICE EXPIRATION DATE |
10/31/2003 |
|||
DEVICE MODEL NUMBER |
CE18TK |
|||
DEVICE CATALOGUE NUMBER |
332220 |
|||
DEVICE LOT NUMBER |
60315607 |
|||
WAS DEVICE AVAILABLE FOR EVALUATION? |
YES |
|||
IS THE REPORTER A HEALTH PROFESSIONAL? |
YES |
|||
WAS THE REPORT SENT TO FDA? |
NO |
|||
DISTRIBUTOR FACILITY AWARE DATE |
06/08/2002 |
|||
DEVICE AGE |
UNKNOWN |
|||
EVENT LOCATION |
HOSPITAL |
|||
PATIENT OUTCOME |
HOSPITALIZATION |
ADVERSE EVENT OR PRODUCT PROBLEM DESCRIPTION |
REPORT DATE: 06/27/2002 MDR TEXT KEY: 1404325 Patient Sequence Number: 1 |
AS REPORTED BY USER FACILITY ON MEDWATCH: DURING REMOVAL OF THE EPIDURAL CATHETER IT STRETCHED AND BROKE. AS REPORTED BY USER FACILITY TO MFR: UPON REMOVAL OF THE EPIDURAL CATHETER RESISTANCE WAS MET AND WHEN THEY PULLED THE CATHETER OUT, IT WAS NOT INTACT. DR BELIEVES THIS WAS A 20G CLOSED TIP CATHETER. 5-6 CM WERE VISABLE ON CT SCAN. |
6.
BRAND NAME |
PERIFIX |
||||
TYPE OF DEVICE |
CONTINUOUS EPIDURAL TRAY |
||||
BASELINE BRAND NAME |
PERIFIX |
||||
BASELINE GENERIC NAME |
CONTINUOUS EPIDURAL TRAY |
||||
BASELINE CATALOGUE NUMBER |
332229 |
||||
BASELINE MODEL NUMBER |
CE17TKCD |
||||
BASELINE DEVICE FAMILY |
CONTINUOUS EPIDURAL KIT |
||||
BASELINE DEVICE 510(K) NUMBER |
K840179 |
||||
BASELINE SHELF LIFE INFORMATION |
YES |
||||
IS BASELINE PMA NUMBER PROVIDED?</< TH> |
NO |
||||
BASELINE PREAMENDMENT? |
NO |
||||
TRANSITIONAL? |
NO |
||||
510(K) EXEMPT? |
NO |
||||
SHELF LIFE(Months) |
12 |
||||
DATE FIRST MARKETED |
02/24/1984 |
||||
MANUFACTURER (Section F) |
|
||||
MANUFACTURER (Section D) |
|
||||
MANUFACTURER CONTACT |
|
||||
DEVICE EVENT KEY |
384788 |
||||
MDR REPORT KEY |
395781 |
||||
EVENT KEY |
373935 |
||||
REPORT NUMBER |
2523676-2002-00019 |
||||
DEVICE SEQUENCE NUMBER |
1 |
||||
PRODUCT CODE |
CAZ |
||||
REPORT SOURCE |
MANUFACTURER |
||||
SOURCE TYPE |
USER FACILITY |
||||
EVENT TYPE |
OTHER |
||||
TYPE OF REPORT |
INITIAL |
||||
REPORT DATE |
05/01/2002 |
||||
1 DEVICE WAS INVOLVED IN THE EVENT |
|
||||
1 PATIENT WAS INVOLVED IN THE EVENT |
|
||||
DATE FDA RECEIVED |
05/20/2002 |
||||
IS THIS AN ADVERSE EVENT REPORT? |
YES |
||||
IS THIS A PRODUCT PROBLEM REPORT? |
NO |
||||
DEVICE OPERATOR |
INVALID DATA |
||||
DEVICE EXPIRATION DATE |
07/31/2003 |
||||
IS THE REPORTER A HEALTH PROFESSIONAL? |
NO ANSWER PROVIDED |
||||
WAS THE REPORT SENT TO FDA? |
NO |
||||
DEVICE AGE |
UNKNOWN |
||||
DATE MANUFACTURER RECEIVED |
04/25/2002 |
||||
WAS DEVICE EVALUATED BY MANUFACTURER? |
DEVICE NOT RETURNED TO MANUFACTURER |
||||
IS THE DEVICE SINGLE USE? |
YES |
||||
TYPE OF DEVICE USAGE |
UNKNOWN |
ADDITIONAL MANUFACTURER NARRATIVE |
REPORT DATE: 05/20/2002 MDR TEXT KEY: 1373881 |
THE ACTUAL DEVICE IS NOT AVAILABLE FOR EVALUATION. BASED ON THE INFORMATION PROVIDED AT THIS TIME NO SPECIFIC CONCLUSIONS CAN BE DRAWN. THE PT HAS, TO DATE, SUFFERED NO ADVERSE EFFFECTS AS A RESULT OF THIS OCCURRENCE. IT SHOULD ALSO BE NOTED THAT THE LABELING ON THE TRAY STATES, "DO NOT WITHDRAW CATHETER THROUGH THE NEEDLE BECAUSE OF POSSIBLE DANGER OF SHEARING". |
7.
BRAND NAME |
PERIFIX |
||||
TYPE OF DEVICE |
CONTINUOUS EPIDURAL TRAY |
||||
BASELINE BRAND NAME |
PERIFIX |
||||
BASELINE GENERIC NAME |
CONTINUOUS EPIDURAL TRAY |
||||
BASELINE CATALOGUE NUMBER |
332230 |
||||
BASELINE MODEL NUMBER |
CE18HK |
||||
BASELINE DEVICE FAMILY |
CONTINUOUS EPIDURAL KIT |
||||
BASELINE DEVICE 510(K) NUMBER |
K840179 |
||||
BASELINE SHELF LIFE INFORMATION |
YES |
||||
IS BASELINE PMA NUMBER PROVIDED?</< TH> |
NO |
||||
BASELINE PREAMENDMENT? |
NO |
||||
TRANSITIONAL? |
NO |
||||
510(K) EXEMPT? |
NO |
||||
SHELF LIFE(Months) |
12 |
||||
DATE FIRST MARKETED |
02/24/1984 |
||||
MANUFACTURER (Section F) |
|
||||
MANUFACTURER (Section D) |
|
||||
MANUFACTURER CONTACT |
|
||||
DEVICE EVENT KEY |
384803 |
||||
MDR REPORT KEY |
395796 |
||||
EVENT KEY |
373950 |
||||
REPORT NUMBER |
2523676-2002-00018 |
||||
DEVICE SEQUENCE NUMBER |
1 |
||||
PRODUCT CODE |
CAZ |
||||
REPORT SOURCE |
MANUFACTURER |
||||
SOURCE TYPE |
USER FACILITY |
||||
REMEDIAL ACTION |
OTHER |
||||
EVENT TYPE |
INJURY |
||||
TYPE OF REPORT |
INITIAL |
||||
REPORT DATE |
04/30/2002 |
||||
1 DEVICE WAS INVOLVED IN THE EVENT |
|
||||
1 PATIENT WAS INVOLVED IN THE EVENT |
|
||||
DATE FDA RECEIVED |
05/20/2002 |
||||
IS THIS AN ADVERSE EVENT REPORT? |
YES |
||||
IS THIS A PRODUCT PROBLEM REPORT? |
NO |
||||
DEVICE OPERATOR |
HEALTH PROFESSIONAL |
||||
DEVICE EXPIRATION DATE |
08/31/2003 |
||||
DEVICE MODEL NUMBER |
CE18HK |
||||
DEVICE CATALOGUE NUMBER |
332230 |
||||
DEVICE LOT NUMBER |
60293189 |
||||
WAS DEVICE AVAILABLE FOR EVALUATION? |
YES |
||||
IS THE REPORTER A HEALTH PROFESSIONAL? |
YES |
||||
WAS THE REPORT SENT TO FDA? |
NO |
||||
DISTRIBUTOR FACILITY AWARE DATE |
03/22/2002 |
||||
DEVICE AGE |
UNKNOWN |
||||
EVENT LOCATION |
HOSPITAL |
||||
DATE MANUFACTURER RECEIVED |
04/23/2002 |
||||
WAS DEVICE EVALUATED BY MANUFACTURER? |
DEVICE NOT RETURNED TO MANUFACTURER |
||||
DATE DEVICE MANUFACTURED |
01/01/2002 |
||||
IS THE DEVICE SINGLE USE? |
YES |
||||
TYPE OF DEVICE USAGE |
UNKNOWN |
||||
PATIENT OUTCOME |
OTHER |
ADVERSE EVENT OR PRODUCT PROBLEM DESCRIPTION |
REPORT DATE: 04/30/2002 MDR TEXT KEY: 1373932 Patient Sequence Number: 1 |
USER FACILITY REPORTS THE FOLLOWING: 1. CATHETER PLACE ATRAUMATICALLY INTO PATIENT. 2. DR. ATTEMPTED TO REMOVE EPIDURAL TWO HOURS LATER WHILE PATIENT WAS LYING DOWN AND MET RESISTANCE. 3. DR. HAD THE PATIENT SIT UP AND LEAN FORWARD AND STILL MET RESISTANCE WHILE ATTEMPTING TO REMOVE THE CATHETER. DR CONTINUED PULLING ON CATHETER FOR WHICH IT STRETCHED AND WHEN REMOVED, THE "BLUE TIP" WAS MISSING. 4. FRAGMENT LEFT IN PATIENT'S BACK. 5. DR MADE FOLLOW-UP CALL TO THE PATIENT APRIL 16TH FOR WHICH THE PATIENT WAS ASYMPTOMATIC. 6. DR WILL NOT RELEASE THE SAMPLE. |
|
ADDITIONAL MANUFACTURER NARRATIVE |
REPORT DATE: 04/30/2002 MDR TEXT KEY: 1373935 |
THE ACTUAL SAMPLE WAS REQUESTED FOR NON-DESTRUCTIVE ANALYSIS, HOWEVER, THE DR. WILL NOT RELEASE THE SAMPLE. BASED ON THE INFORMATION PROVIDED AT THIS TIME NO SPECIFIC CONCLUSIONS CAN BE DRAWN. THE PATIENT HAS, TO DATE, SUFFERED NO ADVERSE EFFECTS AS A RESULT OF THIS OCCURRENCE. IF THE ACTUAL SAMPLE, OR ADDITIONAL INFORMATION IN RECEIVED, A FOLLOW-UP REPORT WILL BE FILED. |
8.
BRAND NAME |
PERIFIX |
|||
TYPE OF DEVICE |
CONTINUOUS EPIDURAL TRAY |
|||
BASELINE BRAND NAME |
PERIFIX |
|||
BASELINE GENERIC NAME |
CONTINUOUS EPIDURAL TRAY |
|||
BASELINE CATALOGUE NUMBER |
332220 |
|||
BASELINE MODEL NUMBER |
CE18TK |
|||
BASELINE DEVICE FAMILY |
CONTINUOUS EPIDURAL KIT |
|||
BASELINE DEVICE 510(K) NUMBER |
K840179 |
|||
BASELINE SHELF LIFE INFORMATION |
YES |
|||
IS BASELINE PMA NUMBER PROVIDED?</< TH> |
NO |
|||
BASELINE PREAMENDMENT? |
NO |
|||
TRANSITIONAL? |
NO |
|||
510(K) EXEMPT? |
NO |
|||
SHELF LIFE(Months) |
12 |
|||
DATE FIRST MARKETED |
02/24/1984 |
|||
MANUFACTURER (Section F) |
|
|||
MANUFACTURER (Section D) |
|
|||
DEVICE EVENT KEY |
379763 |
|||
MDR REPORT KEY |
390720 |
|||
EVENT KEY |
369032 |
|||
REPORT NUMBER |
390720 |
|||
DEVICE SEQUENCE NUMBER |
1 |
|||
PRODUCT CODE |
CAZ |
|||
REPORT SOURCE |
USER FACILITY |
|||
TYPE OF REPORT |
INITIAL |
|||
REPORT DATE |
04/16/2002 |
|||
1 DEVICE WAS INVOLVED IN THE EVENT |
|
|||
1 PATIENT WAS INVOLVED IN THE EVENT |
|
|||
DATE FDA RECEIVED |
04/16/2002 |
|||
IS THIS AN ADVERSE EVENT REPORT? |
YES |
|||
IS THIS A PRODUCT PROBLEM REPORT? |
NO |
|||
DEVICE OPERATOR |
HEALTH PROFESSIONAL |
|||
DEVICE MODEL NUMBER |
CE18TK |
|||
DEVICE CATALOGUE NUMBER |
332220 |
|||
WAS DEVICE AVAILABLE FOR EVALUATION? |
YES |
|||
IS THE REPORTER A HEALTH PROFESSIONAL? |
YES |
|||
WAS THE REPORT SENT TO FDA? |
NO |
|||
DISTRIBUTOR FACILITY AWARE DATE |
03/27/2002 |
|||
DEVICE AGE |
UNKNOWN |
|||
EVENT LOCATION |
HOSPITAL |
|||
DATE REPORT TO MANUFACTURER |
04/03/2002 |
|||
PATIENT OUTCOME |
OTHER |
ADVERSE EVENT OR PRODUCT PROBLEM DESCRIPTION |
REPORT DATE: 04/16/2002 MDR TEXT KEY: 1356831 Patient Sequence Number: 1 |
FACILITY REPORTS THE FOLLOWING: ONE DAY FOLLOWING INSERTION OF EPIDURAL CATHETER IT BECAME OCCLUDED AND WAS REMOVED. ONE-HALF OF THE TIP WAS NOTED TO BE MISSING AND WAS BELIEVED TO BE REMAINING IN PT. PT EVALUATED. CONTINUES TO BE WITHOUT MOTOR OR SENSORY DEFICITS. |
9.
BRAND NAME |
PERIFIX |
||||
TYPE OF DEVICE |
EPIDURAL CATHETER |
||||
BASELINE BRAND NAME |
PERIFIX |
||||
BASELINE GENERIC NAME |
EPIDURAL CATHETER |
||||
BASELINE CATALOGUE NUMBER |
332204 |
||||
BASELINE MODEL NUMBER |
CE17TO |
||||
BASELINE DEVICE FAMILY |
EPIDURAL CATHETER |
||||
BASELINE DEVICE 510(K) NUMBER |
K813186 |
||||
BASELINE SHELF LIFE INFORMATION |
* |
||||
IS BASELINE PMA NUMBER PROVIDED?</< TH> |
NO |
||||
BASELINE PREAMENDMENT? |
NO |
||||
TRANSITIONAL? |
NO |
||||
510(K) EXEMPT? |
NO |
||||
SHELF LIFE(Months) |
12 |
||||
DATE FIRST MARKETED |
12/11/1981 |
||||
MANUFACTURER (Section F) |
|
||||
MANUFACTURER (Section D) |
|
||||
MANUFACTURER CONTACT |
|
||||
DEVICE EVENT KEY |
365379 |
||||
MDR REPORT KEY |
376291 |
||||
EVENT KEY |
355081 |
||||
REPORT NUMBER |
2523676-2002-00002 |
||||
DEVICE SEQUENCE NUMBER |
1 |
||||
PRODUCT CODE |
CAZ |
||||
REPORT SOURCE |
MANUFACTURER |
||||
SOURCE TYPE |
USER FACILITY |
||||
REMEDIAL ACTION |
OTHER |
||||
EVENT TYPE |
OTHER |
||||
TYPE OF REPORT |
INITIAL,FOLLOWUP |
||||
REPORT DATE |
02/01/2002 |
||||
1 DEVICE WAS INVOLVED IN THE EVENT |
|
||||
1 PATIENT WAS INVOLVED IN THE EVENT |
|
||||
DATE FDA RECEIVED |
02/07/2002 |
||||
IS THIS AN ADVERSE EVENT REPORT? |
YES |
||||
IS THIS A PRODUCT PROBLEM REPORT? |
NO |
||||
DEVICE OPERATOR |
HEALTH PROFESSIONAL |
||||
DEVICE MODEL NUMBER |
CE17TO |
||||
DEVICE CATALOGUE NUMBER |
332204 |
||||
WAS DEVICE AVAILABLE FOR EVALUATION? |
YES |
||||
IS THE REPORTER A HEALTH PROFESSIONAL? |
NO |
||||
WAS THE REPORT SENT TO FDA? |
NO |
||||
DISTRIBUTOR FACILITY AWARE DATE |
11/14/2001 |
||||
DEVICE AGE |
UNKNOWN |
||||
EVENT LOCATION |
HOSPITAL |
||||
DATE MANUFACTURER RECEIVED |
01/07/2002 |
||||
WAS DEVICE EVALUATED BY MANUFACTURER? |
YES |
||||
IS THE DEVICE SINGLE USE? |
YES |
||||
TYPE OF DEVICE USAGE |
INITIAL |
||||
PATIENT OUTCOME |
OTHER |
ADVERSE EVENT OR PRODUCT PROBLEM DESCRIPTION |
REPORT DATE: 02/01/2002 MDR TEXT KEY: 1308540 Patient Sequence Number: 1 |
THE USER FACILITY REPORTED THE FOLLOWING: CATHETER TIP SHEARED OFF IN PT WHILE REMOVING. AT PRESENT, CATHETER FRAGMENT REMAINS ASYMPTOMATICALLY IN PT'S BACK. |
|
ADDITIONAL MANUFACTURER NARRATIVE |
REPORT DATE: 02/01/2002 MDR TEXT KEY: 1308543 |
THE EPIDURAL CATHETER WAS RETURNED FOR EVAL. THE CATHETER WAS NOT STRETCHED. APPROXIMATELY 8MM OF THE CATHETER WAS SHEARED OFF. BECAUSE THE CATHETER WAS SHEARED, IT IS MOST POSSIBLE THAT USER ERROR CONTRIBUTED TO THE EVENT. IT SHOULD BE NOTED THAT THE LABELING ON THE TRAY STATES: "DO NOT WITHDRAW CATHETER THROUGH NEEDLE DUE TO POSSIBLE DANGER OF SHEARING". |
|
ADDITIONAL MANUFACTURER NARRATIVE |
REPORT DATE: 02/01/2002 MDR TEXT KEY: 1393296 |
THE ACTUAL SAMPLE RECEIVED BY B. BRAUN MEDICAL, INC. WAS FORWARDED TO THE MFR B. BRAUN MELSUNGEN AG FOR EVAL. B. BRAUN MELSUNGEN AG'S EXAMINATION RESULTS ARE AS FOLLOWS: "THE USED CATHETER IS CUT APPROX 25MM FROM THE TIP. EXAMINATION BY MICROSCOPE CLEARLY SHOWED AN OVERSTRETCHED CATHETER WITH TYPICAL DAMAGES. REASON FOR THIS COULD ONLY BE THE WITHDRAWAL OF THE CATHETER THROUGH THE EPIDURAL NEEDLE. IN THE INSTRUCTIONS FOR USE A STRICT WARNING AGAINST THIS PROCEDURE IS EXPRESSED BECAUSE OF THE EXISTING RISK THAT THE CATHETER COULD SHEAR OFF." |
10.
BRAND NAME |
PERIFIX |
||||
TYPE OF DEVICE |
CUSTOM EPIDURAL SPINAL KIT |
||||
BASELINE BRAND NAME |
PERIFIX |
||||
BASELINE GENERIC NAME |
CUSTOM EPIDURAL SPINAL KIT |
||||
BASELINE CATALOGUE NUMBER |
555522 |
||||
BASELINE MODEL NUMBER |
CESJ |
||||
MANUFACTURER (Section F) |
|
||||
MANUFACTURER (Section D) |
|
||||
MANUFACTURER CONTACT |
|
||||
DEVICE EVENT KEY |
355097 |
||||
MDR REPORT KEY |
365974 |
||||
EVENT KEY |
345069 |
||||
REPORT NUMBER |
2523676-2001-00057 |
||||
DEVICE SEQUENCE NUMBER |
1 |
||||
PRODUCT CODE |
CAZ |
||||
REPORT SOURCE |
MANUFACTURER |
||||
SOURCE TYPE |
USER FACILITY |
||||
REMEDIAL ACTION |
OTHER |
||||
EVENT TYPE |
INJURY |
||||
TYPE OF REPORT |
INITIAL |
||||
REPORT DATE |
12/05/2001 |
||||
1 DEVICE WAS INVOLVED IN THE EVENT |
|
||||
1 PATIENT WAS INVOLVED IN THE EVENT |
|
||||
DATE FDA RECEIVED |
12/12/2001 |
||||
IS THIS AN ADVERSE EVENT REPORT? |
YES |
||||
IS THIS A PRODUCT PROBLEM REPORT? |
NO |
||||
DEVICE OPERATOR |
HEALTH PROFESSIONAL |
||||
DEVICE MODEL NUMBER |
CESJ |
||||
DEVICE CATALOGUE NUMBER |
555522 |
||||
WAS DEVICE AVAILABLE FOR EVALUATION? |
DEVICE NOT RETURNED TO MANUFACTURER |
||||
DATE RETURNED TO MANUFACTURER |
12/03/2001 |
||||
IS THE REPORTER A HEALTH PROFESSIONAL? |
YES |
||||
WAS THE REPORT SENT TO FDA? |
NO |
||||
DISTRIBUTOR FACILITY AWARE DATE |
11/12/2001 |
||||
DEVICE AGE |
UNKNOWN |
||||
EVENT LOCATION |
HOSPITAL |
||||
DATE MANUFACTURER RECEIVED |
11/12/2001 |
||||
WAS DEVICE EVALUATED BY MANUFACTURER? |
YES |
||||
IS THE DEVICE SINGLE USE? |
YES |
||||
TYPE OF DEVICE USAGE |
INITIAL |
||||
PATIENT OUTCOME |
OTHER |
ADVERSE EVENT OR PRODUCT PROBLEM DESCRIPTION |
REPORT DATE: 12/05/2001 MDR TEXT KEY: 1271188 Patient Sequence Number: 1 |
THE USER FACILITY REPORTED THE FOLLOWING : "DURING REMOVAL OF AN EPIDURAL CATHETER FROM A SURGICAL PT, THE NURSE MET WITH SLIGHT RESISTANCE BUT CONTINUED TO REMOVE. UPON REMOVAL OF THE CATHETER THE NURSE NOTICED THAT THE TIP WAS MISSING (APPROX 2-3CM). PT WAS DISCHARGED WITHOUT INTERVENTION". |
|
ADDITIONAL MANUFACTURER NARRATIVE |
REPORT DATE: 12/12/2001 MDR TEXT KEY: 1271191 |
THE RETURNED CATHETER WAS MISSING AN UNKNOWN PORTION OF THE DISTAL TIP. THE CATHETER APPEARED STRETCHED AND ELONGATED WITH A REDUCTION IN THE OUTER DIAMETER INDICATING THAT THE CATHETER HAD BECOME LODGED BETWEEN TWO RIGID BODY STRUCTURES AND STRETCHED BEYOND ITS INTENDED DESIGN CAPABILITIES. THIS OCCURRENCE DID NOT APPEAR TO BE THE RESULT OF ANY PRODUCT QUALITY DEFICIENCIES OR PRODUCT MALFUNCTION. THE PT WAS RELEASED WITHOUT INTERVENTION. NO FURTHER INFO REGARDING PT'S CONDITION HAS BEEN COMMUNICATED TO B. BRAUN MEDICAL. IT SHOULD BE NOTED THAT THE LABELING ON THE TRAY STATES: "DO NOT WITHDRAW CATHETER THROUGH THE NEEDLE BECAUSE OF POSSIBLE DANGER OF SHEARING". |
11.
BRAND NAME |
PERIFIX |
||||
TYPE OF DEVICE |
CONTINUOUS EPIDURAL TRAY |
||||
BASELINE BRAND NAME |
PERIFIX |
||||
BASELINE GENERIC NAME |
EPIDURAL CATHETER |
||||
BASELINE CATALOGUE NUMBER |
332221 |
||||
BASELINE MODEL NUMBER |
CE17TK |
||||
BASELINE DEVICE FAMILY |
EPIDURAL CATHETER |
||||
BASELINE DEVICE 510(K) NUMBER |
K840179 |
||||
BASELINE SHELF LIFE INFORMATION |
YES |
||||
IS BASELINE PMA NUMBER PROVIDED?</< TH> |
NO |
||||
BASELINE PREAMENDMENT? |
NO |
||||
TRANSITIONAL? |
NO |
||||
510(K) EXEMPT? |
NO |
||||
SHELF LIFE(Months) |
12 |
||||
DATE FIRST MARKETED |
02/24/1984 |
||||
MANUFACTURER (Section F) |
|
||||
MANUFACTURER (Section D) |
|
||||
MANUFACTURER CONTACT |
|
||||
DEVICE EVENT KEY |
350006 |
||||
MDR REPORT KEY |
360848 |
||||
EVENT KEY |
340118 |
||||
REPORT NUMBER |
2523676-2001-00054 |
||||
DEVICE SEQUENCE NUMBER |
1 |
||||
PRODUCT CODE |
CAZ |
||||
REPORT SOURCE |
MANUFACTURER |
||||
SOURCE TYPE |
USER FACILITY |
||||
REMEDIAL ACTION |
OTHER |
||||
EVENT TYPE |
INJURY |
||||
TYPE OF REPORT |
INITIAL,FOLLOWUP |
||||
REPORT DATE |
10/10/2001 |
||||
1 DEVICE WAS INVOLVED IN THE EVENT |
|
||||
1 PATIENT WAS INVOLVED IN THE EVENT |
|
||||
DATE FDA RECEIVED |
11/09/2001 |
||||
IS THIS AN ADVERSE EVENT REPORT? |
YES |
||||
IS THIS A PRODUCT PROBLEM REPORT? |
NO |
||||
DEVICE OPERATOR |
HEALTH PROFESSIONAL |
||||
DEVICE EXPIRATION DATE |
05/31/2003 |
||||
DEVICE MODEL NUMBER |
CE17TK |
||||
DEVICE CATALOGUE NUMBER |
332221 |
||||
DEVICE LOT NUMBER |
60232525 |
||||
WAS DEVICE AVAILABLE FOR EVALUATION? |
YES |
||||
IS THE REPORTER A HEALTH PROFESSIONAL? |
YES |
||||
WAS THE REPORT SENT TO FDA? |
NO |
||||
DISTRIBUTOR FACILITY AWARE DATE |
10/04/2001 |
||||
DEVICE AGE |
UNKNOWN |
||||
EVENT LOCATION |
HOSPITAL |
||||
DATE MANUFACTURER RECEIVED |
10/25/2001 |
||||
WAS DEVICE EVALUATED BY MANUFACTURER? |
YES |
||||
DATE DEVICE MANUFACTURED |
07/01/2001 |
||||
IS THE DEVICE SINGLE USE? |
YES |
||||
TYPE OF DEVICE USAGE |
UNKNOWN |
||||
PATIENT OUTCOME |
REQUIRED INTERVENTION |
ADVERSE EVENT OR PRODUCT PROBLEM DESCRIPTION |
REPORT DATE: 10/10/2001 MDR TEXT KEY: 1253834 Patient Sequence Number: 1 |
USER FACILITY REPORTED THE FOLLOWING: "CATHETER WAS REMOVED BY BY "FLOOR NURSE", RESISTANCE WAS MET, CONTINUED TO PULL AT CATHETER, STRETCHING SAME. CATHETER SNAPPED AND WAS REMOVED. UPON INSPECTION AND COMPARISON WITH A NEW CATHETER, IT WAS NOTED THAT THE BLUE TIP OF THE REMOVED CATHETER WAS MISSING". NO FURTHER INFO WAS PROVIDED REGARDING THE CIRCUMSTANCES SURROUNDING THIS EVENT. |
|
ADDITIONAL MANUFACTURER NARRATIVE |
REPORT DATE: 10/10/2001 MDR TEXT KEY: 1253836 |
THE RETURNED PORTION OF THE CATHETER WAS MISSING THE DISTAL TIP. THE CATHETER APPEARED STRETCHED AND ELONGATED WITH A REDUCTION IN THE OUTER DIAMETER, INDICATING THAT THE CATHETER HAD BECOME LODGED BETWEEN TWO RIGID BODY STRUCTURES AND STRETCHED BEYOND ITS INTENDED DESIGN CAPABILITIES. THIS OCCURRENCE DID NOT APPEAR TO BE THE RESULT OF ANY PRODUCT QUALITY DEFICIENCIES OR PRODUCT MALFUNCTION. IT SHOULD ALSO BE NOTED THAT THE LABELING ON THE TRAY STATES, "DO NOT WITHDRAWAL CATHETER THROUGH THE NEEDLE BECAUSE OF POSSIBLE DANGER OF SHEARING". |
|
ADDITIONAL MANUFACTURER NARRATIVE |
REPORT DATE: 10/10/2001 MDR TEXT KEY: 1391964 |
THE ACTUAL SAMPLE RETURNED TO B. BRAUN MEDICAL, INC. WAS FORWARDED TO THE MFR. B. BRAUN MELSUNGEN AG. B. BRAUN MELSUNGEN'S EXAMINATION RESULTS ARE AS FOLLOWS: "VISUAL INSPECTION BY MICROSCOPE SHOWS AN OVERSTRETCHED CATHETER. ATTENUATION MARKS OR OTHER SIGNS AS A CONSEQUENCE OF MFG PROBLEMS ARE NOT VISIBLE. CO SUPPOSES THAT THE CATHETER WAS JAMMED BECAUSE OF THE ANATOMIC CIRCUMSTANCES AND THEN SNAPPED AS A RESULT OF TOO HIGH TENSILE FORCES DURING PULLING." |
12.
BRAND NAME |
PERIFIX |
||||
TYPE OF DEVICE |
CONTINUOUS EPIDURAL TRAY |
||||
BASELINE BRAND NAME |
PERIFIX |
||||
BASELINE GENERIC NAME |
EPIDURAL CATHETER |
||||
BASELINE CATALOGUE NUMBER |
332221 |
||||
BASELINE MODEL NUMBER |
CE17TK |
||||
BASELINE DEVICE FAMILY |
EPIDURAL CATHETER |
||||
BASELINE DEVICE 510(K) NUMBER |
K840179 |
||||
BASELINE SHELF LIFE INFORMATION |
YES |
||||
IS BASELINE PMA NUMBER PROVIDED?</< TH> |
NO |
||||
BASELINE PREAMENDMENT? |
NO |
||||
TRANSITIONAL? |
NO |
||||
510(K) EXEMPT? |
NO |
||||
SHELF LIFE(Months) |
12 |
||||
DATE FIRST MARKETED |
02/24/1984 |
||||
MANUFACTURER (Section F) |
|
||||
MANUFACTURER (Section D) |
|
||||
MANUFACTURER CONTACT |
|
||||
DEVICE EVENT KEY |
341679 |
||||
MDR REPORT KEY |
352410 |
||||
EVENT KEY |
332016 |
||||
REPORT NUMBER |
2523676-2001-00048 |
||||
DEVICE SEQUENCE NUMBER |
1 |
||||
PRODUCT CODE |
CAZ |
||||
REPORT SOURCE |
MANUFACTURER |
||||
SOURCE TYPE |
USER FACILITY |
||||
REMEDIAL ACTION |
OTHER |
||||
EVENT TYPE |
INJURY |
||||
TYPE OF REPORT |
INITIAL |
||||
REPORT DATE |
08/22/2001 |
||||
1 DEVICE WAS INVOLVED IN THE EVENT |
|
||||
1 PATIENT WAS INVOLVED IN THE EVENT |
|
||||
DATE FDA RECEIVED |
09/19/2001 |
||||
IS THIS AN ADVERSE EVENT REPORT? |
YES |
||||
IS THIS A PRODUCT PROBLEM REPORT? |
NO |
||||
DEVICE OPERATOR |
HEALTH PROFESSIONAL |
||||
DEVICE MODEL NUMBER |
CE17TK |
||||
DEVICE CATALOGUE NUMBER |
332221 |
||||
DEVICE LOT NUMBER |
60217828 |
||||
WAS DEVICE AVAILABLE FOR EVALUATION? |
YES |
||||
IS THE REPORTER A HEALTH PROFESSIONAL? |
YES |
||||
WAS THE REPORT SENT TO FDA? |
NO |
||||
DISTRIBUTOR FACILITY AWARE DATE |
08/21/2001 |
||||
DEVICE AGE |
UNKNOWN |
||||
EVENT LOCATION |
HOSPITAL |
||||
DATE MANUFACTURER RECEIVED |
08/22/2001 |
||||
WAS DEVICE EVALUATED BY MANUFACTURER? |
YES |
||||
IS THE DEVICE SINGLE USE? |
YES |
||||
TYPE OF DEVICE USAGE |
UNKNOWN |
||||
PATIENT OUTCOME |
OTHER |
ADVERSE EVENT OR PRODUCT PROBLEM DESCRIPTION |
REPORT DATE: 08/22/2001 MDR TEXT KEY: 1223394 Patient Sequence Number: 1 |
THE USER FACILITY REPORTED THE FOLLOWING: "WHEN EPIDURAL CATHETER WAS BEING REMOVED, MODERATE RESISTANCE WAS MET AND A SNAPPING SOUND WAS HEARD. UPON REMOVAL OF THE CATHETER, THE LAST 1 CM TIP WAS MISSING". NO FURTHER INFORMATION WAS PROVIDED BY THE USER FACILITY REGARDING THE CIRCUMSTANCES SURROUNDING THE EVENT. |
|
ADDITIONAL MANUFACTURER NARRATIVE |
REPORT DATE: 09/19/2001 MDR TEXT KEY: 1223397 |
THE RETURNED SAMPLE DID NOT EXHIBIT ANY VISIBLE MANUFACTUING RELATED DEFECTS, HOWEVER. A SEGMENT OF THE CATHETER OF UNKNOWN LENGTH WAS MISSING FROM THE DISTAL TIP. THE INFORMATION PROVIDED BY THE USER FACILITY, AND THE APPEARANCE OF THE RETURED SAMPLE, INDICATE THAT THE CATHETER HAD BECOME LODGED BETWEEN RIGID BODY STRUCTURES, AND STRETCHED BEYOND IT'S INTENDED DESIGN CAPABILITIES DURING REMOVAL. THIS OCCURRENCE DID NOT APPEAR TO BE THE RESULT OF ANY PRODUCT QUALITY DEFICIENCIES OR PRODUCT MALFUNCTION. NO FURTHER INFORMATION IS AVAILABLE ON THE PATIENT'S STATUS. IT SHOULD ALSO BE NOTED THAT THE LABELING ON THE TRAYS STATES, "DO NOT WITHDRAWAL CATHETER THROUGH THE NEELDLE BECAUSE OF POSSIBLE DANGER OF SHEARING". |
|
13.
BRAND NAME |
PERIFIX |
|||
TYPE OF DEVICE |
EPIDURAL TRAY |
|||
BASELINE BRAND NAME |
PERIFIX |
|||
BASELINE GENERIC NAME |
EPIDURAL TRAY |
|||
BASELINE CATALOGUE NUMBER |
332217 |
|||
BASELINE MODEL NUMBER |
CE18TK-10L |
|||
MANUFACTURER (Section D) |
|
|||
DEVICE EVENT KEY |
341016 |
|||
MDR REPORT KEY |
351731 |
|||
EVENT KEY |
331349 |
|||
REPORT NUMBER |
351731 |
|||
DEVICE SEQUENCE NUMBER |
1 |
|||
PRODUCT CODE |
CAZ |
|||
REPORT SOURCE |
USER FACILITY |
|||
TYPE OF REPORT |
INITIAL |
|||
REPORT DATE |
08/13/2001 |
|||
1 DEVICE WAS INVOLVED IN THE EVENT |
|
|||
1 PATIENT WAS INVOLVED IN THE EVENT |
|
|||
DATE FDA RECEIVED |
09/14/2001 |
|||
IS THIS AN ADVERSE EVENT REPORT? |
YES |
|||
IS THIS A PRODUCT PROBLEM REPORT? |
NO |
|||
DEVICE OPERATOR |
HEALTH PROFESSIONAL |
|||
DEVICE EXPIRATION DATE |
03/01/2003 |
|||
DEVICE MODEL NUMBER |
CE18TK-10L |
|||
DEVICE CATALOGUE NUMBER |
332217 |
|||
DEVICE LOT NUMBER |
60229008 |
|||
WAS DEVICE AVAILABLE FOR EVALUATION? |
YES |
|||
IS THE REPORTER A HEALTH PROFESSIONAL? |
YES |
|||
WAS THE REPORT SENT TO FDA? |
NO |
|||
DISTRIBUTOR FACILITY AWARE DATE |
08/08/2001 |
|||
DEVICE AGE |
UNKNOWN |
|||
EVENT LOCATION |
HOSPITAL |
|||
DATE REPORT TO MANUFACTURER |
08/13/2001 |
|||
PATIENT OUTCOME |
OTHER |
ADVERSE EVENT OR PRODUCT PROBLEM DESCRIPTION |
REPORT DATE: 08/13/2001 MDR TEXT KEY: 1220842 Patient Sequence Number: 1 |
THE USER FACILITY REPORTED THE FOLLOWING: "APPROX 2MM TIP OF EPIDURAL CATHETER REMAINED IN PT WHEN PULLED BY ANESTHESIOLOGIST. NEUROSURGICAL CONSULT OBTAINED; NO ADDITIONAL INTERVENTION REQUIRED AT THIS TIME". |
14.
BRAND NAME |
PERIFIX |
||||
TYPE OF DEVICE |
CESK TRAY |
||||
BASELINE BRAND NAME |
PERIFIX |
||||
BASELINE GENERIC NAME |
CUSTOM EPIDURAL TRAY |
||||
BASELINE CATALOGUE NUMBER |
555861 |
||||
BASELINE MODEL NUMBER |
CESK |
||||
BASELINE DEVICE FAMILY |
CONTINUOUS EPIDURAL TRAYS |
||||
BASELINE DEVICE 510(K) NUMBER |
K813186 |
||||
BASELINE SHELF LIFE INFORMATION |
YES |
||||
IS BASELINE PMA NUMBER PROVIDED?</< TH> |
NO |
||||
BASELINE PREAMENDMENT? |
NO |
||||
TRANSITIONAL? |
NO |
||||
510(K) EXEMPT? |
NO |
||||
SHELF LIFE(Months) |
12 |
||||
DATE FIRST MARKETED |
12/03/1981 |
||||
MANUFACTURER (Section F) |
|
||||
MANUFACTURER (Section D) |
|
||||
MANUFACTURER CONTACT |
|
||||
DEVICE EVENT KEY |
339216 |
||||
MDR REPORT KEY |
349910 |
||||
EVENT KEY |
329595 |
||||
REPORT NUMBER |
2523676-2001-00041 |
||||
DEVICE SEQUENCE NUMBER |
1 |
||||
PRODUCT CODE |
CAZ |
||||
REPORT SOURCE |
MANUFACTURER |
||||
SOURCE TYPE |
HEALTH PROFESSIONAL |
||||
REMEDIAL ACTION |
OTHER |
||||
EVENT TYPE |
INJURY |
||||
TYPE OF REPORT |
INITIAL |
||||
REPORT DATE |
08/30/2001 |
||||
1 DEVICE WAS INVOLVED IN THE EVENT |
|
||||
1 PATIENT WAS INVOLVED IN THE EVENT |
|
||||
DATE FDA RECEIVED |
08/31/2001 |
||||
IS THIS AN ADVERSE EVENT REPORT? |
YES |
||||
IS THIS A PRODUCT PROBLEM REPORT? |
NO |
||||
DEVICE OPERATOR |
HEALTH PROFESSIONAL |
||||
DEVICE EXPIRATION DATE |
02/28/2006 |
||||
DEVICE MODEL NUMBER |
CESK |
||||
DEVICE CATALOGUE NUMBER |
555579 |
||||
DEVICE LOT NUMBER |
060201505 |
||||
WAS DEVICE AVAILABLE FOR EVALUATION? |
NO |
||||
IS THE REPORTER A HEALTH PROFESSIONAL? |
YES |
||||
WAS THE REPORT SENT TO FDA? |
NO |
||||
DISTRIBUTOR FACILITY AWARE DATE |
08/08/2001 |
||||
DEVICE AGE |
6 MO |
||||
EVENT LOCATION |
HOSPITAL |
||||
DATE REPORT TO MANUFACTURER |
08/21/2001 |
||||
WAS DEVICE EVALUATED BY MANUFACTURER? |
DEVICE NOT RETURNED TO MANUFACTURER |
||||
DATE DEVICE MANUFACTURED |
02/01/2001 |
||||
IS THE DEVICE SINGLE USE? |
YES |
||||
TYPE OF DEVICE USAGE |
UNKNOWN |
||||
PATIENT OUTCOME |
REQUIRED INTERVENTION |
ADVERSE EVENT OR PRODUCT PROBLEM DESCRIPTION |
REPORT DATE: 08/30/2001 MDR TEXT KEY: 1214068 Patient Sequence Number: 1 |
THE MEDWATCH REPORT RECEIVED FROM THE USER FACILITY STATES THE FOLLOWING: "PATIENT TO HAVE EPIDURAL PLACED BY ANESTHESIOLOGIST PRIOR TO PROCEDURE. THE EPIDURAL CATHETER WAS INTRODUCED BETWEEN THE THIRD AND FOURTH VERTEBRAE. RESISTANCE WAS MET AND THE CATHETER COULD NOT BE ADVANCED. AS THE CATHETER WAS REMOVED, THE TIP WAS SHEARED OFF. APPROXIMATELY 1MM OF THE CATHETER TIP REMAINED IN THE PATIENT. PATIENT HAD NO ADVERSE REACTIONS REPORTED ON DISCHARGE FROM THE HOSPITAL." |
|
ADDITIONAL MANUFACTURER NARRATIVE |
REPORT DATE: 08/31/2001 MDR TEXT KEY: 1214071 |
THE SAMPLE HAS BEEN REQUESTED, BUT HAS NOT YET BEEN RETURNED. NO CONCLUSION CAN BE DRAWN SINCE THE PRODUCT WAS NOT RETURNED FOR EVAL. IT SHOULD BE NOTED THAT THE LABELING ON THE TRAY STATES, "DO NOT WITHDRAW CATHETER THROUGH THE NEEDLE BECAUSE OF POSSIBLE DANGER OF SHEARING". NO FURTHER INFORMATION IS AVAILABLE ON THE PATIENT'S STATUS. |
15.
BRAND NAME |
PERIFIX CONTINUOUS EPIDURAL ANESTHESIA TRAY |
|||
TYPE OF DEVICE |
RADIOPAQUE POLYAMIDE EPIDURAL CATH 20 GA CLOSED TIP |
|||
MANUFACTURER (Section F) |
|
|||
MANUFACTURER (Section D) |
|
|||
DEVICE EVENT KEY |
339787 |
|||
MDR REPORT KEY |
350492 |
|||
EVENT KEY |
330165 |
|||
REPORT NUMBER |
350492 |
|||
DEVICE SEQUENCE NUMBER |
1 |
|||
PRODUCT CODE |
CAZ |
|||
REPORT SOURCE |
USER FACILITY |
|||
TYPE OF REPORT |
INITIAL |
|||
REPORT DATE |
08/27/2001 |
|||
1 DEVICE WAS INVOLVED IN THE EVENT |
|
|||
1 PATIENT WAS INVOLVED IN THE EVENT |
|
|||
DATE FDA RECEIVED |
08/28/2001 |
|||
IS THIS AN ADVERSE EVENT REPORT? |
YES |
|||
IS THIS A PRODUCT PROBLEM REPORT? |
YES |
|||
DEVICE OPERATOR |
HEALTH PROFESSIONAL |
|||
DEVICE MODEL NUMBER |
CE18TK |
|||
WAS DEVICE AVAILABLE FOR EVALUATION? |
NO |
|||
IS THE REPORTER A HEALTH PROFESSIONAL? |
YES |
|||
WAS THE REPORT SENT TO FDA? |
YES |
|||
DATE REPORT TO FDA |
08/27/2001 |
|||
DISTRIBUTOR FACILITY AWARE DATE |
08/24/2001 |
|||
EVENT LOCATION |
HOSPITAL |
|||
DATE REPORT TO MANUFACTURER |
08/27/2001 |
|||
PATIENT OUTCOME |
OTHER |
ADVERSE EVENT OR PRODUCT PROBLEM DESCRIPTION |
REPORT DATE: 08/27/2001 MDR TEXT KEY: 1216370 Patient Sequence Number: 1 |
EPIDURAL CATHETER TIP BROKE OFF WHEN MD ATTEMPTED TO REMOVE CATHETER. |
16.
|
17.
BRAND NAME |
PERIFIX |
|||
TYPE OF DEVICE |
CESK TRAY |
|||
BASELINE BRAND NAME |
PERIFIX |
|||
BASELINE GENERIC NAME |
CUSTOM EPIDURAL TRAY |
|||
BASELINE CATALOGUE NUMBER |
555861 |
|||
BASELINE MODEL NUMBER |
CESK |
|||
BASELINE DEVICE FAMILY |
CONTINUOUS EPIDURAL TRAYS |
|||
BASELINE DEVICE 510(K) NUMBER |
K813186 |
|||
BASELINE SHELF LIFE INFORMATION |
YES |
|||
IS BASELINE PMA NUMBER PROVIDED?</< TH> |
NO |
|||
BASELINE PREAMENDMENT? |
NO |
|||
TRANSITIONAL? |
NO |
|||
510(K) EXEMPT? |
NO |
|||
SHELF LIFE(Months) |
12 |
|||
DATE FIRST MARKETED |
12/03/1981 |
|||
MANUFACTURER (Section D) |
|
|||
DEVICE EVENT KEY |
335851 |
|||
MDR REPORT KEY |
346535 |
|||
EVENT KEY |
326349 |
|||
REPORT NUMBER |
346535 |
|||
DEVICE SEQUENCE NUMBER |
1 |
|||
PRODUCT CODE |
CAZ |
|||
REPORT SOURCE |
USER FACILITY |
|||
TYPE OF REPORT |
INITIAL |
|||
REPORT DATE |
07/24/2001 |
|||
1 DEVICE WAS INVOLVED IN THE EVENT |
|
|||
1 PATIENT WAS INVOLVED IN THE EVENT |
|
|||
DATE FDA RECEIVED |
08/09/2001 |
|||
IS THIS AN ADVERSE EVENT REPORT? |
YES |
|||
IS THIS A PRODUCT PROBLEM REPORT? |
NO |
|||
DEVICE OPERATOR |
HEALTH PROFESSIONAL |
|||
DEVICE EXPIRATION DATE |
01/31/2001 |
|||
DEVICE MODEL NUMBER |
CESK |
|||
DEVICE CATALOGUE NUMBER |
555100 |
|||
DEVICE LOT NUMBER |
60063660 |
|||
WAS DEVICE AVAILABLE FOR EVALUATION? |
NO |
|||
IS THE REPORTER A HEALTH PROFESSIONAL? |
YES |
|||
WAS THE REPORT SENT TO FDA? |
NO |
|||
DISTRIBUTOR FACILITY AWARE DATE |
01/03/1999 |
|||
DEVICE AGE |
UNKNOWN |
|||
EVENT LOCATION |
HOSPITAL |
|||
PATIENT OUTCOME |
REQUIRED INTERVENTION |
ADVERSE EVENT OR PRODUCT PROBLEM DESCRIPTION |
REPORT DATE: 07/24/2001 MDR TEXT KEY: 1201504 Patient Sequence Number: 1 |
THE USER FACILITY REPORTS THE FOLLOWING: FAILED EPIDURAL INSERTION - A PIECE OF CATHETER BROKE OFF IN PT. UNABLE TO RETRIEVE CATHETER PART BROKEN OFF. |
18.
BRAND NAME |
PERIFIX |
||||
TYPE OF DEVICE |
CE TRAY |
||||
BASELINE BRAND NAME |
PERIFIX |
||||
BASELINE GENERIC NAME |
CONTINUOUS EPIDURAL TRAY |
||||
BASELINE CATALOGUE NUMBER |
332220 |
||||
BASELINE MODEL NUMBER |
CE18TK |
||||
BASELINE DEVICE FAMILY |
CONTINUOUS EPIDURAL KIT |
||||
BASELINE DEVICE 510(K) NUMBER |
K840179 |
||||
BASELINE SHELF LIFE INFORMATION |
YES |
||||
IS BASELINE PMA NUMBER PROVIDED?</< TH> |
NO |
||||
BASELINE PREAMENDMENT? |
NO |
||||
TRANSITIONAL? |
NO |
||||
510(K) EXEMPT? |
NO |
||||
SHELF LIFE(Months) |
12 |
||||
DATE FIRST MARKETED |
02/24/1984 |
||||
MANUFACTURER (Section F) |
|
||||
MANUFACTURER (Section D) |
|
||||
MANUFACTURER CONTACT |
|
||||
DEVICE EVENT KEY |
332367 |
||||
MDR REPORT KEY |
343032 |
||||
EVENT KEY |
323026 |
||||
REPORT NUMBER |
2523676-2001-00027 |
||||
DEVICE SEQUENCE NUMBER |
1 |
||||
PRODUCT CODE |
CAZ |
||||
REPORT SOURCE |
MANUFACTURER |
||||
SOURCE TYPE |
HEALTH PROFESSIONAL |
||||
REMEDIAL ACTION |
OTHER |
||||
EVENT TYPE |
INJURY |
||||
TYPE OF REPORT |
INITIAL |
||||
REPORT DATE |
07/12/2001,06/21/2001 |
||||
1 DEVICE WAS INVOLVED IN THE EVENT |
|
||||
1 PATIENT WAS INVOLVED IN THE EVENT |
|
||||
DATE FDA RECEIVED |
07/19/2001 |
||||
IS THIS AN ADVERSE EVENT REPORT? |
YES |
||||
IS THIS A PRODUCT PROBLEM REPORT? |
NO |
||||
DEVICE OPERATOR |
HEALTH PROFESSIONAL |
||||
DEVICE EXPIRATION DATE |
02/28/2003 |
||||
DEVICE MODEL NUMBER |
CE18TK |
||||
DEVICE CATALOGUE NUMBER |
332220 |
||||
WAS DEVICE AVAILABLE FOR EVALUATION? |
YES |
||||
IS THE REPORTER A HEALTH PROFESSIONAL? |
YES |
||||
WAS THE REPORT SENT TO FDA? |
NO |
||||
DISTRIBUTOR FACILITY AWARE DATE |
06/21/2001 |
||||
DEVICE AGE |
2 MO |
||||
EVENT LOCATION |
HOSPITAL |
||||
DATE MANUFACTURER RECEIVED |
06/21/2001 |
||||
WAS DEVICE EVALUATED BY MANUFACTURER? |
YES |
||||
DATE DEVICE MANUFACTURED |
05/01/2001 |
||||
IS THE DEVICE SINGLE USE? |
YES |
||||
TYPE OF DEVICE USAGE |
UNKNOWN |
||||
PATIENT OUTCOME |
REQUIRED INTERVENTION |
ADVERSE EVENT OR PRODUCT PROBLEM DESCRIPTION |
REPORT DATE: 07/12/2001 MDR TEXT KEY: 1188523 Patient Sequence Number: 1 |
THE USER FACILITY REPORTS THE FOLLOWING: CATHETER SHEARED LEAVING ABOUT 2 INCHES IN THE PT'S BACK. |
|
ADDITIONAL MANUFACTURER NARRATIVE |
REPORT DATE: 07/19/2001 MDR TEXT KEY: 1188526 |
THE RETURNED PORTION MEASURED APPROX 107CM IN LENGTH, WITH APPROXIMATE 7.5MM OF THE DISTAL TIP PORTION MISSING. THE CATHETER APPEARED STRETCHED AND ELONGATED WITH A REDUCTION IN THE OUTER DIAMETER, INDICATING THAT THE CATHETER HAD BECOME LODGED BETWEEN TWO RIGID BODY STRUCTURES AND STRETCHED BEYOND ITS INTENDED DESIGN CAPABILITIES. THIS OCCURRENCE DID NOT APPEAR TO BE THE RESULT OF ANY PRODUCT QUALITY DEFICIENCIES OR PRODUCT MALFUNCTION. IT SHOULD ALSO BE NOTED THAT THE LABELING ON THE TRAY STATES, "DO NOT WITHDRAWAL CATHETER THROUGH THE NEEDLE BECAUSE OF POSSIBLE DANGER OF SHEARING". |
19.
BRAND NAME |
PERIFIX |
||||
TYPE OF DEVICE |
CUSTOM TRAY |
||||
BASELINE BRAND NAME |
PERIFIX |
||||
BASELINE GENERIC NAME |
CUSTOM TRAY |
||||
BASELINE CATALOGUE NUMBER |
555311 |
||||
BASELINE MODEL NUMBER |
CESK-555311 |
||||
MANUFACTURER (Section F) |
|
||||
MANUFACTURER (Section D) |
|
||||
MANUFACTURER CONTACT |
|
||||
DEVICE EVENT KEY |
332372 |
||||
MDR REPORT KEY |
343037 |
||||
EVENT KEY |
323030 |
||||
REPORT NUMBER |
2523676-2001-00028 |
||||
DEVICE SEQUENCE NUMBER |
1 |
||||
PRODUCT CODE |
CAZ |
||||
REPORT SOURCE |
MANUFACTURER |
||||
SOURCE TYPE |
HEALTH PROFESSIONAL |
||||
REMEDIAL ACTION |
OTHER |
||||
EVENT TYPE |
INJURY |
||||
TYPE OF REPORT |
INITIAL |
||||
REPORT DATE |
07/18/2001 |
||||
1 DEVICE WAS INVOLVED IN THE EVENT |
|
||||
1 PATIENT WAS INVOLVED IN THE EVENT |
|
||||
DATE FDA RECEIVED |
07/19/2001 |
||||
IS THIS AN ADVERSE EVENT REPORT? |
YES |
||||
IS THIS A PRODUCT PROBLEM REPORT? |
NO |
||||
DEVICE OPERATOR |
HEALTH PROFESSIONAL |
||||
DEVICE MODEL NUMBER |
CESK-555311 |
||||
DEVICE CATALOGUE NUMBER |
555311 |
||||
WAS DEVICE AVAILABLE FOR EVALUATION? |
NO |
||||
IS THE REPORTER A HEALTH PROFESSIONAL? |
YES |
||||
WAS THE REPORT SENT TO FDA? |
NO |
||||
DISTRIBUTOR FACILITY AWARE DATE |
06/25/2001 |
||||
DEVICE AGE |
UNKNOWN |
||||
EVENT LOCATION |
HOSPITAL |
||||
DATE MANUFACTURER RECEIVED |
06/27/2001 |
||||
WAS DEVICE EVALUATED BY MANUFACTURER? |
DEVICE NOT RETURNED TO MANUFACTURER |
||||
IS THE DEVICE SINGLE USE? |
YES |
||||
TYPE OF DEVICE USAGE |
UNKNOWN |
||||
PATIENT OUTCOME |
REQUIRED INTERVENTION |
ADVERSE EVENT OR PRODUCT PROBLEM DESCRIPTION |
REPORT DATE: 07/18/2001 MDR TEXT KEY: 1188545 Patient Sequence Number: 1 |
PHYSICIAN REPORTING WHEN REMOVING CATHETER (20G CLOSED TIP), SOME RESISTANCE WAS MET, THE CATHETER STRETCHED, AND WHEN IT WAS REMOVED, THE CATHETER WAS NOT INTACT. ONE CM OF THE CATHETER BROKE AT THE DISTAL END WHEN REMOVING. PT IS "FINE" PER PHYSICIAN. |
|
ADDITIONAL MANUFACTURER NARRATIVE |
REPORT DATE: 07/19/2001 MDR TEXT KEY: 1188548 |
NO CONCLUSION CAN BE DRAWN SINCE THE PRODUCT WAS NOT RETURNED FOR EVALUATION. IT SHOULD BE NOTED THAT THE LABELING ON THE TRAY STATES, "DO NOT WITHDRAW CATHETER THROUGH THE NEEDLE BECAUSE OF POSSIBLE DANGER OF SHEARING". NO FURTHER INFO IS AVAILABLE ON THE PT'S STATUS. |
20.
BRAND NAME |
PERIFIX |
||||
TYPE OF DEVICE |
EPIDURAL CATHETER |
||||
BASELINE BRAND NAME |
PERIFIX |
||||
BASELINE GENERIC NAME |
CONTINUOUS EPIDURAL |
||||
BASELINE CATALOGUE NUMBER |
333521 |
||||
BASELINE MODEL NUMBER |
EC20CST |
||||
BASELINE DEVICE FAMILY |
CONTINUOUS EPIDURAL KITS |
||||
BASELINE DEVICE 510(K) NUMBER |
K840179 |
||||
BASELINE SHELF LIFE INFORMATION |
YES |
||||
IS BASELINE PMA NUMBER PROVIDED?</< TH> |
NO |
||||
BASELINE PREAMENDMENT? |
NO |
||||
TRANSITIONAL? |
NO |
||||
510(K) EXEMPT? |
NO |
||||
SHELF LIFE(Months) |
12 |
||||
DATE FIRST MARKETED |
02/24/1984 |
||||
MANUFACTURER (Section F) |
|
||||
MANUFACTURER (Section D) |
|
||||
MANUFACTURER CONTACT |
|
||||
DEVICE EVENT KEY |
326161 |
||||
MDR REPORT KEY |
336866 |
||||
EVENT KEY |
317047 |
||||
REPORT NUMBER |
2523676-2001-00017 |
||||
DEVICE SEQUENCE NUMBER |
1 |
||||
PRODUCT CODE |
CAZ |
||||
REPORT SOURCE |
MANUFACTURER |
||||
SOURCE TYPE |
USER FACILITY |
||||
REMEDIAL ACTION |
OTHER |
||||
EVENT TYPE |
INJURY |
||||
TYPE OF REPORT |
INITIAL |
||||
REPORT DATE |
05/23/2001 |
||||
1 DEVICE WAS INVOLVED IN THE EVENT |
|
||||
1 PATIENT WAS INVOLVED IN THE EVENT |
|
||||
DATE FDA RECEIVED |
06/08/2001 |
||||
IS THIS AN ADVERSE EVENT REPORT? |
YES |
||||
IS THIS A PRODUCT PROBLEM REPORT? |
NO |
||||
DEVICE OPERATOR |
HEALTH PROFESSIONAL |
||||
DEVICE MODEL NUMBER |
EC20CST |
||||
DEVICE CATALOGUE NUMBER |
333521 |
||||
WAS DEVICE AVAILABLE FOR EVALUATION? |
NO |
||||
IS THE REPORTER A HEALTH PROFESSIONAL? |
YES |
||||
WAS THE REPORT SENT TO FDA? |
NO |
||||
DISTRIBUTOR FACILITY AWARE DATE |
05/16/2001 |
||||
DEVICE AGE |
UNKNOWN |
||||
EVENT LOCATION |
HOSPITAL |
||||
DATE MANUFACTURER RECEIVED |
05/16/2001 |
||||
WAS DEVICE EVALUATED BY MANUFACTURER? |
NO |
||||
IS THE DEVICE SINGLE USE? |
YES |
||||
TYPE OF DEVICE USAGE |
INITIAL |
||||
PATIENT OUTCOME |
REQUIRED INTERVENTION |
ADVERSE EVENT OR PRODUCT PROBLEM DESCRIPTION |
REPORT DATE: 05/23/2001 MDR TEXT KEY: 1164607 Patient Sequence Number: 1 |
UPON REMOVAL OF THE EPIDURAL CATHETER THE NURSE EXPERIENCED RESISTANCE. THE ANESTHETIST WAS CALLED IN TO REMOVE THE CATHETER AND THE ANESTHETIST ALSO MET RESISTANCE, BUT WITHDREW THE CATHETER. THE TIP OF THE CATHETER WAS ABSENT WHEN REMOVED. THE USER/FACILITY WAS CONTACTED IN 2001 FOR ADDITIONAL INFORMATION. THE EPIDURAL WAS ADMINISTERED FOR LABOR AND DELIVERY. THE CATHETER WAS INSERTED EASILY, BUT WHEN REMOVED RESISTANCE WAS MET. A CT SCAN WAS PERFORMED AND THE TIP WAS NOT IN THE EPIDURAL SPACE, BUT IN THE SOFT TISSUE. THE PATIENT WAS RELEASED FROM THE HOSPITAL WITH NO ADVERSE EFFECTS. THE HOSPITAL'S RISK MANAGEMENT DEPARTMENT WILL NOT RELEASE THE SAMPLE FOR EVALUATION. |
|
ADDITIONAL MANUFACTURER NARRATIVE |
REPORT DATE: 05/23/2001 MDR TEXT KEY: 1164611 |
THE SAMPLE IS BEING RETAINED BY THE USER/FACILITY AND WILL NOT BE RELEASED. NO CONCLUSION CAN BE DRAWN SINCE THE DEVICE WAS NOT RETURNED FOR EVALUATION. THE PATIENT SUFFERED NO ADVERSE EFFECTS AS A RESULT OF THIS OCCURENCE. NO FURTHER INFORMATION IS AVAILABLE ON THE PATIENT STATUS. IT SHOULD ALSO BE NOTED THAT THE LABELING ON THE TRAY STATES, "DO NOT WITHDRAW CATHETER THROUGH THE NEEDLE BECAUSE OF POSSIBLE DANGER OF SHEARING". |
|
21.
BRAND NAME |
PERIFIX |
||||
TYPE OF DEVICE |
EPIDURAL CATHETER |
||||
BASELINE BRAND NAME |
PERIFIX |
||||
BASELINE GENERIC NAME |
CONTINUOUS EPIDURAL |
||||
BASELINE CATALOGUE NUMBER |
333520 |
||||
BASELINE MODEL NUMBER |
EC20-0 |
||||
BASELINE DEVICE FAMILY |
CONTINUOUS EPIDURAL KITS |
||||
BASELINE DEVICE 510(K) NUMBER |
K840179 |
||||
BASELINE SHELF LIFE INFORMATION |
YES |
||||
IS BASELINE PMA NUMBER PROVIDED?</< TH> |
NO |
||||
BASELINE PREAMENDMENT? |
NO |
||||
TRANSITIONAL? |
NO |
||||
510(K) EXEMPT? |
NO |
||||
SHELF LIFE(Months) |
12 |
||||
DATE FIRST MARKETED |
02/24/1984 |
||||
MANUFACTURER (Section F) |
|
||||
MANUFACTURER (Section D) |
|
||||
MANUFACTURER CONTACT |
|
||||
DEVICE EVENT KEY |
319314 |
||||
MDR REPORT KEY |
329950 |
||||
EVENT KEY |
310506 |
||||
REPORT NUMBER |
2523676-2001-00013 |
||||
DEVICE SEQUENCE NUMBER |
1 |
||||
PRODUCT CODE |
CAZ |
||||
REPORT SOURCE |
MANUFACTURER |
||||
SOURCE TYPE |
HEALTH PROFESSIONAL |
||||
REMEDIAL ACTION |
OTHER |
||||
EVENT TYPE |
INJURY |
||||
TYPE OF REPORT |
INITIAL |
||||
REPORT DATE |
04/02/2001 |
||||
1 DEVICE WAS INVOLVED IN THE EVENT |
|
||||
1 PATIENT WAS INVOLVED IN THE EVENT |
|
||||
DATE FDA RECEIVED |
04/26/2001 |
||||
IS THIS AN ADVERSE EVENT REPORT? |
YES |
||||
IS THIS A PRODUCT PROBLEM REPORT? |
NO |
||||
DEVICE OPERATOR |
HEALTH PROFESSIONAL |
||||
DEVICE EXPIRATION DATE |
02/01/2004 |
||||
DEVICE MODEL NUMBER |
EC20-0 |
||||
DEVICE CATALOGUE NUMBER |
333520 |
||||
DEVICE LOT NUMBER |
982990 |
||||
WAS DEVICE AVAILABLE FOR EVALUATION? |
NO |
||||
IS THE REPORTER A HEALTH PROFESSIONAL? |
YES |
||||
WAS THE REPORT SENT TO FDA? |
NO |
||||
DEVICE AGE |
2 YR |
||||
EVENT LOCATION |
HOSPITAL |
||||
DATE MANUFACTURER RECEIVED |
03/30/2001 |
||||
WAS DEVICE EVALUATED BY MANUFACTURER? |
DEVICE NOT RETURNED TO MANUFACTURER |
||||
DATE DEVICE MANUFACTURED |
02/01/1999 |
||||
IS THE DEVICE SINGLE USE? |
YES |
||||
TYPE OF DEVICE USAGE |
INITIAL |
||||
PATIENT OUTCOME |
REQUIRED INTERVENTION |
ADVERSE EVENT OR PRODUCT PROBLEM DESCRIPTION |
REPORT DATE: 04/02/2001 MDR TEXT KEY: 1138878 Patient Sequence Number: 1 |
MEDWATCH REPORT RECEIVED FROM USER/FACILITY STATES: "BLUE TIP NOT ON END OF EPIDURAL CATHETER AT THE TIME OF REMOVAL. X-RAY DID NOT LOCATE IT. PT WITHOUT NEUROLOGICAL DEFICITS." THE USER/FACILITY WAS CONTACTED ON 4/2001 FOR ADDITIONAL INFO. THE SAMPLE WAS INADVERTENTLY DISCARDED. THE PT WAS DISCHARGED WITH NO ADVERSE EFFECTS AS A RESULT OF THIS OCCURRENCE. NO ADDITIONAL INFO COULD BE PROVIDED. |
|
ADDITIONAL MANUFACTURER NARRATIVE |
REPORT DATE: 04/02/2001 MDR TEXT KEY: 1138881 |
NO CONCLUSION CAN BE DRAWN SINCE THE DEVICE WAS NOT RETURNED FOR EVAL. NO FURTHER INFO IS AVAILABLE ON THE PT'S STATUS. IT SHOULD BE NOTED THAT THE LABELING ON THE TRAY STATES, "DO NOT WITHDRAWAL CATHETER THROUGH THE NEEDLE BECAUSE OF POSSIBLE DANGER OF SHEARING". |
22.
BRAND NAME |
BRAUN PERIFIX |
||||
TYPE OF DEVICE |
EPIDURAL CATHETER |
||||
MANUFACTURER (Section D) |
|
||||
DEVICE EVENT KEY |
312646 |
||||
MDR REPORT KEY |
323181 |
||||
EVENT KEY |
304015 |
||||
REPORT NUMBER |
323181 |
||||
DEVICE SEQUENCE NUMBER |
1 |
||||
PRODUCT CODE |
BSO |
||||
REPORT SOURCE |
VOLUNTARY |
||||
REPORT DATE |
03/21/2001 |
||||
1 DEVICE WAS INVOLVED IN THE EVENT |
|
||||
1 PATIENT WAS INVOLVED IN THE EVENT |
|
||||
DATE FDA RECEIVED |
03/27/2001 |
||||
IS THIS AN ADVERSE EVENT REPORT? |
NO |
||||
IS THIS A PRODUCT PROBLEM REPORT? |
YES |
||||
DEVICE OPERATOR |
HEALTH PROFESSIONAL |
||||
DEVICE CATALOGUE NUMBER |
EC20-0-333520 |
||||
DEVICE LOT NUMBER |
9829902004-02 |
||||
WAS DEVICE AVAILABLE FOR EVALUATION? |
NO |
||||
PATIENT OUTCOME |
OTHER |
ADVERSE EVENT OR PRODUCT PROBLEM DESCRIPTION |
REPORT DATE: 03/21/2001 MDR TEXT KEY: 1114118 Patient Sequence Number: 1 |
BLUE TIP NOT ON END OF EPIDURAL CATHETER AT THE TIME OF REMOVAL. X-RAY DID NOT LOCATE IT. PT WITHOUT NEUROLOGIC DEFICITS. |
23.
BRAND NAME |
PERIFIX |
|||
TYPE OF DEVICE |
PERIFIX CONTINUOUS EPIDURAL CUSTOM TRAY |
|||
BASELINE BRAND NAME |
PERIFIX |
|||
BASELINE GENERIC NAME |
CUSTOM EPIDURAL TRAY |
|||
BASELINE CATALOGUE NUMBER |
555861 |
|||
BASELINE MODEL NUMBER |
CESK |
|||
BASELINE DEVICE FAMILY |
CONTINUOUS EPIDURAL TRAYS |
|||
BASELINE DEVICE 510(K) NUMBER |
K813186 |
|||
BASELINE SHELF LIFE INFORMATION |
YES |
|||
IS BASELINE PMA NUMBER PROVIDED?</< TH> |
NO |
|||
BASELINE PREAMENDMENT? |
NO |
|||
TRANSITIONAL? |
NO |
|||
510(K) EXEMPT? |
NO |
|||
SHELF LIFE(Months) |
12 |
|||
DATE FIRST MARKETED |
12/03/1981 |
|||
MANUFACTURER (Section D) |
|
|||
DEVICE EVENT KEY |
309578 |
|||
MDR REPORT KEY |
320053 |
|||
EVENT KEY |
300978 |
|||
REPORT NUMBER |
320053 |
|||
DEVICE SEQUENCE NUMBER |
1 |
|||
PRODUCT CODE |
CAZ |
|||
REPORT SOURCE |
USER FACILITY |
|||
TYPE OF REPORT |
INITIAL |
|||
REPORT DATE |
02/28/2001 |
|||
1 DEVICE WAS INVOLVED IN THE EVENT |
|
|||
1 PATIENT WAS INVOLVED IN THE EVENT |
|
|||
DATE FDA RECEIVED |
03/09/2001 |
|||
IS THIS AN ADVERSE EVENT REPORT? |
YES |
|||
IS THIS A PRODUCT PROBLEM REPORT? |
NO |
|||
DEVICE OPERATOR |
HEALTH PROFESSIONAL |
|||
DEVICE MODEL NUMBER |
CESK |
|||
DEVICE CATALOGUE NUMBER |
555175 |
|||
WAS DEVICE AVAILABLE FOR EVALUATION? |
NO |
|||
IS THE REPORTER A HEALTH PROFESSIONAL? |
YES |
|||
WAS THE REPORT SENT TO FDA? |
NO |
|||
DISTRIBUTOR FACILITY AWARE DATE |
02/08/2001 |
|||
DEVICE AGE |
UNKNOWN |
|||
EVENT LOCATION |
HOSPITAL |
|||
DATE REPORT TO MANUFACTURER |
02/06/2001 |
|||
PATIENT OUTCOME |
REQUIRED INTERVENTION |
ADVERSE EVENT OR PRODUCT PROBLEM DESCRIPTION |
REPORT DATE: 02/28/2001 MDR TEXT KEY: 1103228 Patient Sequence Number: 1 |
DURING PLACEMENT OF THE EPIDURAL CATHETER FOR A C-SECTION THE PHYSICIAN ADVANCED THE CATHETER APROXIMATELY 1 TO 2 CM WHEN RESISTANCE WAS MET. THE CATHETER WAS PULLED BACK AND A PORTION OF THE TIP WAS MISSING; APPROXIMATELY 1/2 CM. THE CATHETER TIP REMAINS IN THE PT. THE USER/FACILITY WAS CONTACTED ON 2/9/01 FOR ADDITIONAL INFORMATION. THE SAMPLE WAS DISCARDED AND THE LOT NUMBER COULD NOT BE DETERMINED. THE PT SUFFERED NO ADVERSE EFFECTS AS A RESULT OF THIS OCCURRENCE. NO ADDITIONAL INFORMATION COULD BE PROVIDED. RECEIVED MEDWATCH REPORT ON 2/23/01 FROM USER/FACILITY STATING: "DURING EPIDURAL CATH PLACEMENT, MD MET RESISTANCE, PULLED BACK ON CATHETER. BLUE CATH TIP TO SHEAR OFF INTO EPIDURAL SPACE." |
|
24.
BRAND NAME |
PERIFIX |
||||
TYPE OF DEVICE |
EPIDURAL CATHETER |
||||
BASELINE BRAND NAME |
PERIFIX |
||||
BASELINE GENERIC NAME |
EPIDURAL CATHETER |
||||
BASELINE CATALOGUE NUMBER |
UNK EPIDURAL CATH. |
||||
BASELINE MODEL NUMBER |
UNK |
||||
MANUFACTURER (Section F) |
|
||||
MANUFACTURER (Section D) |
|
||||
MANUFACTURER CONTACT |
|
||||
DEVICE EVENT KEY |
301077 |
||||
MDR REPORT KEY |
311270 |
||||
EVENT KEY |
292565 |
||||
REPORT NUMBER |
2523676-2000-00050 |
||||
DEVICE SEQUENCE NUMBER |
1 |
||||
PRODUCT CODE |
BSO |
||||
REPORT SOURCE |
MANUFACTURER |
||||
SOURCE TYPE |
USER FACILITY |
||||
REMEDIAL ACTION |
OTHER |
||||
EVENT TYPE |
INJURY |
||||
TYPE OF REPORT |
INITIAL |
||||
REPORT DATE |
12/15/2000 |
||||
1 DEVICE WAS INVOLVED IN THE EVENT |
|
||||
1 PATIENT WAS INVOLVED IN THE EVENT |
|
||||
DATE FDA RECEIVED |
01/05/2001 |
||||
IS THIS AN ADVERSE EVENT REPORT? |
YES |
||||
IS THIS A PRODUCT PROBLEM REPORT? |
NO |
||||
DEVICE OPERATOR |
HEALTH PROFESSIONAL |
||||
DEVICE CATALOGUE NUMBER |
UNK EPIDURAL CATH. |
||||
WAS DEVICE AVAILABLE FOR EVALUATION? |
NO |
||||
IS THE REPORTER A HEALTH PROFESSIONAL? |
YES |
||||
WAS THE REPORT SENT TO FDA? |
NO |
||||
DISTRIBUTOR FACILITY AWARE DATE |
12/06/2000 |
||||
DEVICE AGE |
UNKNOWN |
||||
EVENT LOCATION |
HOSPITAL |
||||
DATE MANUFACTURER RECEIVED |
12/06/2000 |
||||
WAS DEVICE EVALUATED BY MANUFACTURER? |
DEVICE NOT RETURNED TO MANUFACTURER |
||||
IS THE DEVICE SINGLE USE? |
YES |
||||
TYPE OF DEVICE USAGE |
INITIAL |
||||
PATIENT OUTCOME |
REQUIRED INTERVENTION |
ADVERSE EVENT OR PRODUCT PROBLEM DESCRIPTION |
REPORT DATE: 12/15/2000 MDR TEXT KEY: 1072341 Patient Sequence Number: 1 |
THE FACILITY/USER STATES: "WHEN NURSE REMOVED EPIDURAL CATHETER, 1-2CM AT TIP WAS MISSING. UNABLE TO SEE ON X-RAY." A FOLLOW-UP CALL WAS MADE ON 1/4/01. ADDITIONAL INFORMATION OBTAINED FROM THE USER/FACILITY INDICATED THAT THE PHYSICIAN FELT HE PULLED THE CATHETER A LITTLE HARDER THAN HE SHOULD HAVE. THE PT SUFFERED NO ADVERSE EFFECTS AS A RESULT OF THIS OCCURRENCE. THE LOT NUMBER AND CATALOG NUMBER COULD NOT BE DETERMINED. |
|
ADDITIONAL MANUFACTURER NARRATIVE |
REPORT DATE: 12/15/2000 MDR TEXT KEY: 1072344 |
THE INFORMATION PROVIDED BY THE USER/FACILITY, SUGGESTS THAT THE CATHETER HAD BECOME LODGED BETWEEN TWO RIGID BODY STRUCTURES, AND STRETECHED BEYOND IT'S INTENDED DESIGN CAPABILITIES DURING REMOVAL. THIS OCCURRENCE DID NOT APPEAR TO BE THE RESULT OF ANY PRODUCT QUALITY DEFICIENCIES OR PRODUCT MALFUNCTION. THE FACILITY'S RISK MANAGEMENT DEPARTMENT WILL NOT RELEASE THE SAMPLE FOR EVAL. IN THE ABSENCE OF A RETURNED SAMPLE, NO SPECIFIC CONCLUSIONS CAN BE DRAWN. THE PT SUFFERED NO ADVERSE EFFECTS AS A RESULT OF THIS OCCURRENCE. IT SHOULD ALSO BE NOTED THAT THE LABELING ON THE TRAY STATES, "DO NOT WITHDRAWAL CATHETER THROUGH THE NEEDLE BECAUSE OF POSSIBLE DANGER OF SHEARING". |
|
25.
BRAND NAME |
PERIFIX |
||||
TYPE OF DEVICE |
EPIDURAL CATHETER |
||||
BASELINE BRAND NAME |
PERIFIX |
||||
BASELINE GENERIC NAME |
EPIDURAL CATHETER |
||||
BASELINE CATALOGUE NUMBER |
UNK EPIDURAL CATH. |
||||
BASELINE MODEL NUMBER |
UNK |
||||
MANUFACTURER (Section F) |
|
||||
MANUFACTURER (Section D) |
|
||||
MANUFACTURER CONTACT |
|
||||
DEVICE EVENT KEY |
300398 |
||||
MDR REPORT KEY |
310511 |
||||
EVENT KEY |
291848 |
||||
REPORT NUMBER |
2523676-2000-00058 |
||||
DEVICE SEQUENCE NUMBER |
1 |
||||
PRODUCT CODE |
BSO |
||||
REPORT SOURCE |
MANUFACTURER |
||||
SOURCE TYPE |
USER FACILITY |
||||
REMEDIAL ACTION |
OTHER |
||||
EVENT TYPE |
INJURY |
||||
TYPE OF REPORT |
INITIAL |
||||
REPORT DATE |
12/19/2000 |
||||
1 DEVICE WAS INVOLVED IN THE EVENT |
|
||||
1 PATIENT WAS INVOLVED IN THE EVENT |
|
||||
DATE FDA RECEIVED |
12/27/2000 |
||||
IS THIS AN ADVERSE EVENT REPORT? |
YES |
||||
IS THIS A PRODUCT PROBLEM REPORT? |
NO |
||||
DEVICE OPERATOR |
HEALTH PROFESSIONAL |
||||
DEVICE CATALOGUE NUMBER |
UNK EPIDURAL CATH. |
||||
WAS DEVICE AVAILABLE FOR EVALUATION? |
NO |
||||
IS THE REPORTER A HEALTH PROFESSIONAL? |
YES |
||||
WAS THE REPORT SENT TO FDA? |
NO |
||||
DISTRIBUTOR FACILITY AWARE DATE |
12/19/2000 |
||||
DEVICE AGE |
UNKNOWN |
||||
EVENT LOCATION |
HOSPITAL |
||||
DATE MANUFACTURER RECEIVED |
12/13/2000 |
||||
WAS DEVICE EVALUATED BY MANUFACTURER? |
DEVICE NOT RETURNED TO MANUFACTURER |
||||
IS THE DEVICE SINGLE USE? |
YES |
||||
TYPE OF DEVICE USAGE |
INITIAL |
||||
PATIENT OUTCOME |
OTHER |
ADDITIONAL MANUFACTURER NARRATIVE |
REPORT DATE: 12/19/2000 MDR TEXT KEY: 1069546 |
NO CONCLUSION CAN BE DRAWN SINCE THE PRODUCT WAS NOT RETURNED FOR EVAL. NO FURTHER INFORMATION IS AVAILABLE ON THE PT'S STATUS. IT SHOULD ALSO BE NOTED THAT THE LABELING ON THE TRAY STATES, "DO NOT WITHDRAW CATHETER THROUGH THE NEEDLE BECAUSE OF POSSIBLE DANGER OF SHEARING". |
|
ADVERSE EVENT OR PRODUCT PROBLEM DESCRIPTION |
REPORT DATE: 12/19/2000 MDR TEXT KEY: 1069601 Patient Sequence Number: 1 |
MEDWATCH FROM USER/FACILITY STATES: IN 2000 THE PT HAD A LAMINECTOMY, SPINAL FUSION AND INSERTION OF AN EPIDURAL (PERIFIX) CATHETER. IN 3 DAYS LATER, WHEN THE ANESTHETIST WAS TRYING TO REMOVE THE EPIDURAL CATHETER FROM THE PT, THE CATHETER BROKE AND APPROX 8 INCHES REMAINED IN THE WOUND." A FOLLOW-UP CALL WAS MADE 17 DAYS FOLLOWING LAMINECTOMY. ADDITIONAL INFORMATION OBTAINED FROM THE USER/FACILITY INDICATED THAT THE ANESTHESIOLOGIST FELT MODERATE RESISTANCE UPON REMOVAL. THE SAMPLE WAS DISCARDED. THE LOT NUMBER AND THE CATALOG NUMBER COULD NOT BE PROVIDED. THE PT IS IN REHABILITATION AND SUFFERED NO ADVERSE EFFECTS AS A RESULT OF THIS OCCURRENCE. |
26.
BRAND NAME |
PERIFIX CONTINUOUS EPIDURAL ANESTHESIA SET |
|||
TYPE OF DEVICE |
EPIDURAL CATHETER |
|||
MANUFACTURER (Section D) |
|
|||
DEVICE EVENT KEY |
299388 |
|||
MDR REPORT KEY |
309434 |
|||
EVENT KEY |
290827 |
|||
REPORT NUMBER |
309434 |
|||
DEVICE SEQUENCE NUMBER |
1 |
|||
PRODUCT CODE |
CAZ |
|||
REPORT SOURCE |
VOLUNTARY |
|||
REPORT DATE |
12/12/2000 |
|||
1 DEVICE WAS INVOLVED IN THE EVENT |
|
|||
1 PATIENT WAS INVOLVED IN THE EVENT |
|
|||
DATE FDA RECEIVED |
12/19/2000 |
|||
IS THIS AN ADVERSE EVENT REPORT? |
NO |
|||
DEVICE OPERATOR |
HEALTH PROFESSIONAL |
|||
WAS DEVICE AVAILABLE FOR EVALUATION? |
NO |
|||
PATIENT OUTCOME |
OTHER |
ADVERSE EVENT OR PRODUCT PROBLEM DESCRIPTION |
REPORT DATE: 12/12/2000 MDR TEXT KEY: 1065633 Patient Sequence Number: 1 |
THE PT HAD A LAMINECTOMY, SPINAL FUSION AND INSERTION OF AN EPIDURAL (PERIFIX) CATHETER. WHEN THE ANESTHETIST WAS TRYING TO REMOVE THE EPIDURAL CATHETER FROM THE PT, THE CATHETER BROKE AND APPROX 8 INCHES REMAINED IN THE WOUND. |
27.
BRAND NAME |
PERIFIX |
||||
TYPE OF DEVICE |
ESPOCAN COMBINED SPINAL/EPIDURAL ANESTHESIA SET |
||||
BASELINE BRAND NAME |
PERIFIX |
||||
BASELINE GENERIC NAME |
CONTINUOUS EPIDURAL |
||||
BASELINE CATALOGUE NUMBER |
333192 |
||||
BASELINE MODEL NUMBER |
ES1827K |
||||
BASELINE DEVICE FAMILY |
CONTINUOUS EPIDURAL KITS |
||||
BASELINE DEVICE 510(K) NUMBER |
K840179 |
||||
BASELINE SHELF LIFE INFORMATION |
YES |
||||
IS BASELINE PMA NUMBER PROVIDED?</< TH> |
NO |
||||
BASELINE PREAMENDMENT? |
NO |
||||
TRANSITIONAL? |
NO |
||||
510(K) EXEMPT? |
NO |
||||
SHELF LIFE(Months) |
12 |
||||
DATE FIRST MARKETED |
02/24/1984 |
||||
MANUFACTURER (Section F) |
|
||||
MANUFACTURER (Section D) |
|
||||
MANUFACTURER CONTACT |
|
||||
DEVICE EVENT KEY |
293980 |
||||
MDR REPORT KEY |
303766 |
||||
EVENT KEY |
285458 |
||||
REPORT NUMBER |
2523676-2000-00045 |
||||
DEVICE SEQUENCE NUMBER |
1 |
||||
PRODUCT CODE |
CAZ |
||||
REPORT SOURCE |
MANUFACTURER |
||||
SOURCE TYPE |
USER FACILITY |
||||
REMEDIAL ACTION |
OTHER |
||||
EVENT TYPE |
INJURY |
||||
TYPE OF REPORT |
INITIAL,FOLLOWUP |
||||
REPORT DATE |
10/17/2000 |
||||
1 DEVICE WAS INVOLVED IN THE EVENT |
|
||||
1 PATIENT WAS INVOLVED IN THE EVENT |
|
||||
DATE FDA RECEIVED |
11/03/2000 |
||||
IS THIS AN ADVERSE EVENT REPORT? |
YES |
||||
IS THIS A PRODUCT PROBLEM REPORT? |
NO |
||||
DEVICE OPERATOR |
HEALTH PROFESSIONAL |
||||
DEVICE EXPIRATION DATE |
02/28/2003 |
||||
DEVICE MODEL NUMBER |
ES1827K |
||||
DEVICE CATALOGUE NUMBER |
333192 |
||||
DEVICE LOT NUMBER |
60117793 |
||||
WAS DEVICE AVAILABLE FOR EVALUATION? |
YES |
||||
IS THE REPORTER A HEALTH PROFESSIONAL? |
YES |
||||
WAS THE REPORT SENT TO FDA? |
YES |
||||
DISTRIBUTOR FACILITY AWARE DATE |
10/04/2000 |
||||
DEVICE AGE |
4 MO |
||||
EVENT LOCATION |
HOSPITAL |
||||
DATE MANUFACTURER RECEIVED |
10/04/2000 |
||||
WAS DEVICE EVALUATED BY MANUFACTURER? |
DEVICE NOT RETURNED TO MANUFACTURER |
||||
IS THE DEVICE SINGLE USE? |
YES |
||||
TYPE OF DEVICE USAGE |
INITIAL |
||||
PATIENT OUTCOME |
REQUIRED INTERVENTION |
ADVERSE EVENT OR PRODUCT PROBLEM DESCRIPTION |
REPORT DATE: 10/17/2000 MDR TEXT KEY: 1044914 Patient Sequence Number: 1 |
UPON REMOVAL OF EPIDURAL CATHETER, BLUE TIP WAS MISSING. NO RESISTANCE WAS NOTED WHEN REMOVED. |
|
ADDITIONAL MANUFACTURER NARRATIVE |
REPORT DATE: 10/17/2000 MDR TEXT KEY: 1044917 |
THE SAMPLE HAS BEEN REQUESTED FROM THE USER FACILITY, BUT HAS NOT YET BEEN RECEIVED; THEREFORE, NO CONCLUSION CAN BE DRAWN. A FOLLOW-UP WILL BE FILED IF MORE INFO BECOMES AVAILABLE. NO FURTHER INFO IS AVAILABLE ON THE PT'S STATUS. IT SHOULD BE NOTED THAT THE LABELING ON THE TRAY STATES, "DO NOT WITHDRAWAL CATHETER THROUGH THE NEEDLE BECAUSE OF POSSIBLE DANGER OF SHEARING". |
|
ADVERSE EVENT OR PRODUCT PROBLEM DESCRIPTION |
REPORT DATE: 10/17/2000 MDR TEXT KEY: 1147687 Patient Sequence Number: 1 |
UPON REMOVAL OF EPIDURAL CATHETER, BLUE TIP WAS MISSING. NO RESISTANCE WAS NOTED WHEN REMOVED. |
|
ADDITIONAL MANUFACTURER NARRATIVE |
REPORT DATE: 10/17/2000 MDR TEXT KEY: 1147690 |
FOLLOW UP #1: THE SAMPLE WAS RECEIVED ON 11/15/00. THE RETURNED PORTION MEASURED APPROX 107 CM IN LENGTH, WITH THE DISTAL TIP PORTION MISSING. THE CATHETER APPEARED STRETCHED AND ELONGATED WITH A REDUCTION IN THE OUTER DIAMETER, INDICATING THAT THE CATHETER HAD BECOME LEDGED BETWEEN TWO RIGID BODY STRUCTURES AND STRETCHED BEYOND ITS INTENDED DESIGN CAPABILITIES. THIS OCCURRENCE DID NOT APPEAR TO BE THE RESULT OF ANY PRODUCT QUALITY DEFICIENCIES OR PRODUCT MALFUNCTION. |
28.
BRAND NAME |
PERIFIX |
||||
BASELINE BRAND NAME |
PERIFIX |
||||
BASELINE GENERIC NAME |
* |
||||
BASELINE CATALOGUE NUMBER |
333521 |
||||
MANUFACTURER (Section F) |
|
||||
MANUFACTURER (Section D) |
|
||||
MANUFACTURER CONTACT |
|
||||
DEVICE EVENT KEY |
293986 |
||||
MDR REPORT KEY |
303772 |
||||
EVENT KEY |
285464 |
||||
REPORT NUMBER |
2523676-2000-00019 |
||||
DEVICE SEQUENCE NUMBER |
1 |
||||
PRODUCT CODE |
CAZ |
||||
REPORT SOURCE |
MANUFACTURER |
||||
SOURCE TYPE |
USER FACILITY |
||||
REMEDIAL ACTION |
OTHER |
||||
EVENT TYPE |
INJURY |
||||
TYPE OF REPORT |
INITIAL |
||||
REPORT DATE |
10/13/2000 |
||||
1 DEVICE WAS INVOLVED IN THE EVENT |
|
||||
1 PATIENT WAS INVOLVED IN THE EVENT |
|
||||
DATE FDA RECEIVED |
11/03/2000 |
||||
IS THIS AN ADVERSE EVENT REPORT? |
YES |
||||
IS THIS A PRODUCT PROBLEM REPORT? |
NO |
||||
DEVICE OPERATOR |
INVALID DATA |
||||
DEVICE CATALOGUE NUMBER |
333521 |
||||
WAS DEVICE AVAILABLE FOR EVALUATION? |
NO |
||||
IS THE REPORTER A HEALTH PROFESSIONAL? |
YES |
||||
WAS THE REPORT SENT TO FDA? |
NO |
||||
DISTRIBUTOR FACILITY AWARE DATE |
10/05/2000 |
||||
DEVICE AGE |
UNKNOWN |
||||
EVENT LOCATION |
HOSPITAL |
||||
DATE MANUFACTURER RECEIVED |
10/05/2000 |
||||
WAS DEVICE EVALUATED BY MANUFACTURER? |
DEVICE NOT RETURNED TO MANUFACTURER |
||||
IS THE DEVICE SINGLE USE? |
YES |
||||
TYPE OF DEVICE USAGE |
INITIAL |
ADVERSE EVENT OR PRODUCT PROBLEM DESCRIPTION |
REPORT DATE: 10/13/2000 MDR TEXT KEY: 1044938 Patient Sequence Number: 1 |
DISTAL TIP OF SOFT TIP CATHETER WAS ABSENT UPON REMOVAL OF CATHETER. DR PERFORMED THE PLACEMENT OF THE CATHETER. THE SAMPLE WILL NOT BE RETURNED; HOWEVER, A PHOTO WAS SUPPLIED. NO FURTHER INFO COULD BE OBTAINED. |
|
ADDITIONAL MANUFACTURER NARRATIVE |
REPORT DATE: 11/03/2000 MDR TEXT KEY: 1044941 |
THE DEVICE IS NOT BEING RETURNED FOR EVALUATION; ALTHOUGH A PHOTO WAS SUPPLIED. THE SHAPE OF THE CATHETER IN THE PHOTO GIVES THE APPEARANCE THE SAMPLE WAS STRETCHED AND ELONGATED. THE IMAGE OF THE PHOTO SUGGESTS THAT THE CATHETER HAD BECOME LODGED BETWEEN TWO RIGID BODY STRUCTURES, AND STRETCHED BEYOND ITS INTENDED DESIGN CAPABILITIES DURING REMOVAL. HOWEVER, SINCE THE SAMPLE WAS NOT RETURNED NO CONCLUSION CAN BE DRAWN. NO FURTHER INFO IS AVAILABLE ON THE PT'S STATUS. IT SHOULD BE NOTED THAT THE LABELING ON THE TRAY STATES, "DO NOT WITHDRAWAL CATHETER THROUG THE NEEDLE BECAUSE OF POSSIBLE DANGER OF SHEARING". |
|
29.
BRAND NAME |
PERIFIX |
||||
TYPE OF DEVICE |
CONTINUOUS EPIDURAL TRY W/18G X 3 1/2 HUSTEAD |
||||
BASELINE BRAND NAME |
PERIFIX |
||||
BASELINE GENERIC NAME |
CONTINUOUS EPIDURAL |
||||
BASELINE CATALOGUE NUMBER |
332084 |
||||
BASELINE MODEL NUMBER |
CE18HKST |
||||
BASELINE DEVICE FAMILY |
CONTINUOUS EPIDURAL KITS |
||||
BASELINE DEVICE 510(K) NUMBER |
K840179 |
||||
BASELINE SHELF LIFE INFORMATION |
YES |
||||
IS BASELINE PMA NUMBER PROVIDED?</< TH> |
NO |
||||
BASELINE PREAMENDMENT? |
NO |
||||
TRANSITIONAL? |
NO |
||||
510(K) EXEMPT? |
NO |
||||
SHELF LIFE(Months) |
12 |
||||
DATE FIRST MARKETED |
02/24/1994 |
||||
MANUFACTURER (Section F) |
|
||||
MANUFACTURER (Section D) |
|
||||
MANUFACTURER CONTACT |
|
||||
DEVICE EVENT KEY |
292111 |
||||
MDR REPORT KEY |
301808 |
||||
EVENT KEY |
283553 |
||||
REPORT NUMBER |
2523676-2000-00042 |
||||
DEVICE SEQUENCE NUMBER |
1 |
||||
PRODUCT CODE |
CAZ |
||||
REPORT SOURCE |
MANUFACTURER |
||||
SOURCE TYPE |
USER FACILITY |
||||
REMEDIAL ACTION |
OTHER |
||||
EVENT TYPE |
INJURY |
||||
TYPE OF REPORT |
INITIAL,FOLLOWUP |
||||
REPORT DATE |
09/28/2000,09/26/2000 |
||||
1 DEVICE WAS INVOLVED IN THE EVENT |
|
||||
1 PATIENT WAS INVOLVED IN THE EVENT |
|
||||
DATE FDA RECEIVED |
10/24/2000 |
||||
IS THIS AN ADVERSE EVENT REPORT? |
YES |
||||
IS THIS A PRODUCT PROBLEM REPORT? |
NO |
||||
DEVICE OPERATOR |
HEALTH PROFESSIONAL |
||||
DEVICE EXPIRATION DATE |
02/28/2003 |
||||
DEVICE MODEL NUMBER |
CE18HKST |
||||
DEVICE CATALOGUE NUMBER |
332084 |
||||
DEVICE LOT NUMBER |
60125694 |
||||
WAS DEVICE AVAILABLE FOR EVALUATION? |
NO ANSWER PROVIDED |
||||
IS THE REPORTER A HEALTH PROFESSIONAL? |
YES |
||||
WAS THE REPORT SENT TO FDA? |
NO |
||||
DISTRIBUTOR FACILITY AWARE DATE |
09/26/2000 |
||||
DEVICE AGE |
UNKNOWN |
||||
EVENT LOCATION |
HOSPITAL |
||||
DATE MANUFACTURER RECEIVED |
09/26/2000 |
||||
WAS DEVICE EVALUATED BY MANUFACTURER? |
DEVICE NOT RETURNED TO MANUFACTURER |
||||
DATE DEVICE MANUFACTURED |
07/01/2000 |
||||
IS THE DEVICE SINGLE USE? |
YES |
||||
TYPE OF DEVICE USAGE |
UNKNOWN |
||||
PATIENT OUTCOME |
REQUIRED INTERVENTION |
ADVERSE EVENT OR PRODUCT PROBLEM DESCRIPTION |
REPORT DATE: 09/28/2000 MDR TEXT KEY: 1037046 Patient Sequence Number: 1 |
PT WAS POST-OP WITH AN EPIDURAL FOR PAIN CONTROL. THE CATHETER WAS INSERTED IN 2000. IT WAS DISCONTINUED AND REMOVED BY AN RN 5 DAYS LATER. UPON REMOVAL, THE RN INSPECTED THE CATHETER AND NOTICED THAT THE BLUE TIP OF EPIDURAL CATHETER WAS MISSING. THE PHYSICIAN DID NOT ATTEMPT REMOVAL. THE PT WAS INFORMED. |
|
ADDITIONAL MANUFACTURER NARRATIVE |
REPORT DATE: 09/28/2000 MDR TEXT KEY: 1037049 |
NO CONCLUSION CAN BE DRAWN SINCE THE SAMPLE WAS NOT RETURNED. THIS REPORT WILL BE RE-OPENED IF THE SAMPLE OR ADD'L INFO BECOMES AVAILABLE. IT SHOULD ALSO BE NOTED THAT THE LABELING ON THE TRAY STATES, "DO NOT WITHDRAW CATHETER THROUGH THE NEEDLE BECAUSE OF POSSIBLE DANGER OF SHEARING". NO FURTHER INFO IS AVAILABLE ON THE PT'S STATUS. |
|
ADDITIONAL MANUFACTURER NARRATIVE |
REPORT DATE: 09/28/2000 MDR TEXT KEY: 1135016 |
THE SAMPLE WAS RECEIVED. THE BLUE TIP OF THE CATHETER WAS MISSING. THERE WAS NOT ENOUGH INFORMATION PROVIDED TO SPECIFICALLY DETERMINE HOW THE SEPARATION OCCURRED; HOWEVER, PREVIOUS INVESTIGATIONS OF THIS NATURE HAVE SHOWN THAT SEVERAL FORCES MAY INTERACT TO CAUSE OCCURRENCES OF THIS TYPE. THE POSITION OF THE CATHETER BETWEEN VERTEBRAE OR LIGAMENTS WITHIN THE PT'S BACK, LENGTH OF TIME IN VIVO, TENSILE FORCEPS APPLIED TO THE CATHETER DURING REMOVAL, OR CATHETER WITHDRAWAL THROUGH THE EPIDURAL NEEDLE ARE ALL FACTORS WHICH, IN COMBINATION OR ALONE MAY RESULT IN THIS TYPE OF OCCURRENCE. |
30.
BRAND NAME |
PERIFIX - CE 18 HKST |
||
TYPE OF DEVICE |
EPIDURAL CATHETER |
||
MANUFACTURER (Section F) |
|
||
MANUFACTURER (Section D) |
|
||
DEVICE EVENT KEY |
289992 |
||
MDR REPORT KEY |
299596 |
||
EVENT KEY |
281459 |
||
REPORT NUMBER |
299596 |
||
DEVICE SEQUENCE NUMBER |
1 |
||
PRODUCT CODE |
BSO |
||
REPORT SOURCE |
USER FACILITY |
||
TYPE OF REPORT |
INITIAL |
||
REPORT DATE |
10/05/2000 |
||
1 DEVICE WAS INVOLVED IN THE EVENT |
|
||
1 PATIENT WAS INVOLVED IN THE EVENT |
|
||
DATE FDA RECEIVED |
10/06/2000 |
||
IS THIS AN ADVERSE EVENT REPORT? |
NO |
||
IS THIS A PRODUCT PROBLEM REPORT? |
YES |
||
DEVICE OPERATOR |
HEALTH PROFESSIONAL |
||
DEVICE EXPIRATION DATE |
02/01/2003 |
||
DEVICE MODEL NUMBER |
CE18 HKST |
||
DEVICE CATALOGUE NUMBER |
332084 |
||
DEVICE LOT NUMBER |
60125694 |
||
WAS DEVICE AVAILABLE FOR EVALUATION? |
YES |
||
IS THE REPORTER A HEALTH PROFESSIONAL? |
NO |
||
WAS THE REPORT SENT TO FDA? |
NO |
||
DISTRIBUTOR FACILITY AWARE DATE |
09/26/2000 |
||
EVENT LOCATION |
HOSPITAL |
||
PATIENT OUTCOME |
OTHER |
ADVERSE EVENT OR PRODUCT PROBLEM DESCRIPTION |
REPORT DATE: 10/05/2000 MDR TEXT KEY: 1029048 Patient Sequence Number: 1 |
UPON INSPECTION, BLUE TIP OF EPIDURAL CATHETER MISSING WHEN CATHETER REMOVED. |
31.
BRAND NAME |
PERIFIX |
||||
TYPE OF DEVICE |
PERIFIX CONTINUOUS EPIDURAL TRAY |
||||
BASELINE BRAND NAME |
PERIFIX |
||||
BASELINE GENERIC NAME |
EPIDURAL CATHETER |
||||
BASELINE CATALOGUE NUMBER |
332221 |
||||
BASELINE MODEL NUMBER |
CE17TK |
||||
BASELINE DEVICE FAMILY |
EPIDURAL CATHETER |
||||
BASELINE DEVICE 510(K) NUMBER |
K840179 |
||||
BASELINE SHELF LIFE INFORMATION |
YES |
||||
IS BASELINE PMA NUMBER PROVIDED?</< TH> |
NO |
||||
BASELINE PREAMENDMENT? |
NO |
||||
TRANSITIONAL? |
NO |
||||
510(K) EXEMPT? |
NO |
||||
SHELF LIFE(Months) |
12 |
||||
DATE FIRST MARKETED |
02/24/1984 |
||||
MANUFACTURER (Section F) |
|
||||
MANUFACTURER (Section D) |
|
||||
MANUFACTURER CONTACT |
|
||||
DEVICE EVENT KEY |
285700 |
||||
MDR REPORT KEY |
295171 |
||||
EVENT KEY |
277208 |
||||
REPORT NUMBER |
2523676-2000-00022 |
||||
DEVICE SEQUENCE NUMBER |
1 |
||||
PRODUCT CODE |
CAZ |
||||
REPORT SOURCE |
MANUFACTURER |
||||
SOURCE TYPE |
HEALTH PROFESSIONAL |
||||
REMEDIAL ACTION |
OTHER |
||||
EVENT TYPE |
INJURY |
||||
TYPE OF REPORT |
INITIAL |
||||
REPORT DATE |
09/01/2000 |
||||
1 DEVICE WAS INVOLVED IN THE EVENT |
|
||||
1 PATIENT WAS INVOLVED IN THE EVENT |
|
||||
DATE FDA RECEIVED |
09/08/2000 |
||||
IS THIS AN ADVERSE EVENT REPORT? |
YES |
||||
IS THIS A PRODUCT PROBLEM REPORT? |
NO |
||||
DEVICE OPERATOR |
HEALTH PROFESSIONAL |
||||
DEVICE EXPIRATION DATE |
11/30/2002 |
||||
DEVICE MODEL NUMBER |
CE17TK |
||||
DEVICE CATALOGUE NUMBER |
332221 |
||||
DEVICE LOT NUMBER |
60106519 |
||||
WAS DEVICE AVAILABLE FOR EVALUATION? |
NO |
||||
IS THE REPORTER A HEALTH PROFESSIONAL? |
YES |
||||
WAS THE REPORT SENT TO FDA? |
NO |
||||
DISTRIBUTOR FACILITY AWARE DATE |
06/10/2000 |
||||
EVENT LOCATION |
HOSPITAL |
||||
DATE MANUFACTURER RECEIVED |
07/26/2000 |
||||
WAS DEVICE EVALUATED BY MANUFACTURER? |
DEVICE NOT RETURNED TO MANUFACTURER |
||||
DATE DEVICE MANUFACTURED |
04/01/2000 |
||||
IS THE DEVICE SINGLE USE? |
YES |
||||
TYPE OF DEVICE USAGE |
UNKNOWN |
||||
PATIENT OUTCOME |
REQUIRED INTERVENTION |
ADVERSE EVENT OR PRODUCT PROBLEM DESCRIPTION |
REPORT DATE: 09/01/2000 MDR TEXT KEY: 1012982 Patient Sequence Number: 1 |
THE USER FACILITY REPORTED THE FOLLOWING: EPIDURAL CATHETER BROKE OFF IN PT DURING REMOVAL. THE PT WAS IN SITTING POSITION, WITHDRAWAL GOING AS USUAL, THEN CATHETER ELONGATED AND BROKE. |
|
ADDITIONAL MANUFACTURER NARRATIVE |
REPORT DATE: 09/01/2000 MDR TEXT KEY: 1012985 |
NO CONCLUSION CAN BE DRAWN SINCE THE DEVICE WAS NOT RETURNED FOR EVALUATION. NO FURTHER INFO IS AVAILABLE ON THE PT'S STATUS. IT SHOULD ALSO BE NOTED THAT THE LABELING ON THE INSTRUCTION SHEET STATES, "DO NOT WITHDRAW CATHETER THROUGH THE NEEDLE BECAUSE OF POSSIBLE DANGER OF SHEARING". |
32.
BRAND NAME |
PERIFIX |
||||
TYPE OF DEVICE |
CUSTOM EPIDURAL KIT |
||||
BASELINE BRAND NAME |
PERIFIX |
||||
BASELINE GENERIC NAME |
CUSTOM EPIDURAL TRAY |
||||
BASELINE CATALOGUE NUMBER |
555861 |
||||
BASELINE MODEL NUMBER |
CESK |
||||
BASELINE DEVICE FAMILY |
CONTINUOUS EPIDURAL TRAYS |
||||
BASELINE DEVICE 510(K) NUMBER |
K813186 |
||||
BASELINE SHELF LIFE INFORMATION |
YES |
||||
IS BASELINE PMA NUMBER PROVIDED?</< TH> |
NO |
||||
BASELINE PREAMENDMENT? |
NO |
||||
TRANSITIONAL? |
NO |
||||
510(K) EXEMPT? |
NO |
||||
SHELF LIFE(Months) |
12 |
||||
DATE FIRST MARKETED |
12/03/1981 |
||||
MANUFACTURER (Section F) |
|
||||
MANUFACTURER (Section D) |
|
||||
MANUFACTURER CONTACT |
|
||||
DEVICE EVENT KEY |
283878 |
||||
MDR REPORT KEY |
293277 |
||||
EVENT KEY |
275367 |
||||
REPORT NUMBER |
2523676-2000-00033 |
||||
DEVICE SEQUENCE NUMBER |
1 |
||||
PRODUCT CODE |
CAZ |
||||
REPORT SOURCE |
MANUFACTURER |
||||
SOURCE TYPE |
HEALTH PROFESSIONAL |
||||
REMEDIAL ACTION |
OTHER |
||||
EVENT TYPE |
INJURY |
||||
TYPE OF REPORT |
INITIAL |
||||
REPORT DATE |
08/28/2000 |
||||
1 DEVICE WAS INVOLVED IN THE EVENT |
|
||||
1 PATIENT WAS INVOLVED IN THE EVENT |
|
||||
DATE FDA RECEIVED |
08/28/2000 |
||||
IS THIS AN ADVERSE EVENT REPORT? |
YES |
||||
IS THIS A PRODUCT PROBLEM REPORT? |
NO |
||||
DEVICE OPERATOR |
HEALTH PROFESSIONAL |
||||
DEVICE EXPIRATION DATE |
06/30/2004 |
||||
DEVICE MODEL NUMBER |
CESK |
||||
DEVICE CATALOGUE NUMBER |
520016 |
||||
DEVICE LOT NUMBER |
60023646 |
||||
WAS DEVICE AVAILABLE FOR EVALUATION? |
NO |
||||
IS THE REPORTER A HEALTH PROFESSIONAL? |
YES |
||||
WAS THE REPORT SENT TO FDA? |
NO |
||||
DISTRIBUTOR FACILITY AWARE DATE |
08/03/2000 |
||||
DEVICE AGE |
1 YR |
||||
EVENT LOCATION |
HOSPITAL |
||||
DATE MANUFACTURER RECEIVED |
08/03/2000 |
||||
WAS DEVICE EVALUATED BY MANUFACTURER? |
DEVICE NOT RETURNED TO MANUFACTURER |
||||
DATE DEVICE MANUFACTURED |
06/01/1999 |
||||
IS THE DEVICE SINGLE USE? |
YES |
||||
TYPE OF DEVICE USAGE |
UNKNOWN |
||||
PATIENT OUTCOME |
REQUIRED INTERVENTION |
ADVERSE EVENT OR PRODUCT PROBLEM DESCRIPTION |
REPORT DATE: 08/28/2000 MDR TEXT KEY: 1006007 Patient Sequence Number: 1 |
THE USER FACILITY REPORTS THE FOLLOWING: ANESTHESIOLOGIST REPORTING THAT CATHETER SHEARED AT TIP. THE PHYSICIAN REPORTED THAT THE CATHETER WAS THREADED THROUGH NEEDLE, RESISTANCE WAS FELT, AND HE TRIED ADVANCING ONE MORE TIME STILL MEETING RESISTANCE. THE PHYSICIAN BEGAN TO PULL BACK ON CATHETER AND MET RESISTANCE AND TRIED TO PULL BACK AGAIN, STILL MEETING RESISTANCE. THE NEEDLE AND CATHETER WERE REMOVED TOGETHER AND NOTICED THEN THAT TIP WAS MISSING. |
|
ADDITIONAL MANUFACTURER NARRATIVE |
REPORT DATE: 08/28/2000 MDR TEXT KEY: 1006010 |
NO CONCLUSION CAN BE DRAWN, SINCE THE ACTUAL SAMPLE WAS NOT RETURNED. IT SHOULD ALSO BE NOTED THAT THE LABELING ON THE TRAY STATES, "DO NOT WITHDRAW CATHETER THROUGH THE NEEDLE BECAUSE OF POSSIBLE DANGER OF SHEARING". THIS REPORT WILL BE RE-OPENED IF ADD'L INFO BECOMES AVAILABLE.
|
33.
BRAND NAME |
PERIFIX |
||||
TYPE OF DEVICE |
PERIFIX CONTINUOUS EPIDURAL SET |
||||
BASELINE BRAND NAME |
PERIFIX |
||||
BASELINE GENERIC NAME |
PERIFIX CONTINUOUS EPIDURAL SET |
||||
BASELINE CATALOGUE NUMBER |
332205 |
||||
BASELINE MODEL NUMBER |
CE18C |
||||
MANUFACTURER (Section F) |
|
||||
MANUFACTURER (Section D) |
|
||||
MANUFACTURER CONTACT |
|
||||
DEVICE EVENT KEY |
281983 |
||||
MDR REPORT KEY |
291354 |
||||
EVENT KEY |
273501 |
||||
REPORT NUMBER |
2523676-2000-00030 |
||||
DEVICE SEQUENCE NUMBER |
1 |
||||
PRODUCT CODE |
CAZ |
||||
REPORT SOURCE |
MANUFACTURER |
||||
SOURCE TYPE |
USER FACILITY |
||||
REMEDIAL ACTION |
OTHER |
||||
EVENT TYPE |
INJURY |
||||
TYPE OF REPORT |
INITIAL |
||||
REPORT DATE |
08/14/2000 |
||||
1 DEVICE WAS INVOLVED IN THE EVENT |
|
||||
1 PATIENT WAS INVOLVED IN THE EVENT |
|
||||
DATE FDA RECEIVED |
08/16/2000 |
||||
IS THIS AN ADVERSE EVENT REPORT? |
YES |
||||
IS THIS A PRODUCT PROBLEM REPORT? |
NO |
||||
DEVICE OPERATOR |
HEALTH PROFESSIONAL |
||||
DEVICE EXPIRATION DATE |
11/01/2004 |
||||
DEVICE MODEL NUMBER |
CE18C |
||||
DEVICE CATALOGUE NUMBER |
332205 |
||||
DEVICE LOT NUMBER |
60072518 |
||||
WAS DEVICE AVAILABLE FOR EVALUATION? |
NO |
||||
IS THE REPORTER A HEALTH PROFESSIONAL? |
YES |
||||
WAS THE REPORT SENT TO FDA? |
NO |
||||
DEVICE AGE |
UNKNOWN |
||||
EVENT LOCATION |
HOSPITAL |
||||
DATE MANUFACTURER RECEIVED |
07/13/2000 |
||||
WAS DEVICE EVALUATED BY MANUFACTURER? |
DEVICE NOT RETURNED TO MANUFACTURER |
||||
DATE DEVICE MANUFACTURED |
06/01/2000 |
||||
IS THE DEVICE SINGLE USE? |
YES |
||||
TYPE OF DEVICE USAGE |
UNKNOWN |
||||
PATIENT OUTCOME |
OTHER |
ADVERSE EVENT OR PRODUCT PROBLEM DESCRIPTION |
REPORT DATE: 08/14/2000 MDR TEXT KEY: 999640 Patient Sequence Number: 1 |
THE USER FACILITY REPORTS NINE (9) OCCURRENCES OF STAPH AUREUS INFECTIONS AT THE EPIDURAL CATHETER INSERTION POINT FOLLOWING BACK SURGERIES AND EPIDURALS. THE INFECTION CONTROL GROUP IS INVESTIGATING ALL POTENTIAL SOURCES OF INFECTION, INCLUDING HOSPITAL STAFF, EQUIPMENT, ROOMS, AND PRODUCTS. DURING THIS INVESTIGATION, THE INFECTION CONTROL NURSE DID A GRAM STAIN OF THE CONTENTS OF THE WYETH-AYERST SODIUM CHLORIDE AMPOULE CONTAINED IN A B BRAUN KIT. THE GRAM STAIN TESTED POSITIVE FOR RARE PROTEUS SPECIES AND RARE GRAM POSITIVE COCCI. THIS WAS THE ONLY SAMPLE THE HOSPITAL HAD REMAINING FROM THIS LOT, AND HOSP WAS THEREFORE UNABLE TO PERFORM A RETEST. THE USER FACILITY INDICATED THAT THEY WOULD NOT HAVE NORMALLY CONTACTED THE MFR WITHOUT DOING A RE-TEST FIRST, BUT THEY DID NOT HAVE ANY MORE SAMPLES. THE HOSPITAL ALSO FOUND CONDENSATION IN THE CCU ROOM. THE FACILITY DID NOT PROVIDE ANY SPECIFIC INFO ON HOW THEIR TESTING WAS PERFORMED (I.E., HOW THE SAMPLES WERE HANDLED, STORED, CULTURED, ETC.). THE FACILITY REPORTED TWO DIFFERENT CATALOG NUMBERS (332205 AND 555611), BECAUSE THE FACILITY USES BOTH, BUT THESE EVENTS WERE NOT ATTRIBUTED TO EITHER CATALOG NUMBER SPECIFICALLY. B. BRAUN TESTED SAMPLES FROM THE REPORTED LOT OF SODIUM CHLORIDE (WYETH LOT #119095) WITH NEGATIVE RESULTS. THESE EVENTS ARE ISOLATED TO THIS FACILITY. THERE HAVE BEEN NO OTHER OCCURRENCES OF THIS NATURE REPORTED FROM ANY OTHER FACILITIES USING THESE PRODUCTS. THERE IS NO FURTHER INFO AVAILABLE ON THE PT'S STATUS. |
|
ADDITIONAL MANUFACTURER NARRATIVE |
REPORT DATE: 08/14/2000 MDR TEXT KEY: 999641 |
THERE WERE NO KITS OF THE REPORTED LOT AVAILABLE FOR TESTING, BUT KITS CONTAINING THE SAME LOT OF SODIUM CHLORIDE (WYETH LOT#119095) WERE RETRIEVED FROM INVENTORY AND TESTED. ONE CASE WAS SENT TO WYETH-AYERST FOR TESTING, AND ONE WAS TESTED AT B. BRAUN'S MICROBIOLOGY LAB ALONG WITH TWO ADDITIONAL LOTS FOR CONTROL TESTING (7/20/00). BRAUN'S TESTING RESULTS CONCLUDED THAT NO BACTERIAL OR FUNGAL CONTAMINATION WAS PRESENT IN ANY OF THESE SAMPLES. THERE IS NO EVIDENCE THAT INDICATES THAT THESE OCCURRENCES WERE THE RESULT OF ANY STERILITY OR QUALITY DEFICIENCY WITH THIS PRODUCT. |
|
34.
BRAND NAME |
PERIFIX |
||||
TYPE OF DEVICE |
PERIFIX CONTINUOUS EPIDURAL SET |
||||
BASELINE BRAND NAME |
PERIFIX |
||||
BASELINE GENERIC NAME |
PERIFIX CONTINUOUS EPIDURAL SET |
||||
BASELINE CATALOGUE NUMBER |
332205 |
||||
BASELINE MODEL NUMBER |
CE18C |
||||
MANUFACTURER (Section F) |
|
||||
MANUFACTURER (Section D) |
|
||||
MANUFACTURER CONTACT |
|
||||
DEVICE EVENT KEY |
281968 |
||||
MDR REPORT KEY |
291339 |
||||
EVENT KEY |
273489 |
||||
REPORT NUMBER |
2523676-2000-00031 |
||||
DEVICE SEQUENCE NUMBER |
1 |
||||
PRODUCT CODE |
CAZ |
||||
REPORT SOURCE |
MANUFACTURER |
||||
SOURCE TYPE |
USER FACILITY |
||||
REMEDIAL ACTION |
OTHER |
||||
EVENT TYPE |
INJURY |
||||
TYPE OF REPORT |
INITIAL |
||||
REPORT DATE |
08/14/2000 |
||||
1 DEVICE WAS INVOLVED IN THE EVENT |
|
||||
1 PATIENT WAS INVOLVED IN THE EVENT |
|
||||
DATE FDA RECEIVED |
08/16/2000 |
||||
IS THIS AN ADVERSE EVENT REPORT? |
YES |
||||
IS THIS A PRODUCT PROBLEM REPORT? |
NO |
||||
DEVICE OPERATOR |
HEALTH PROFESSIONAL |
||||
DEVICE EXPIRATION DATE |
11/01/2004 |
||||
DEVICE MODEL NUMBER |
CE18C |
||||
DEVICE CATALOGUE NUMBER |
332205 |
||||
DEVICE LOT NUMBER |
60072518 |
||||
WAS DEVICE AVAILABLE FOR EVALUATION? |
NO |
||||
IS THE REPORTER A HEALTH PROFESSIONAL? |
YES |
||||
WAS THE REPORT SENT TO FDA? |
NO |
||||
DEVICE AGE |
UNKNOWN |
||||
EVENT LOCATION |
HOSPITAL |
||||
DATE MANUFACTURER RECEIVED |
07/13/2000 |
||||
WAS DEVICE EVALUATED BY MANUFACTURER? |
DEVICE NOT RETURNED TO MANUFACTURER |
||||
DATE DEVICE MANUFACTURED |
06/01/2000 |
||||
IS THE DEVICE SINGLE USE? |
YES |
||||
TYPE OF DEVICE USAGE |
UNKNOWN |
||||
PATIENT OUTCOME |
OTHER |
ADVERSE EVENT OR PRODUCT PROBLEM DESCRIPTION |
REPORT DATE: 08/14/2000 MDR TEXT KEY: 999600 Patient Sequence Number: 1 |
THE USER FACILITY REPORTS NINE (9) OCCURRENCES OF STAPH AUREUS INFECTIONS AT THE EPIDURAL CATHETER INSERTION POINT FOLLOWING BACK SURGERIES AND EPIDURALS. THE INFECTION CONTROL GROUP IS INVESTIGATING ALL POTENTIAL SOURCES OF INFECTION, INCLUDING HOSPITAL STAFF, EQUIPMENT, ROOMS, AND PRODUCTS. DURING THIS INVESTIGATION, THE INFECTION CONTROL NURSE DID A GRAM STAIN OF THE CONTENTS OF THE WYETH-AYERST SODIUM CHLORIDE AMPOULE CONTAINED IN A B BRAUN KIT. THE GRAM STAIN TESTED POSITIVE FOR RARE PROTEUS SPECIES AND RARE GRAM POSITIVE COCCI. THIS WAS THE ONLY SAMPLE THE HOSPITAL HAD REMAINING FROM THIS LOT, AND HOSP WAS THEREFORE UNABLE TO PERFORM A RETEST. THE USER FACILITY INDICATED THAT THEY WOULD NOT HAVE NORMALLY CONTACTED THE MFR WITHOUT DOING A RE-TEST FIRST, BUT THEY DID NOT HAVE ANY MORE SAMPLES. THE HOSPITAL ALSO FOUND CONDENSATION IN THE CCU ROOM. THE FACILITY DID NOT PROVIDE ANY SPECIFIC INFO ON HOW THEIR TESTING WAS PERFORMED (I.E., HOW THE SAMPLES WERE HANDLED, STORED, CULTURED, ETC.). THE FACILITY REPORTED TWO DIFFERENT CATALOG NUMBERS (332205 AND 555611), BECAUSE THE FACILITY USES BOTH, BUT THESE EVENTS WERE NOT ATTRIBUTED TO EITHER CATALOG NUMBER SPECIFICALLY. B. BRAUN TESTED SAMPLES FROM THE REPORTED LOT OF SODIUM CHLORIDE (WYETH LOT #119095) WITH NEGATIVE RESULTS. THESE EVENTS ARE ISOLATED TO THIS FACILITY. THERE HAVE BEEN NO OTHER OCCURRENCES OF THIS NATURE REPORTED FROM ANY OTHER FACILITIES USING THESE PRODUCTS. THERE IS NO FURTHER INFO AVAILABLE ON THE PT'S STATUS. |
|
ADDITIONAL MANUFACTURER NARRATIVE |
REPORT DATE: 08/14/2000 MDR TEXT KEY: 999601 |
THERE WERE NO KITS OF THE REPORTED LOT AVAILABLE FOR TESTING, BUT KITS CONTAINING THE SAME LOT OF SODIUM CHLORIDE (WYETH LOT#119095) WERE RETRIEVED FROM INVENTORY AND TESTED. ONE CASE WAS SENT TO WYETH-AYERST FOR TESTING, AND ONE WAS TESTED AT B. BRAUN'S MICROBIOLOGY LAB ALONG WITH TWO ADDITIONAL LOTS FOR CONTROL TESTING (7/20/00). BRAUN'S TESTING RESULTS CONCLUDED THAT NO BACTERIAL OR FUNGAL CONTAMINATION WAS PRESENT IN ANY OF THESE SAMPLES. THERE IS NO EVIDENCE THAT INDICATES THAT THESE OCCURRENCES WERE THE RESULT OF ANY STERILITY OR QUALITY DEFICIENCY WITH THIS PRODUCT. |
35.
BRAND NAME |
PERIFIX |
||||
TYPE OF DEVICE |
PERIFIX CONTINUOUS EPIDURAL SET |
||||
BASELINE BRAND NAME |
PERIFIX |
||||
BASELINE GENERIC NAME |
PERIFIX CONTINUOUS EPIDURAL SET |
||||
BASELINE CATALOGUE NUMBER |
332205 |
||||
BASELINE MODEL NUMBER |
CE18C |
||||
MANUFACTURER (Section F) |
|
||||
MANUFACTURER (Section D) |
|
||||
MANUFACTURER CONTACT |
|
||||
DEVICE EVENT KEY |
281981 |
||||
MDR REPORT KEY |
291352 |
||||
EVENT KEY |
273499 |
||||
REPORT NUMBER |
2523676-2000-00028 |
||||
DEVICE SEQUENCE NUMBER |
1 |
||||
PRODUCT CODE |
CAZ |
||||
REPORT SOURCE |
MANUFACTURER |
||||
SOURCE TYPE |
USER FACILITY |
||||
REMEDIAL ACTION |
OTHER |
||||
EVENT TYPE |
INJURY |
||||
TYPE OF REPORT |
INITIAL |
||||
REPORT DATE |
08/14/2000 |
||||
1 DEVICE WAS INVOLVED IN THE EVENT |
|
||||
1 PATIENT WAS INVOLVED IN THE EVENT |
|
||||
DATE FDA RECEIVED |
08/16/2000 |
||||
IS THIS AN ADVERSE EVENT REPORT? |
YES |
||||
IS THIS A PRODUCT PROBLEM REPORT? |
NO |
||||
DEVICE OPERATOR |
HEALTH PROFESSIONAL |
||||
DEVICE EXPIRATION DATE |
11/01/2004 |
||||
DEVICE MODEL NUMBER |
CE18C |
||||
DEVICE CATALOGUE NUMBER |
332205 |
||||
DEVICE LOT NUMBER |
60072518 |
||||
WAS DEVICE AVAILABLE FOR EVALUATION? |
NO |
||||
IS THE REPORTER A HEALTH PROFESSIONAL? |
YES |
||||
WAS THE REPORT SENT TO FDA? |
NO |
||||
DEVICE AGE |
UNKNOWN |
||||
EVENT LOCATION |
HOSPITAL |
||||
DATE MANUFACTURER RECEIVED |
07/13/2000 |
||||
WAS DEVICE EVALUATED BY MANUFACTURER? |
DEVICE NOT RETURNED TO MANUFACTURER |
||||
DATE DEVICE MANUFACTURED |
06/01/2000 |
||||
IS THE DEVICE SINGLE USE? |
YES |
||||
TYPE OF DEVICE USAGE |
UNKNOWN |
||||
PATIENT OUTCOME |
OTHER |
ADVERSE EVENT OR PRODUCT PROBLEM DESCRIPTION |
REPORT DATE: 08/14/2000 MDR TEXT KEY: 999636 Patient Sequence Number: 1 |
THE USER FACILITY REPORTS NINE (9) OCCURRENCES OF STAPH AUREUS INFECTIONS AT THE EPIDURAL CATHETER INSERTION POINT FOLLOWING BACK SURGERIES AND EPIDURALS. THE INFECTION CONTROL GROUP IS INVESTIGATING ALL POTENTIAL SOURCES OF INFECTION, INCLUDING HOSPITAL STAFF, EQUIPMENT, ROOMS, AND PRODUCTS. DURING THIS INVESTIGATION, THE INFECTION CONTROL NURSE DID A GRAM STAIN OF THE CONTENTS OF THE WYETH-AYERST SODIUM CHLORIDE AMPOULE CONTAINED IN A B BRAUN KIT. THE GRAM STAIN TESTED POSITIVE FOR RARE PROTEUS SPECIES AND RARE GRAM POSITIVE COCCI. THIS WAS THE ONLY SAMPLE THE HOSPITAL HAD REMAINING FROM THIS LOT, AND HOSP WAS THEREFORE UNABLE TO PERFORM A RETEST. THE USER FACILITY INDICATED THAT THEY WOULD NOT HAVE NORMALLY CONTACTED THE MFR WITHOUT DOING A RE-TEST FIRST, BUT THEY DID NOT HAVE ANY MORE SAMPLES. THE HOSPITAL ALSO FOUND CONDENSATION IN THE CCU ROOM. THE FACILITY DID NOT PROVIDE ANY SPECIFIC INFO ON HOW THEIR TESTING WAS PERFORMED (I.E., HOW THE SAMPLES WERE HANDLED, STORED, CULTURED, ETC.). THE FACILITY REPORTED TWO DIFFERENT CATALOG NUMBERS (332205 AND 555611), BECAUSE THE FACILITY USES BOTH, BUT THESE EVENTS WERE NOT ATTRIBUTED TO EITHER CATALOG NUMBER SPECIFICALLY. B. BRAUN TESTED SAMPLES FROM THE REPORTED LOT OF SODIUM CHLORIDE (WYETH LOT #119095) WITH NEGATIVE RESULTS. THESE EVENTS ARE ISOLATED TO THIS FACILITY. THERE HAVE BEEN NO OTHER OCCURRENCES OF THIS NATURE REPORTED FROM ANY OTHER FACILITIES USING THESE PRODUCTS. THERE IS NO FURTHER INFO AVAILABLE ON THE PT'S STATUS. |
|
ADDITIONAL MANUFACTURER NARRATIVE |
REPORT DATE: 08/14/2000 MDR TEXT KEY: 999637 |
THERE WERE NO KITS OF THE REPORTED LOT AVAILABLE FOR TESTING, BUT KITS CONTAINING THE SAME LOT OF SODIUM CHLORIDE (WYETH LOT#119095) WERE RETRIEVED FROM INVENTORY AND TESTED. ONE CASE WAS SENT TO WYETH-AYERST FOR TESTING, AND ONE WAS TESTED AT B. BRAUN'S MICROBIOLOGY LAB ALONG WITH TWO ADDITIONAL LOTS FOR CONTROL TESTING (7/20/00). BRAUN'S TESTING RESULTS CONCLUDED THAT NO BACTERIAL OR FUNGAL CONTAMINATION WAS PRESENT IN ANY OF THESE SAMPLES. THERE IS NO EVIDENCE THAT INDICATES THAT THESE OCCURRENCES WERE THE RESULT OF ANY STERILITY OR QUALITY DEFICIENCY WITH THIS PRODUCT. |
36.
BRAND NAME |
PERIFIX |
||||
TYPE OF DEVICE |
PERIFIX CONTINUOUS EPIDURAL SET |
||||
BASELINE BRAND NAME |
PERIFIX |
||||
BASELINE GENERIC NAME |
PERIFIX CONTINUOUS EPIDURAL SET |
||||
BASELINE CATALOGUE NUMBER |
332205 |
||||
BASELINE MODEL NUMBER |
CE18C |
||||
MANUFACTURER (Section F) |
|
||||
MANUFACTURER (Section D) |
|
||||
MANUFACTURER CONTACT |
|
||||
DEVICE EVENT KEY |
281982 |
||||
MDR REPORT KEY |
291353 |
||||
EVENT KEY |
273500 |
||||
REPORT NUMBER |
2523676-2000-00029 |
||||
DEVICE SEQUENCE NUMBER |
1 |
||||
PRODUCT CODE |
CAZ |
||||
REPORT SOURCE |
MANUFACTURER |
||||
SOURCE TYPE |
USER FACILITY |
||||
REMEDIAL ACTION |
OTHER |
||||
EVENT TYPE |
INJURY |
||||
TYPE OF REPORT |
INITIAL |
||||
REPORT DATE |
08/14/2000 |
||||
1 DEVICE WAS INVOLVED IN THE EVENT |
|
||||
1 PATIENT WAS INVOLVED IN THE EVENT |
|
||||
DATE FDA RECEIVED |
08/16/2000 |
||||
IS THIS AN ADVERSE EVENT REPORT? |
YES |
||||
IS THIS A PRODUCT PROBLEM REPORT? |
NO |
||||
DEVICE OPERATOR |
HEALTH PROFESSIONAL |
||||
DEVICE EXPIRATION DATE |
11/01/2004 |
||||
DEVICE MODEL NUMBER |
CE18C |
||||
DEVICE CATALOGUE NUMBER |
332205 |
||||
DEVICE LOT NUMBER |
60072518 |
||||
WAS DEVICE AVAILABLE FOR EVALUATION? |
NO |
||||
IS THE REPORTER A HEALTH PROFESSIONAL? |
YES |
||||
WAS THE REPORT SENT TO FDA? |
NO |
||||
DEVICE AGE |
UNKNOWN |
||||
EVENT LOCATION |
HOSPITAL |
||||
DATE MANUFACTURER RECEIVED |
07/13/2000 |
||||
WAS DEVICE EVALUATED BY MANUFACTURER? |
DEVICE NOT RETURNED TO MANUFACTURER |
||||
DATE DEVICE MANUFACTURED |
06/01/2000 |
||||
IS THE DEVICE SINGLE USE? |
YES |
||||
TYPE OF DEVICE USAGE |
UNKNOWN |
||||
PATIENT OUTCOME |
OTHER |
ADDITIONAL MANUFACTURER NARRATIVE |
REPORT DATE: 08/14/2000 MDR TEXT KEY: 999639 |
THERE WERE NO KITS OF THE REPORTED LOT AVAILABLE FOR TESTING, BUT KITS CONTAINING THE SAME LOT OF SODIUM CHLORIDE (WYETH LOT#119095) WERE RETRIEVED FROM INVENTORY AND TESTED. ONE CASE WAS SENT TO WYETH-AYERST FOR TESTING, AND ONE WAS TESTED AT B. BRAUN'S MICROBIOLOGY LAB ALONG WITH TWO ADDITIONAL LOTS FOR CONTROL TESTING (7/20/00). BRAUN'S TESTING RESULTS CONCLUDED THAT NO BACTERIAL OR FUNGAL CONTAMINATION WAS PRESENT IN ANY OF THESE SAMPLES. THERE IS NO EVIDENCE THAT INDICATES THAT THESE OCCURRENCES WERE THE RESULT OF ANY STERILITY OR QUALITY DEFICIENCY WITH THIS PRODUCT. |
|
ADVERSE EVENT OR PRODUCT PROBLEM DESCRIPTION |
REPORT DATE: 08/14/2000 MDR TEXT KEY: 999638 Patient Sequence Number: 1 |
THE USER FACILITY REPORTS NINE (9) OCCURRENCES OF STAPH AUREUS INFECTIONS AT THE EPIDURAL CATHETER INSERTION POINT FOLLOWING BACK SURGERIES AND EPIDURALS. THE INFECTION CONTROL GROUP IS INVESTIGATING ALL POTENTIAL SOURCES OF INFECTION, INCLUDING HOSPITAL STAFF, EQUIPMENT, ROOMS, AND PRODUCTS. DURING THIS INVESTIGATION, THE INFECTION CONTROL NURSE DID A GRAM STAIN OF THE CONTENTS OF THE WYETH-AYERST SODIUM CHLORIDE AMPOULE CONTAINED IN A B BRAUN KIT. THE GRAM STAIN TESTED POSITIVE FOR RARE PROTEUS SPECIES AND RARE GRAM POSITIVE COCCI. THIS WAS THE ONLY SAMPLE THE HOSPITAL HAD REMAINING FROM THIS LOT, AND HOSP WAS THEREFORE UNABLE TO PERFORM A RETEST. THE USER FACILITY INDICATED THAT THEY WOULD NOT HAVE NORMALLY CONTACTED THE MFR WITHOUT DOING A RE-TEST FIRST, BUT THEY DID NOT HAVE ANY MORE SAMPLES. THE HOSPITAL ALSO FOUND CONDENSATION IN THE CCU ROOM. THE FACILITY DID NOT PROVIDE ANY SPECIFIC INFO ON HOW THEIR TESTING WAS PERFORMED (I.E., HOW THE SAMPLES WERE HANDLED, STORED, CULTURED, ETC.). THE FACILITY REPORTED TWO DIFFERENT CATALOG NUMBERS (332205 AND 555611), BECAUSE THE FACILITY USES BOTH, BUT THESE EVENTS WERE NOT ATTRIBUTED TO EITHER CATALOG NUMBER SPECIFICALLY. B. BRAUN TESTED SAMPLES FROM THE REPORTED LOT OF SODIUM CHLORIDE (WYETH LOT #119095) WITH NEGATIVE RESULTS. THESE EVENTS ARE ISOLATED TO THIS FACILITY. THERE HAVE BEEN NO OTHER OCCURRENCES OF THIS NATURE REPORTED FROM ANY OTHER FACILITIES USING THESE PRODUCTS. THERE IS NO FURTHER INFO AVAILABLE ON THE PT'S STATUS. |
37.
BRAND NAME |
PERIFIX |
||||
TYPE OF DEVICE |
PERIFIX CONTINUOUS EPIDURAL SET |
||||
BASELINE BRAND NAME |
PERIFIX |
||||
BASELINE GENERIC NAME |
PERIFIX CONTINUOUS EPIDURAL SET |
||||
BASELINE CATALOGUE NUMBER |
332205 |
||||
BASELINE MODEL NUMBER |
CE18C |
||||
MANUFACTURER (Section F) |
|
||||
MANUFACTURER (Section D) |
|
||||
MANUFACTURER CONTACT |
|
||||
DEVICE EVENT KEY |
281987 |
||||
MDR REPORT KEY |
291358 |
||||
EVENT KEY |
273505 |
||||
REPORT NUMBER |
2523676-2000-00023 |
||||
DEVICE SEQUENCE NUMBER |
1 |
||||
PRODUCT CODE |
CAZ |
||||
REPORT SOURCE |
MANUFACTURER |
||||
SOURCE TYPE |
USER FACILITY |
||||
REMEDIAL ACTION |
OTHER |
||||
EVENT TYPE |
INJURY |
||||
TYPE OF REPORT |
INITIAL |
||||
REPORT DATE |
08/14/2000 |
||||
1 DEVICE WAS INVOLVED IN THE EVENT |
|
||||
1 PATIENT WAS INVOLVED IN THE EVENT |
|
||||
DATE FDA RECEIVED |
08/16/2000 |
||||
IS THIS AN ADVERSE EVENT REPORT? |
YES |
||||
IS THIS A PRODUCT PROBLEM REPORT? |
NO |
||||
DEVICE OPERATOR |
HEALTH PROFESSIONAL |
||||
DEVICE EXPIRATION DATE |
11/01/2004 |
||||
DEVICE MODEL NUMBER |
CE18C |
||||
DEVICE CATALOGUE NUMBER |
332205 |
||||
DEVICE LOT NUMBER |
60072518 |
||||
WAS DEVICE AVAILABLE FOR EVALUATION? |
NO |
||||
IS THE REPORTER A HEALTH PROFESSIONAL? |
YES |
||||
WAS THE REPORT SENT TO FDA? |
NO |
||||
DEVICE AGE |
UNKNOWN |
||||
EVENT LOCATION |
HOSPITAL |
||||
DATE MANUFACTURER RECEIVED |
07/13/2000 |
||||
WAS DEVICE EVALUATED BY MANUFACTURER? |
DEVICE NOT RETURNED TO MANUFACTURER |
||||
DATE DEVICE MANUFACTURED |
06/01/2000 |
||||
IS THE DEVICE SINGLE USE? |
YES |
||||
TYPE OF DEVICE USAGE |
UNKNOWN |
||||
PATIENT OUTCOME |
OTHER |
ADVERSE EVENT OR PRODUCT PROBLEM DESCRIPTION |
REPORT DATE: 08/14/2000 MDR TEXT KEY: 999652 Patient Sequence Number: 1 |
THE USER FACILITY REPORTS NINE (9) OCCURRENCES OF STAPH AUREUS INFECTIONS AT THE EPIDURAL CATHETER INSERTION POINT FOLLOWING BACK SURGERIES AND EPIDURALS. THE INFECTION CONTROL GROUP IS INVESTIGATING ALL POTENTIAL SOURCES OF INFECTION, INCLUDING HOSPITAL STAFF, EQUIPMENT, ROOMS, AND PRODUCTS. DURING THIS INVESTIGATION, THE INFECTION CONTROL NURSE DID A GRAM STAIN OF THE CONTENTS OF THE WYETH-AYERST SODIUM CHLORIDE AMPOULE CONTAINED IN A B BRAUN KIT. THE GRAM STAIN TESTED POSITIVE FOR RARE PROTEUS SPECIES AND RARE GRAM POSITIVE COCCI. THIS WAS THE ONLY SAMPLE THE HOSPITAL HAD REMAINING FROM THIS LOT, AND HOSP WAS THEREFORE UNABLE TO PERFORM A RETEST. THE USER FACILITY INDICATED THAT THEY WOULD NOT HAVE NORMALLY CONTACTED THE MFR WITHOUT DOING A RE-TEST FIRST, BUT THEY DID NOT HAVE ANY MORE SAMPLES. THE HOSPITAL ALSO FOUND CONDENSATION IN THE CCU ROOM. THE FACILITY DID NOT PROVIDE ANY SPECIFIC INFO ON HOW THEIR TESTING WAS PERFORMED (I.E., HOW THE SAMPLES WERE HANDLED, STORED, CULTURED, ETC.). THE FACILITY REPORTED TWO DIFFERENT CATALOG NUMBERS (332205 AND 555611), BECAUSE THE FACILITY USES BOTH, BUT THESE EVENTS WERE NOT ATTRIBUTED TO EITHER CATALOG NUMBER SPECIFICALLY. B. BRAUN TESTED SAMPLES FROM THE REPORTED LOT OF SODIUM CHLORIDE (WYETH LOT #119095) WITH NEGATIVE RESULTS. THESE EVENTS ARE ISOLATED TO THIS FACILITY. THERE HAVE BEEN NO OTHER OCCURRENCES OF THIS NATURE REPORTED FROM ANY OTHER FACILITIES USING THESE PRODUCTS. THERE IS NO FURTHER INFO AVAILABLE ON THE PT'S STATUS. |
|
ADDITIONAL MANUFACTURER NARRATIVE |
REPORT DATE: 08/14/2000 MDR TEXT KEY: 999653 |
THERE WERE NO KITS OF THE REPORTED LOT AVAILABLE FOR TESTING, BUT KITS CONTAINING THE SAME LOT OF SODIUM CHLORIDE (WYETH LOT#119095) WERE RETRIEVED FROM INVENTORY AND TESTED. ONE CASE WAS SENT TO WYETH-AYERST FOR TESTING, AND ONE WAS TESTED AT B. BRAUN'S MICROBIOLOGY LAB ALONG WITH TWO ADDITIONAL LOTS FOR CONTROL TESTING (7/20/00). BRAUN'S TESTING RESULTS CONCLUDED THAT NO BACTERIAL OR FUNGAL CONTAMINATION WAS PRESENT IN ANY OF THESE SAMPLES. THERE IS NO EVIDENCE THAT INDICATES THAT THESE OCCURRENCES WERE THE RESULT OF ANY STERILITY OR QUALITY DEFICIENCY WITH THIS PRODUCT. |
38.
BRAND NAME |
PERIFIX |
||||
TYPE OF DEVICE |
PERIFIX CONTINUOUS EPIDURAL SET |
||||
BASELINE BRAND NAME |
PERIFIX |
||||
BASELINE GENERIC NAME |
PERIFIX CONTINUOUS EPIDURAL SET |
||||
BASELINE CATALOGUE NUMBER |
332205 |
||||
BASELINE MODEL NUMBER |
CE18C |
||||
MANUFACTURER (Section F) |
|
||||
MANUFACTURER (Section D) |
|
||||
MANUFACTURER CONTACT |
|
||||
DEVICE EVENT KEY |
281973 |
||||
MDR REPORT KEY |
291344 |
||||
EVENT KEY |
273493 |
||||
REPORT NUMBER |
2523676-2000-00024 |
||||
DEVICE SEQUENCE NUMBER |
1 |
||||
PRODUCT CODE |
CAZ |
||||
REPORT SOURCE |
MANUFACTURER |
||||
SOURCE TYPE |
USER FACILITY |
||||
REMEDIAL ACTION |
OTHER |
||||
EVENT TYPE |
INJURY |
||||
TYPE OF REPORT |
INITIAL |
||||
REPORT DATE |
08/14/2000 |
||||
1 DEVICE WAS INVOLVED IN THE EVENT |
|
||||
1 PATIENT WAS INVOLVED IN THE EVENT |
|
||||
DATE FDA RECEIVED |
08/16/2000 |
||||
IS THIS AN ADVERSE EVENT REPORT? |
YES |
||||
IS THIS A PRODUCT PROBLEM REPORT? |
NO |
||||
DEVICE OPERATOR |
HEALTH PROFESSIONAL |
||||
DEVICE EXPIRATION DATE |
11/01/2004 |
||||
DEVICE MODEL NUMBER |
CE18C |
||||
DEVICE CATALOGUE NUMBER |
332205 |
||||
DEVICE LOT NUMBER |
60072518 |
||||
WAS DEVICE AVAILABLE FOR EVALUATION? |
NO |
||||
IS THE REPORTER A HEALTH PROFESSIONAL? |
YES |
||||
WAS THE REPORT SENT TO FDA? |
NO |
||||
DEVICE AGE |
UNKNOWN |
||||
EVENT LOCATION |
HOSPITAL |
||||
DATE MANUFACTURER RECEIVED |
07/13/2000 |
||||
WAS DEVICE EVALUATED BY MANUFACTURER? |
DEVICE NOT RETURNED TO MANUFACTURER |
||||
DATE DEVICE MANUFACTURED |
06/01/2000 |
||||
IS THE DEVICE SINGLE USE? |
YES |
||||
TYPE OF DEVICE USAGE |
UNKNOWN |
||||
PATIENT OUTCOME |
OTHER |
ADVERSE EVENT OR PRODUCT PROBLEM DESCRIPTION |
REPORT DATE: 08/14/2000 MDR TEXT KEY: 999612 Patient Sequence Number: 1 |
THE USER FACILITY REPORTS NINE (9) OCCURRENCES OF STAPH AUREUS INFECTIONS AT THE EPIDURAL CATHETER INSERTION POINT FOLLOWING BACK SURGERIES AND EPIDURALS. THE INFECTION CONTROL GROUP IS INVESTIGATING ALL POTENTIAL SOURCES OF INFECTION, INCLUDING HOSPITAL STAFF, EQUIPMENT, ROOMS, AND PRODUCTS. DURING THIS INVESTIGATION, THE INFECTION CONTROL NURSE DID A GRAM STAIN OF THE CONTENTS OF THE WYETH-AYERST SODIUM CHLORIDE AMPOULE CONTAINED IN KIT B BRAUN KIT. THE GRAM STAIN TESTED POSITIVE FOR RARE PROTEUS SPECIES AND RARE GRAM POSITIVE COCCI. THIS WAS THE ONLY SAMPLE THE HOSPITAL HAD REMAINING FROM THIS LOT, AND HOSP WAS THEREFORE UNABLE TO PERFORM A RETEST. THE USER FACILITY INDICATED THAT THEY WOULD NOT HAVE NORMALLY CONTACTED THE MFR WITHOUT DOING A RE-TEST FIRST, BUT THEY DID NOT HAVE ANY MORE SAMPLES. THE HOSPITAL ALSO FOUND CONDENSATION IN THE CCU ROOM. THE FACILITY DID NOT PROVIDE ANY SPECIFIC INFO ON HOW THEIR TESTING WAS PERFORMED (I.E., HOW THE SAMPLES WERE HANDLED, STORED, CULTURED, ETC.). THE FACILITY REPORTED TWO DIFFERENT CATALOG NUMBERS (332205 AND 555611), BECAUSE THE FACILITY USES BOTH, BUT THESE EVENTS WERE NOT ATTRIBUTED TO EITHER CATALOG NUMBER SPECIFICALLY. B. BRAUN TESTED SAMPLES FROM THE REPORTED LOT OF SODIUM CHLORIDE (WYETH LOT #119095) WITH NEGATIVE RESULTS. THESE EVENTS ARE ISOLATED TO THIS FACILITY. THERE HAVE BEEN NO OTHER OCCURRENCES OF THIS NATURE REPORTED FROM ANY OTHER FACILITIES USING THESE PRODUCTS. THERE IS NO FURTHER INFO AVAILABLE ON THE PT'S STATUS. |
|
ADDITIONAL MANUFACTURER NARRATIVE |
REPORT DATE: 08/16/2000 MDR TEXT KEY: 999613 |
THERE WERE NO KITS OF THE REPORTED LOT AVAILABLE FOR TESTING, BUT KITS CONTAINING THE SAME LOT OF SODIUM CHLORIDE (WYETH LOT #119095) WERE RETRIEVED FROM INVENTORY AND TESTED. ONE CASE WAS SENT TO WYETH-AYERST FOR TESTING, AND ONE WAS TESTED AT B. BRAUN'S MICROBIOLOGY LAB ALONG WITH TWO ADDITIONAL LOTS FOR CONTROL TESTING (7/20/00). BRAUN'S TESTING RESULTS CONCLUDED THAT NO BACTERIAL OR FUNGAL CONTAMINATION WAS PRESENT IN ANY OF THESE SAMPLES. THERE IS NO EVIDENCE THAT INDICATES THAT THESE OCCURRENCES WERE THE RESULT OF ANY STERILITY OR QUALITY DEFICIENCY WITH THIS PRODUCT. |
39.
BRAND NAME |
PERIFIX |
||||
TYPE OF DEVICE |
PERIFIX CONTINUOUS EPIDURAL SET |
||||
BASELINE BRAND NAME |
PERIFIX |
||||
BASELINE GENERIC NAME |
PERIFIX CONTINUOUS EPIDURAL SET |
||||
BASELINE CATALOGUE NUMBER |
332205 |
||||
BASELINE MODEL NUMBER |
CE18C |
||||
MANUFACTURER (Section F) |
|
||||
MANUFACTURER (Section D) |
|
||||
MANUFACTURER CONTACT |
|
||||
DEVICE EVENT KEY |
281975 |
||||
MDR REPORT KEY |
291346 |
||||
EVENT KEY |
273494 |
||||
REPORT NUMBER |
2523676-2000-00025 |
||||
DEVICE SEQUENCE NUMBER |
1 |
||||
PRODUCT CODE |
CAZ |
||||
REPORT SOURCE |
MANUFACTURER |
||||
SOURCE TYPE |
USER FACILITY |
||||
REMEDIAL ACTION |
OTHER |
||||
EVENT TYPE |
INJURY |
||||
TYPE OF REPORT |
INITIAL |
||||
REPORT DATE |
08/14/2000 |
||||
1 DEVICE WAS INVOLVED IN THE EVENT |
|
||||
1 PATIENT WAS INVOLVED IN THE EVENT |
|
||||
DATE FDA RECEIVED |
08/16/2000 |
||||
IS THIS AN ADVERSE EVENT REPORT? |
YES |
||||
IS THIS A PRODUCT PROBLEM REPORT? |
NO |
||||
DEVICE OPERATOR |
HEALTH PROFESSIONAL |
||||
DEVICE EXPIRATION DATE |
11/01/2004 |
||||
DEVICE MODEL NUMBER |
CE18C |
||||
DEVICE CATALOGUE NUMBER |
332205 |
||||
DEVICE LOT NUMBER |
60072518 |
||||
WAS DEVICE AVAILABLE FOR EVALUATION? |
NO |
||||
IS THE REPORTER A HEALTH PROFESSIONAL? |
YES |
||||
WAS THE REPORT SENT TO FDA? |
NO |
||||
DEVICE AGE |
UNKNOWN |
||||
EVENT LOCATION |
HOSPITAL |
||||
DATE MANUFACTURER RECEIVED |
07/13/2000 |
||||
WAS DEVICE EVALUATED BY MANUFACTURER? |
DEVICE NOT RETURNED TO MANUFACTURER |
||||
DATE DEVICE MANUFACTURED |
06/01/2000 |
||||
IS THE DEVICE SINGLE USE? |
YES |
||||
TYPE OF DEVICE USAGE |
UNKNOWN |
||||
PATIENT OUTCOME |
OTHER |
ADDITIONAL MANUFACTURER NARRATIVE |
REPORT DATE: 08/16/2000 MDR TEXT KEY: 999619 |
THERE WERE NO KITS OF THE REPORTED LOT AVAILABLE FOR TESTING, BUT KITS CONTAINING THE SAME LOT OF SODIUM CHLORIDE (WYETH LOT #119095) WERE RETRIEVED FROM INVENTORY AND TESTED. ONE CASE WAS SENT TO WYETH-AYERST FOR TESTING, AND ONE WAS TESTED AT B. BRAUN'S MICROBIOLOGY LAB ALONG WITH TWO ADDITIONAL LOTS FOR CONTROL TESTING (7/20/00). BRAUN'S TESTING RESULTS CONCLUDED THAT NO BACTERIAL OR FUNGAL CONTAMINATION WAS PRESENT IN ANY OF THESE SAMPLES. THERE IS NO EVIDENCE THAT INDICATES THAT THESE OCCURRENCES WERE THE RESULT OF ANY STERILITY OR QUALITY DEFICIENCY WITH THIS PRODUCT. |
|
ADVERSE EVENT OR PRODUCT PROBLEM DESCRIPTION |
REPORT DATE: 08/14/2000 MDR TEXT KEY: 999618 Patient Sequence Number: 1 |
THE USER FACILITY REPORTS NINE (9) OCCURRENCES OF STAPH AUREUS INFECTIONS AT THE EPIDURAL CATHETER INSERTION POINT FOLLOWING BACK SURGERIES AND EPIDURALS. THE INFECTION CONTROL GROUP IS INVESTIGATING ALL POTENTIAL SOURCES OF INFECTION, INCLUDING HOSPITAL STAFF, EQUIPMENT, ROOMS, AND PRODUCTS. DURING THIS INVESTIGATION, THE INFECTION CONTROL NURSE DID A GRAM STAIN OF THE CONTENTS OF THE WYETH-AYERST SODIUM CHLORIDE AMPOULE CONTAINED IN A B BRAUN KIT. THE GRAM STAIN TESTED POSITIVE FOR RARE PROTEUS SPECIES AND RARE GRAM POSITIVE COCCI. THIS WAS THE ONLY SAMPLE THE HOSPITAL HAD REMAINING FROM THIS LOT, AND HOSP WAS THEREFORE UNABLE TO PERFORM A RETEST. THE USER FACILITY INDICATED THAT THEY WOULD NOT HAVE NORMALLY CONTACTED THE MFR WITHOUT DOING A RE-TEST FIRST, BUT THEY DID NOT HAVE ANY MORE SAMPLES. THE HOSPITAL ALSO FOUND CONDENSATION IN THE CCU ROOM. THE FACILITY DID NOT PROVIDE ANY SPECIFIC INFO ON HOW THEIR TESTING WAS PERFORMED (I.E., HOW THE SAMPLES WERE HANDLED, STORED, CULTURED, ETC.). THE FACILITY REPORTED TWO DIFFERENT CATALOG NUMBERS (332205 AND 555611), BECAUSE THE FACILITY USES BOTH, BUT THESE EVENTS WERE NOT ATTRIBUTED TO EITHER CATALOG NUMBER SPECIFICALLY. B. BRAUN TESTED SAMPLES FROM THE REPORTED LOT OF SODIUM CHLORIDE (WYETH LOT #119095) WITH NEGATIVE RESULTS. THESE EVENTS ARE ISOLATED TO THIS FACILITY. THERE HAVE BEEN NO OTHER OCCURRENCES OF THIS NATURE REPORTED FROM ANY OTHER FACILITIES USING THESE PRODUCTS. THERE IS NO FURTHER INFO AVAILABLE ON THE PT'S STATUS. |
40.
BRAND NAME |
PERIFIX |
||||
TYPE OF DEVICE |
PERIFIX CONTINUOUS EPIDURAL SET |
||||
BASELINE BRAND NAME |
PERIFIX |
||||
BASELINE GENERIC NAME |
PERIFIX CONTINUOUS EPIDURAL SET |
||||
BASELINE CATALOGUE NUMBER |
332205 |
||||
BASELINE MODEL NUMBER |
CE18C |
||||
MANUFACTURER (Section F) |
|
||||
MANUFACTURER (Section D) |
|
||||
MANUFACTURER CONTACT |
|
||||
DEVICE EVENT KEY |
281976 |
||||
MDR REPORT KEY |
291347 |
||||
EVENT KEY |
273495 |
||||
REPORT NUMBER |
2523676-2000-00026 |
||||
DEVICE SEQUENCE NUMBER |
1 |
||||
PRODUCT CODE |
CAZ |
||||
REPORT SOURCE |
MANUFACTURER |
||||
SOURCE TYPE |
USER FACILITY |
||||
REMEDIAL ACTION |
OTHER |
||||
EVENT TYPE |
INJURY |
||||
TYPE OF REPORT |
INITIAL |
||||
REPORT DATE |
08/14/2000 |
||||
1 DEVICE WAS INVOLVED IN THE EVENT |
|
||||
1 PATIENT WAS INVOLVED IN THE EVENT |
|
||||
DATE FDA RECEIVED |
08/16/2000 |
||||
IS THIS AN ADVERSE EVENT REPORT? |
YES |
||||
IS THIS A PRODUCT PROBLEM REPORT? |
NO |
||||
DEVICE OPERATOR |
HEALTH PROFESSIONAL |
||||
DEVICE EXPIRATION DATE |
11/01/2004 |
||||
DEVICE MODEL NUMBER |
CE18C |
||||
DEVICE CATALOGUE NUMBER |
332205 |
||||
DEVICE LOT NUMBER |
60072518 |
||||
WAS DEVICE AVAILABLE FOR EVALUATION? |
NO |
||||
IS THE REPORTER A HEALTH PROFESSIONAL? |
YES |
||||
WAS THE REPORT SENT TO FDA? |
NO |
||||
DEVICE AGE |
UNKNOWN |
||||
EVENT LOCATION |
HOSPITAL |
||||
DATE MANUFACTURER RECEIVED |
07/13/2000 |
||||
WAS DEVICE EVALUATED BY MANUFACTURER? |
DEVICE NOT RETURNED TO MANUFACTURER |
||||
DATE DEVICE MANUFACTURED |
06/01/2000 |
||||
IS THE DEVICE SINGLE USE? |
YES |
||||
TYPE OF DEVICE USAGE |
UNKNOWN |
||||
PATIENT OUTCOME |
OTHER |
ADVERSE EVENT OR PRODUCT PROBLEM DESCRIPTION |
REPORT DATE: 08/14/2000 MDR TEXT KEY: 999620 Patient Sequence Number: 1 |
THE USER FACILITY REPORTS NINE (9) OCCURRENCES OF STAPH AUREUS INFECTIONS AT THE EPIDURAL CATHETER INSERTION POINT FOLLOWING BACK SURGERIES AND EPIDURALS. THE INFECTION CONTROL GROUP IS INVESTIGATING ALL POTENTIAL SOURCES OF INFECTION, INCLUDING HOSPITAL STAFF, EQUIPMENT, ROOMS, AND PRODUCTS. DURING THIS INVESTIGATION, THE INFECTION CONTROL NURSE DID A GRAM STAIN OF THE CONTENTS OF THE WYETH-AYERST SODIUM CHLORIDE AMPOULE CONTAINED IN A B BRAUN KIT. THE GRAM STAIN TESTED POSITIVE FOR RARE PROTEUS SPECIES AND RARE GRAM POSITIVE COCCI. THIS WAS THE ONLY SAMPLE THE HOSPITAL HAD REMAINING FROM THIS LOT, AND HOSP WAS THEREFORE UNABLE TO PERFORM A RETEST. THE USER FACILITY INDICATED THAT THEY WOULD NOT HAVE NORMALLY CONTACTED THE MFR WITHOUT DOING A RE-TEST FIRST, BUT THEY DID NOT HAVE ANY MORE SAMPLES. THE HOSPITAL ALSO FOUND CONDENSATION IN THE CCU ROOM. THE FACILITY DID NOT PROVIDE ANY SPECIFIC INFO ON HOW THEIR TESTING WAS PERFORMED (I.E., HOW THE SAMPLES WERE HANDLED, STORED, CULTURED, ETC.). THE FACILITY REPORTED TWO DIFFERENT CATALOG NUMBERS (332205 AND 555611), BECAUSE THE FACILITY USES BOTH, BUT THESE EVENTS WERE NOT ATTRIBUTED TO EITHER CATALOG NUMBER SPECIFICALLY. B. BRAUN TESTED SAMPLES FROM THE REPORTED LOT OF SODIUM CHLORIDE (WYETH LOT #119095) WITH NEGATIVE RESULTS. THESE EVENTS ARE ISOLATED TO THIS FACILITY. THERE HAVE BEEN NO OTHER OCCURRENCES OF THIS NATURE REPORTED FROM ANY OTHER FACILITIES USING THESE PRODUCTS. THERE IS NO FURTHER INFO AVAILABLE ON THE PT'S STATUS. |
|
ADDITIONAL MANUFACTURER NARRATIVE |
REPORT DATE: 08/16/2000 MDR TEXT KEY: 999621 |
THERE WERE NO KITS OF THE REPORTED LOT AVAILABLE FOR TESTING, BUT KITS CONTAINING THE SAME LOT OF SODIUM CHLORIDE (WYETH LOT #119095) WERE RETRIEVED FROM INVENTORY AND TESTED. ONE CASE WAS SENT TO WYETH-AYERST FOR TESTING, AND ONE WAS TESTED AT B. BRAUN'S MICROBIOLOGY LAB ALONG WITH TWO ADDITIONAL LOTS FOR CONTROL TESTING (7/20/00). BRAUN'S TESTING RESULTS CONCLUDED THAT NO BACTERIAL OR FUNGAL CONTAMINATION WAS PRESENT IN ANY OF THESE SAMPLES. THERE IS NO EVIDENCE THAT INDICATES THAT THESE OCCURRENCES WERE THE RESULT OF ANY STERILITY OR QUALITY DEFICIENCY WITH THIS PRODUCT. |
41.
BRAND NAME |
PERIFIX |
||||
TYPE OF DEVICE |
PERIFIX CONTINUOUS EPIDURAL SET |
||||
BASELINE BRAND NAME |
PERIFIX |
||||
BASELINE GENERIC NAME |
PERIFIX CONTINUOUS EPIDURAL SET |
||||
BASELINE CATALOGUE NUMBER |
332205 |
||||
BASELINE MODEL NUMBER |
CE18C |
||||
MANUFACTURER (Section F) |
|
||||
MANUFACTURER (Section D) |
|
||||
MANUFACTURER CONTACT |
|
||||
DEVICE EVENT KEY |
281979 |
||||
MDR REPORT KEY |
291350 |
||||
EVENT KEY |
273497 |
||||
REPORT NUMBER |
2523676-2000-00027 |
||||
DEVICE SEQUENCE NUMBER |
1 |
||||
PRODUCT CODE |
CAZ |
||||
REPORT SOURCE |
MANUFACTURER |
||||
SOURCE TYPE |
USER FACILITY |
||||
REMEDIAL ACTION |
OTHER |
||||
EVENT TYPE |
INJURY |
||||
TYPE OF REPORT |
INITIAL |
||||
REPORT DATE |
08/14/2000 |
||||
1 DEVICE WAS INVOLVED IN THE EVENT |
|
||||
1 PATIENT WAS INVOLVED IN THE EVENT |
|
||||
DATE FDA RECEIVED |
08/16/2000 |
||||
IS THIS AN ADVERSE EVENT REPORT? |
YES |
||||
IS THIS A PRODUCT PROBLEM REPORT? |
NO |
||||
DEVICE OPERATOR |
HEALTH PROFESSIONAL |
||||
DEVICE EXPIRATION DATE |
11/01/2004 |
||||
DEVICE MODEL NUMBER |
CE18C |
||||
DEVICE CATALOGUE NUMBER |
332205 |
||||
DEVICE LOT NUMBER |
60072518 |
||||
WAS DEVICE AVAILABLE FOR EVALUATION? |
NO |
||||
IS THE REPORTER A HEALTH PROFESSIONAL? |
YES |
||||
WAS THE REPORT SENT TO FDA? |
NO |
||||
DEVICE AGE |
UNKNOWN |
||||
EVENT LOCATION |
HOSPITAL |
||||
DATE MANUFACTURER RECEIVED |
07/13/2000 |
||||
WAS DEVICE EVALUATED BY MANUFACTURER? |
DEVICE NOT RETURNED TO MANUFACTURER |
||||
DATE DEVICE MANUFACTURED |
06/01/2000 |
||||
IS THE DEVICE SINGLE USE? |
YES |
||||
TYPE OF DEVICE USAGE |
UNKNOWN |
||||
PATIENT OUTCOME |
OTHER |
ADVERSE EVENT OR PRODUCT PROBLEM DESCRIPTION |
REPORT DATE: 08/14/2000 MDR TEXT KEY: 999630 Patient Sequence Number: 1 |
THE USER FACILITY REPORTS NINE (9) OCCURRENCES OF STAPH AUREUS INFECTIONS AT THE EPIDURAL CATHETER INSERTION POINT FOLLOWING BACK SURGERIES AND EPIDURALS. THE INFECTION CONTROL GROUP IS INVESTIGATING ALL POTENTIAL SOURCES OF INFECTION, INCLUDING HOSPITAL STAFF, EQUIPMENT, ROOMS, AND PRODUCTS. DURING THIS INVESTIGATION, THE INFECTION CONTROL NURSE DID A GRAM STAIN OF THE CONTENTS OF THE WYETH-AYERST SODIUM CHLORIDE AMPOULE CONTAINED IN A B BRAUN KIT. THE GRAM STAIN TESTED POSITIVE FOR RARE PROTEUS SPECIES AND RARE GRAM POSITIVE COCCI. THIS WAS THE ONLY SAMPLE THE HOSPITAL HAD REMAINING FROM THIS LOT, AND HOSP WAS THEREFORE UNABLE TO PERFORM A RETEST. THE USER FACILITY INDICATED THAT THEY WOULD NOT HAVE NORMALLY CONTACTED THE MFR WITHOUT DOING A RE-TEST FIRST, BUT THEY DID NOT HAVE ANY MORE SAMPLES. THE HOSPITAL ALSO FOUND CONDENSATION IN THE CCU ROOM. THE FACILITY DID NOT PROVIDE ANY SPECIFIC INFO ON HOW THEIR TESTING WAS PERFORMED (I.E., HOW THE SAMPLES WERE HANDLED, STORED, CULTURED, ETC.). THE FACILITY REPORTED TWO DIFFERENT CATALOG NUMBERS (332205 AND 555611), BECAUSE THE FACILITY USES BOTH, BUT THESE EVENTS WERE NOT ATTRIBUTED TO EITHER CATALOG NUMBER SPECIFICALLY. B. BRAUN TESTED SAMPLES FROM THE REPORTED LOT OF SODIUM CHLORIDE (WYETH LOT #119095) WITH NEGATIVE RESULTS. THESE EVENTS ARE ISOLATED TO THIS FACILITY. THERE HAVE BEEN NO OTHER OCCURRENCES OF THIS NATURE REPORTED FROM ANY OTHER FACILITIES USING THESE PRODUCTS. THERE IS NO FURTHER INFO AVAILABLE ON THE PT'S STATUS. |
|
ADDITIONAL MANUFACTURER NARRATIVE |
REPORT DATE: 08/14/2000 MDR TEXT KEY: 999631 |
THERE WERE NO KITS OF THE REPORTED LOT AVAILABLE FOR TESTING, BUT KITS CONTAINING THE SAME LOT OF SODIUM CHLORIDE (WYETH LOT#119095) WERE RETRIEVED FROM INVENTORY AND TESTED. ONE CASE WAS SENT TO WYETH-AYERST FOR TESTING, AND ONE WAS TESTED AT B. BRAUN'S MICROBIOLOGY LAB ALONG WITH TWO ADDITIONAL LOTS FOR CONTROL TESTING (7/20/00). BRAUN'S TESTING RESULTS CONCLUDED THAT NO BACTERIAL OR FUNGAL CONTAMINATION WAS PRESENT IN ANY OF THESE SAMPLES. THERE IS NO EVIDENCE THAT INDICATES THAT THESE OCCURRENCES WERE THE RESULT OF ANY STERILITY OR QUALITY DEFICIENCY WITH THIS PRODUCT. |
42.
BRAND NAME |
PERIFIX |
||||
TYPE OF DEVICE |
PERIFIX CUSTOM SOFT TIP EPIDURAL TRAY |
||||
BASELINE BRAND NAME |
PERIFIX |
||||
BASELINE GENERIC NAME |
SOFT TIP EPIDURAL CATH |
||||
BASELINE CATALOGUE NUMBER |
332082 |
||||
BASELINE MODEL NUMBER |
CE17TKST |
||||
BASELINE DEVICE FAMILY |
CONTINUOUS EPIDURAL KITS |
||||
BASELINE DEVICE 510(K) NUMBER |
K840179 |
||||
BASELINE SHELF LIFE INFORMATION |
YES |
||||
IS BASELINE PMA NUMBER PROVIDED?</< TH> |
NO |
||||
BASELINE PREAMENDMENT? |
NO |
||||
TRANSITIONAL? |
NO |
||||
510(K) EXEMPT? |
NO |
||||
SHELF LIFE(Months) |
12 |
||||
DATE FIRST MARKETED |
02/24/1984 |
||||
MANUFACTURER (Section F) |
|
||||
MANUFACTURER (Section D) |
|
||||
MANUFACTURER CONTACT |
|
||||
DEVICE EVENT KEY |
278952 |
||||
MDR REPORT KEY |
288254 |
||||
EVENT KEY |
270484 |
||||
REPORT NUMBER |
2523676-2000-00015 |
||||
DEVICE SEQUENCE NUMBER |
1 |
||||
PRODUCT CODE |
CAZ |
||||
REPORT SOURCE |
MANUFACTURER |
||||
SOURCE TYPE |
HEALTH PROFESSIONAL |
||||
REMEDIAL ACTION |
OTHER |
||||
EVENT TYPE |
OTHER |
||||
TYPE OF REPORT |
INITIAL |
||||
REPORT DATE |
07/20/2000 |
||||
1 DEVICE WAS INVOLVED IN THE EVENT |
|
||||
1 PATIENT WAS INVOLVED IN THE EVENT |
|
||||
DATE FDA RECEIVED |
08/01/2000 |
||||
IS THIS AN ADVERSE EVENT REPORT? |
YES |
||||
IS THIS A PRODUCT PROBLEM REPORT? |
NO |
||||
DEVICE OPERATOR |
HEALTH PROFESSIONAL |
||||
DEVICE MODEL NUMBER |
CE17TKST |
||||
DEVICE CATALOGUE NUMBER |
332082 |
||||
WAS DEVICE AVAILABLE FOR EVALUATION? |
NO |
||||
IS THE REPORTER A HEALTH PROFESSIONAL? |
YES |
||||
WAS THE REPORT SENT TO FDA? |
NO |
||||
DISTRIBUTOR FACILITY AWARE DATE |
06/20/2000 |
||||
DEVICE AGE |
UNKNOWN |
||||
EVENT LOCATION |
HOSPITAL |
||||
DATE MANUFACTURER RECEIVED |
06/20/2000 |
||||
WAS DEVICE EVALUATED BY MANUFACTURER? |
DEVICE NOT RETURNED TO MANUFACTURER |
||||
IS THE DEVICE SINGLE USE? |
YES |
||||
TYPE OF DEVICE USAGE |
INITIAL |
||||
PATIENT OUTCOME |
REQUIRED INTERVENTION |
ADVERSE EVENT OR PRODUCT PROBLEM DESCRIPTION |
REPORT DATE: 07/20/2000 MDR TEXT KEY: 988701 Patient Sequence Number: 1 |
DR PLACED A CATHETER IN PT FOR LABOR AND DELIVERY IN 2000. THE CATHETER WAS PLACED LESS THAN 24 HRS. PT WAS DISCHARGED. PT RETURNED TO EMERGENCY ROOM ON FOLLOWING WEEKEND WITH CHILLS & FEVER. PT WAS SENT HOME SINCE THE DIAGNOSIS WAS NOT CLEAR AT THAT TIME. PT RETURNED TO EMERGENCY ROOM ON TUESDAY, 6/13/2000 WITH CHILLS & FEVER, AND SOME NEUROLOGICAL SIGNS. HAD DEBRIDEMENT SURGERY AND IS DOING FINE. |
|
ADDITIONAL MANUFACTURER NARRATIVE |
REPORT DATE: 07/20/2000 MDR TEXT KEY: 988704 |
NO CONCLUSION CAN BE DRAWN SINCE DEVICE WAS NOT RETURNED FOR EVAL. TO DATE, THE MFR HAS REC'D NO OTHER REPORTS OF THIS NATURE FOR THIS PRODUCT. THERE IS NO EVIDENCE TO SUGGEST THAT THIS PRODUCT CAUSED OR CONTRIBUTED TO THIS EVENT. NO FURTHER INFO IS AVAILABLE ON THE PT'S STATUS. |
43.
BRAND NAME |
PERIFIX |
||||
TYPE OF DEVICE |
PERIFIX CONTINUOUS EPIDURAL TRAY |
||||
BASELINE BRAND NAME |
PERIFIX |
||||
BASELINE GENERIC NAME |
CONTINUOUS EPIDURAL TRAY |
||||
BASELINE CATALOGUE NUMBER |
332220 |
||||
BASELINE MODEL NUMBER |
CE18TK |
||||
BASELINE DEVICE FAMILY |
CONTINUOUS EPIDURAL KIT |
||||
BASELINE DEVICE 510(K) NUMBER |
K840179 |
||||
BASELINE SHELF LIFE INFORMATION |
YES |
||||
IS BASELINE PMA NUMBER PROVIDED?</< TH> |
NO |
||||
BASELINE PREAMENDMENT? |
NO |
||||
TRANSITIONAL? |
NO |
||||
510(K) EXEMPT? |
NO |
||||
SHELF LIFE(Months) |
12 |
||||
DATE FIRST MARKETED |
02/24/1984 |
||||
MANUFACTURER (Section F) |
|
||||
MANUFACTURER (Section D) |
|
||||
MANUFACTURER CONTACT |
|
||||
DEVICE EVENT KEY |
278945 |
||||
MDR REPORT KEY |
288247 |
||||
EVENT KEY |
270477 |
||||
REPORT NUMBER |
2523676-2000-00017 |
||||
DEVICE SEQUENCE NUMBER |
1 |
||||
PRODUCT CODE |
CAZ |
||||
REPORT SOURCE |
MANUFACTURER |
||||
SOURCE TYPE |
HEALTH PROFESSIONAL |
||||
REMEDIAL ACTION |
OTHER |
||||
EVENT TYPE |
INJURY |
||||
TYPE OF REPORT |
INITIAL |
||||
REPORT DATE |
07/24/2000 |
||||
1 DEVICE WAS INVOLVED IN THE EVENT |
|
||||
1 PATIENT WAS INVOLVED IN THE EVENT |
|
||||
DATE FDA RECEIVED |
08/01/2000 |
||||
IS THIS AN ADVERSE EVENT REPORT? |
YES |
||||
IS THIS A PRODUCT PROBLEM REPORT? |
NO |
||||
DEVICE OPERATOR |
HEALTH PROFESSIONAL |
||||
DEVICE EXPIRATION DATE |
08/30/2000 |
||||
DEVICE MODEL NUMBER |
CE18TK |
||||
DEVICE CATALOGUE NUMBER |
332220 |
||||
DEVICE LOT NUMBER |
60011371 |
||||
WAS DEVICE AVAILABLE FOR EVALUATION? |
YES |
||||
IS THE REPORTER A HEALTH PROFESSIONAL? |
YES |
||||
WAS THE REPORT SENT TO FDA? |
YES |
||||
DISTRIBUTOR FACILITY AWARE DATE |
06/20/2000 |
||||
DEVICE AGE |
4 YR |
||||
EVENT LOCATION |
HOSPITAL |
||||
DATE MANUFACTURER RECEIVED |
06/20/2000 |
||||
WAS DEVICE EVALUATED BY MANUFACTURER? |
YES |
||||
DATE DEVICE MANUFACTURED |
05/01/2000 |
||||
IS THE DEVICE SINGLE USE? |
YES |
||||
TYPE OF DEVICE USAGE |
INITIAL |
||||
PATIENT OUTCOME |
REQUIRED INTERVENTION |
ADVERSE EVENT OR PRODUCT PROBLEM DESCRIPTION |
REPORT DATE: 07/24/2000 MDR TEXT KEY: 988678 Patient Sequence Number: 1 |
CATHETER TIP SHEARED. APPROXIMATELY 1 INCH MISSING FROM TIP. |
|
ADDITIONAL MANUFACTURER NARRATIVE |
REPORT DATE: 07/24/2000 MDR TEXT KEY: 988681 |
A VISUAL INSPECTION OF THE CATHETER FOUND THAT THE TIP EXHIBITED, A CLEAN ANGULAR CUT, WITH NO EVIDENT STRATING OR ELONGATION. THE CATHETER APPEARED TO BE SHEARED. IT SHOULD BE NOTED THAT THE LABELING ON THE TRAY STATES, "DO NOT WITHDRAW CATHETER THROUGH THE NEEDLE BECAUSE OF POSSIBLE DANGER OF SHEARING". NO FURTHER INFO IS AVAILABLE ON THE PT'S STATUS. |
44.
BRAND NAME |
PERIFIX |
|||
TYPE OF DEVICE |
PERIFIX EPIDURAL CATHETERS |
|||
BASELINE BRAND NAME |
PERIFIX |
|||
BASELINE GENERIC NAME |
PERIFIX EPIDURAL CATHETERS |
|||
BASELINE CATALOGUE NUMBER |
333500 |
|||
BASELINE MODEL NUMBER |
EC18-O |
|||
MANUFACTURER (Section D) |
|
|||
DEVICE EVENT KEY |
276694 |
|||
MDR REPORT KEY |
285931 |
|||
EVENT KEY |
268259 |
|||
REPORT NUMBER |
285931 |
|||
DEVICE SEQUENCE NUMBER |
1 |
|||
PRODUCT CODE |
BSO |
|||
REPORT SOURCE |
USER FACILITY |
|||
TYPE OF REPORT |
INITIAL |
|||
REPORT DATE |
07/10/2000,07/07/2000 |
|||
1 DEVICE WAS INVOLVED IN THE EVENT |
|
|||
1 PATIENT WAS INVOLVED IN THE EVENT |
|
|||
DATE FDA RECEIVED |
07/13/2000 |
|||
IS THIS AN ADVERSE EVENT REPORT? |
YES |
|||
IS THIS A PRODUCT PROBLEM REPORT? |
NO |
|||
DEVICE OPERATOR |
HEALTH PROFESSIONAL |
|||
DEVICE MODEL NUMBER |
EC18-O |
|||
DEVICE CATALOGUE NUMBER |
333500 |
|||
WAS DEVICE AVAILABLE FOR EVALUATION? |
NO |
|||
IS THE REPORTER A HEALTH PROFESSIONAL? |
YES |
|||
WAS THE REPORT SENT TO FDA? |
NO |
|||
DISTRIBUTOR FACILITY AWARE DATE |
01/18/2000 |
|||
DEVICE AGE |
UNKNOWN |
|||
EVENT LOCATION |
HOSPITAL |
|||
PATIENT OUTCOME |
OTHER |
ADVERSE EVENT OR PRODUCT PROBLEM DESCRIPTION |
REPORT DATE: 07/10/2000 MDR TEXT KEY: 980217 Patient Sequence Number: 1 |
THE MEDWATCH REPORT RECEIVED FROM THE USER FACILITY STATES: "THE TIP OF EPIDURAL CATHETER BROKE OFF WHEN TRYING TO PULL BACK ON CATHETER." |
45.
BRAND NAME |
PERIFIX |
|||
TYPE OF DEVICE |
CONTINUOUS EPIDURAL CATHETER |
|||
MANUFACTURER (Section F) |
|
|||
MANUFACTURER (Section D) |
|
|||
DEVICE EVENT KEY |
266864 |
|||
MDR REPORT KEY |
275712 |
|||
EVENT KEY |
258504 |
|||
REPORT NUMBER |
275712 |
|||
DEVICE SEQUENCE NUMBER |
1 |
|||
PRODUCT CODE |
BSO |
|||
REPORT SOURCE |
USER FACILITY |
|||
TYPE OF REPORT |
INITIAL |
|||
REPORT DATE |
04/26/2000 |
|||
1 DEVICE WAS INVOLVED IN THE EVENT |
|
|||
1 PATIENT WAS INVOLVED IN THE EVENT |
|
|||
DATE FDA RECEIVED |
04/27/2000 |
|||
IS THIS AN ADVERSE EVENT REPORT? |
NO |
|||
IS THIS A PRODUCT PROBLEM REPORT? |
YES |
|||
DEVICE OPERATOR |
HEALTH PROFESSIONAL |
|||
DEVICE EXPIRATION DATE |
05/01/2002 |
|||
DEVICE MODEL NUMBER |
CE-18HK |
|||
DEVICE CATALOGUE NUMBER |
332230 |
|||
DEVICE LOT NUMBER |
60080798 |
|||
WAS DEVICE AVAILABLE FOR EVALUATION? |
YES |
|||
IS THE REPORTER A HEALTH PROFESSIONAL? |
NO ANSWER PROVIDED |
|||
WAS THE REPORT SENT TO FDA? |
NO |
|||
DISTRIBUTOR FACILITY AWARE DATE |
04/24/2000 |
|||
EVENT LOCATION |
HOSPITAL |
|||
DATE REPORT TO MANUFACTURER |
04/26/2000 |
|||
PATIENT OUTCOME |
REQUIRED INTERVENTION |
ADVERSE EVENT OR PRODUCT PROBLEM DESCRIPTION |
REPORT DATE: 04/26/2000 MDR TEXT KEY: 941428 Patient Sequence Number: 1 |
BLACK TIP WAS MISSING FROM EPIDURAL CATHETER UPON REMOVAL. EPIDURAL CATHETER FRACTURED AT TIME OF REMOVAL AND BLACK TIP NOT INTACT. |
|
46.
BRAND NAME |
PERIFIX |
||||
TYPE OF DEVICE |
PERIFIX CONTINUOUS EPIDURAL CUSTOM TRAY |
||||
BASELINE BRAND NAME |
PERIFIX |
||||
BASELINE GENERIC NAME |
CUSTOM EPIDURAL TRAY |
||||
BASELINE CATALOGUE NUMBER |
555861 |
||||
BASELINE MODEL NUMBER |
CESK |
||||
BASELINE DEVICE FAMILY |
CONTINUOUS EPIDURAL TRAYS |
||||
BASELINE DEVICE 510(K) NUMBER |
K813186 |
||||
BASELINE SHELF LIFE INFORMATION |
YES |
||||
IS BASELINE PMA NUMBER PROVIDED?</< TH> |
NO |
||||
BASELINE PREAMENDMENT? |
NO |
||||
TRANSITIONAL? |
NO |
||||
510(K) EXEMPT? |
NO |
||||
SHELF LIFE(Months) |
12 |
||||
DATE FIRST MARKETED |
12/03/1981 |
||||
MANUFACTURER (Section F) |
|
||||
MANUFACTURER (Section D) |
|
||||
MANUFACTURER CONTACT |
|
||||
DEVICE EVENT KEY |
265894 |
||||
MDR REPORT KEY |
274707 |
||||
EVENT KEY |
257551 |
||||
REPORT NUMBER |
2523676-2000-00006 |
||||
DEVICE SEQUENCE NUMBER |
1 |
||||
PRODUCT CODE |
CAZ |
||||
REPORT SOURCE |
MANUFACTURER |
||||
SOURCE TYPE |
USER FACILITY |
||||
REMEDIAL ACTION |
OTHER |
||||
EVENT TYPE |
INJURY |
||||
TYPE OF REPORT |
INITIAL |
||||
REPORT DATE |
04/20/2000 |
||||
1 DEVICE WAS INVOLVED IN THE EVENT |
|
||||
1 PATIENT WAS INVOLVED IN THE EVENT |
|
||||
DATE FDA RECEIVED |
04/20/2000 |
||||
IS THIS AN ADVERSE EVENT REPORT? |
YES |
||||
IS THIS A PRODUCT PROBLEM REPORT? |
NO |
||||
DEVICE OPERATOR |
HEALTH PROFESSIONAL |
||||
DEVICE EXPIRATION DATE |
05/31/2002 |
||||
DEVICE MODEL NUMBER |
CESK |
||||
DEVICE CATALOGUE NUMBER |
555215 |
||||
DEVICE LOT NUMBER |
60079493 |
||||
WAS DEVICE AVAILABLE FOR EVALUATION? |
DEVICE NOT RETURNED TO MANUFACTURER |
||||
DATE RETURNED TO MANUFACTURER |
03/15/2000 |
||||
IS THE REPORTER A HEALTH PROFESSIONAL? |
YES |
||||
WAS THE REPORT SENT TO FDA? |
NO |
||||
DEVICE AGE |
1 YR |
||||
EVENT LOCATION |
HOSPITAL |
||||
DATE MANUFACTURER RECEIVED |
03/15/2000 |
||||
WAS DEVICE EVALUATED BY MANUFACTURER? |
YES |
||||
DATE DEVICE MANUFACTURED |
12/01/1999 |
||||
IS THE DEVICE SINGLE USE? |
YES |
||||
TYPE OF DEVICE USAGE |
UNKNOWN |
||||
PATIENT OUTCOME |
REQUIRED INTERVENTION |
ADVERSE EVENT OR PRODUCT PROBLEM DESCRIPTION |
REPORT DATE: 04/20/2000 MDR TEXT KEY: 937609 Patient Sequence Number: 1 |
EPIDURAL CATHETER BROKE INTO TWO PIECES. APPROXIMATELY 2 CM REMAINS IN THE PT. |
|
ADDITIONAL MANUFACTURER NARRATIVE |
REPORT DATE: 04/20/2000 MDR TEXT KEY: 937612 |
A VISUAL INSPECTION OF THE CATHETER FOUND THAT THE TIP EXHIBITED, A CLEAN ANGULAR CUT, WITH NO EVIDENT STRETCHING OR ELONGATION. THE CATHETER APPEARED TO BE SHEARED. IT SHOULD BE NOTED THAT THE LABELING ON THE TRAY STATES, "DO NOT WITHDRAW CATHETER THROUGH THE NEEDLE BECAUSE OF POSSIBLE DANGER OF SHEARING". NO FURTHER INFO IS AVAILABLE ON THE PT'S STATUS. |
47.
BRAND NAME |
PERIFIX |
|||
TYPE OF DEVICE |
CUSTOM EPIDURAL ANESTHESIA TRAY |
|||
MANUFACTURER (Section D) |
|
|||
DEVICE EVENT KEY |
264821 |
|||
MDR REPORT KEY |
273570 |
|||
EVENT KEY |
256488 |
|||
REPORT NUMBER |
273570 |
|||
DEVICE SEQUENCE NUMBER |
1 |
|||
PRODUCT CODE |
CAZ |
|||
REPORT SOURCE |
VOLUNTARY |
|||
REPORT DATE |
03/31/2000 |
|||
1 DEVICE WAS INVOLVED IN THE EVENT |
|
|||
1 PATIENT WAS INVOLVED IN THE EVENT |
|
|||
DATE FDA RECEIVED |
04/13/2000 |
|||
IS THIS AN ADVERSE EVENT REPORT? |
NO |
|||
DEVICE OPERATOR |
HEALTH PROFESSIONAL |
|||
DEVICE EXPIRATION DATE |
09/01/2001 |
|||
DEVICE LOT NUMBER |
60070864 |
|||
WAS DEVICE AVAILABLE FOR EVALUATION? |
YES |
ADVERSE EVENT OR PRODUCT PROBLEM DESCRIPTION |
REPORT DATE: 03/31/2000 MDR TEXT KEY: 933426 Patient Sequence Number: 1 |
A 10CC GLASS EPIDURAL SYRINGE SHATTERED DURING NEGATIVE ASPIRATION OF A CONTINUOUS LABOR EPIDURAL PLACEMENT. |
48.
BRAND NAME |
PERIFIX |
||||
TYPE OF DEVICE |
UNK. EPIDURAL CATHETER (NOT A B. BRAUN CAT. NO.) |
||||
BASELINE BRAND NAME |
PERIFIX |
||||
BASELINE GENERIC NAME |
UNK. EPIDURAL CATHETER (NOT A B. BRAUN CAT. NO.) |
||||
BASELINE CATALOGUE NUMBER |
SJ-05501 |
||||
BASELINE MODEL NUMBER |
UNK |
||||
MANUFACTURER (Section F) |
|
||||
MANUFACTURER (Section D) |
|
||||
MANUFACTURER CONTACT |
|
||||
DEVICE EVENT KEY |
263418 |
||||
MDR REPORT KEY |
272105 |
||||
EVENT KEY |
255118 |
||||
REPORT NUMBER |
2523676-2000-00007 |
||||
DEVICE SEQUENCE NUMBER |
1 |
||||
PRODUCT CODE |
BSO |
||||
REPORT SOURCE |
MANUFACTURER |
||||
SOURCE TYPE |
USER FACILITY |
||||
REMEDIAL ACTION |
OTHER |
||||
EVENT TYPE |
INJURY |
||||
TYPE OF REPORT |
INITIAL |
||||
REPORT DATE |
03/30/2000 |
||||
1 DEVICE WAS INVOLVED IN THE EVENT |
|
||||
1 PATIENT WAS INVOLVED IN THE EVENT |
|
||||
DATE FDA RECEIVED |
03/30/2000 |
||||
IS THIS AN ADVERSE EVENT REPORT? |
YES |
||||
IS THIS A PRODUCT PROBLEM REPORT? |
NO |
||||
DEVICE OPERATOR |
HEALTH PROFESSIONAL |
||||
DEVICE CATALOGUE NUMBER |
SJ-05501 |
||||
WAS DEVICE AVAILABLE FOR EVALUATION? |
NO |
||||
IS THE REPORTER A HEALTH PROFESSIONAL? |
NO |
||||
WAS THE REPORT SENT TO FDA? |
NO |
||||
DISTRIBUTOR FACILITY AWARE DATE |
01/31/2000 |
||||
DEVICE AGE |
UNKNOWN |
||||
EVENT LOCATION |
HOSPITAL |
||||
DATE MANUFACTURER RECEIVED |
03/14/2000 |
||||
WAS DEVICE EVALUATED BY MANUFACTURER? |
NO |
||||
IS THE DEVICE SINGLE USE? |
YES |
||||
TYPE OF DEVICE USAGE |
INITIAL |
||||
PATIENT OUTCOME |
REQUIRED INTERVENTION |
ADVERSE EVENT OR PRODUCT PROBLEM DESCRIPTION |
REPORT DATE: 03/30/2000 MDR TEXT KEY: 927628 Patient Sequence Number: 1 |
MEDWATCH REPORT RECEIVED FROM THE FACILITY STATES: EPIDURAL CATHETER ITP WAS NOTED TO BE SHEARED OFF WHEN REMOVED FROM PT. LUMBAR SPINE X-RAYS OF 01/31/2000 AND LUMBAR CT SCAN OF 02/01/2000 WERE NEGATIVE FOR RADIOPAQUE FOREIGN BODIES. THE PT WAS INFORMED OF THE MISSING CATHETER TIP. |
|
ADDITIONAL MANUFACTURER NARRATIVE |
REPORT DATE: 03/30/2000 MDR TEXT KEY: 927631 |
THE SAMPLE IS BEING RETAINED BY THE USER/FACILITY AND WILL NOT BE RELEASED. IT SHOULD BE NOTED THAT THE REPORTED CATALOG NUMBER IS NOT A B. BRAUN CATALOG NUMBER. NO CONCLUSION CAN BE DRAWN, SINCE THE DEVICE WAS NOT RETURNED FOR EVAL. A SUBSEQUENT CT SCAN AND X-RAY DID NOT SHOW ANY CATHETER FRAGMENTS REMAINING IN THE PT. THE PT SUFFERED NO ADVERSE EFFECTS AS A RESULT OF THIS OCCURRENCE. NO FURTHER INFO IS AVAILABLE ON THE PT'S STATUS. IT SHOULD ALSO BE NOTED THAT THE LABELING ON THE TRAY STATES, "DO NOT WITHDRAW CATHETER THROUGH THE NEEDLE." |
49.
BRAND NAME |
PERIFIX |
||||
TYPE OF DEVICE |
PERIFIX CONTINUOUS EPIDURAL CUSTOM TRAY |
||||
BASELINE BRAND NAME |
PERIFIX |
||||
BASELINE GENERIC NAME |
CUSTOM EPIDURAL TRAY |
||||
BASELINE CATALOGUE NUMBER |
555861 |
||||
BASELINE MODEL NUMBER |
CESK |
||||
BASELINE DEVICE FAMILY |
CONTINUOUS EPIDURAL TRAYS |
||||
BASELINE DEVICE 510(K) NUMBER |
K813186 |
||||
BASELINE SHELF LIFE INFORMATION |
YES |
||||
IS BASELINE PMA NUMBER PROVIDED?</< TH> |
NO |
||||
BASELINE PREAMENDMENT? |
NO |
||||
TRANSITIONAL? |
NO |
||||
510(K) EXEMPT? |
NO |
||||
SHELF LIFE(Months) |
12 |
||||
DATE FIRST MARKETED |
12/03/1981 |
||||
MANUFACTURER (Section F) |
|
||||
MANUFACTURER (Section D) |
|
||||
MANUFACTURER CONTACT |
|
||||
DEVICE EVENT KEY |
258106 |
||||
MDR REPORT KEY |
266613 |
||||
EVENT KEY |
249923 |
||||
REPORT NUMBER |
2523676-2000-00002 |
||||
DEVICE SEQUENCE NUMBER |
1 |
||||
PRODUCT CODE |
CAZ |
||||
REPORT SOURCE |
MANUFACTURER |
||||
SOURCE TYPE |
HEALTH PROFESSIONAL,USER FACILITY |
||||
REMEDIAL ACTION |
OTHER |
||||
EVENT TYPE |
INJURY |
||||
TYPE OF REPORT |
INITIAL |
||||
REPORT DATE |
02/29/2000 |
||||
1 DEVICE WAS INVOLVED IN THE EVENT |
|
||||
1 PATIENT WAS INVOLVED IN THE EVENT |
|
||||
DATE FDA RECEIVED |
03/01/2000 |
||||
IS THIS AN ADVERSE EVENT REPORT? |
YES |
||||
IS THIS A PRODUCT PROBLEM REPORT? |
NO |
||||
DEVICE OPERATOR |
HEALTH PROFESSIONAL |
||||
DEVICE EXPIRATION DATE |
05/31/2001 |
||||
DEVICE MODEL NUMBER |
CESK |
||||
DEVICE CATALOGUE NUMBER |
555951 |
||||
DEVICE LOT NUMBER |
60061454 |
||||
WAS DEVICE AVAILABLE FOR EVALUATION? |
DEVICE NOT RETURNED TO MANUFACTURER |
||||
DATE RETURNED TO MANUFACTURER |
02/01/2000 |
||||
IS THE REPORTER A HEALTH PROFESSIONAL? |
YES |
||||
WAS THE REPORT SENT TO FDA? |
NO |
||||
DISTRIBUTOR FACILITY AWARE DATE |
11/26/1999 |
||||
DEVICE AGE |
2 MO |
||||
EVENT LOCATION |
HOSPITAL |
||||
WAS DEVICE EVALUATED BY MANUFACTURER? |
YES |
||||
IS THE DEVICE SINGLE USE? |
YES |
||||
TYPE OF DEVICE USAGE |
INITIAL |
||||
PATIENT OUTCOME |
REQUIRED INTERVENTION |
ADVERSE EVENT OR PRODUCT PROBLEM DESCRIPTION |
REPORT DATE: 02/29/2000 MDR TEXT KEY: 906972 Patient Sequence Number: 1 |
THE EPIDURAL CATHETER FRAGMENTED WITHIN THE PATIENT. THE CATHETER FRAGMENT COULD NOT BE RETREIVED. |
|
ADDITIONAL MANUFACTURER NARRATIVE |
REPORT DATE: 02/29/2000 MDR TEXT KEY: 906975 |
A VISUAL INSPECTION OF THE CATHETER FOUND THAT THE TIP EXHIBITED, A CLEAN ANGULAR CUT, WITH NO EVIDENT STRETCHING OR ELONGATION. THE CATHETER APPEARED TO BE SHEARED. IT SHOULD BE NOTED THAT THE LABELING ON THE TRAY STATES, "DO NOT WITHDRAW CATHETER THROUGH THE NEEDLE BECAUSE OF POSSIBLE DANGER OF SHEARING". NO FURTHER INFORMATION IS AVAILABLE ON THE PATIENT'S STATUS. |
50.
BRAND NAME |
PERIFIX |
||||
TYPE OF DEVICE |
PERIFIX CONTINUOUS EPIDURAL TRAY |
||||
BASELINE BRAND NAME |
PERIFIX |
||||
BASELINE GENERIC NAME |
CONTINUOUS EPIDURAL TRAY |
||||
BASELINE CATALOGUE NUMBER |
332220 |
||||
BASELINE MODEL NUMBER |
CE18TK |
||||
BASELINE DEVICE FAMILY |
CONTINUOUS EPIDURAL KIT |
||||
BASELINE DEVICE 510(K) NUMBER |
K840179 |
||||
BASELINE SHELF LIFE INFORMATION |
YES |
||||
IS BASELINE PMA NUMBER PROVIDED?</< TH> |
NO |
||||
BASELINE PREAMENDMENT? |
NO |
||||
TRANSITIONAL? |
NO |
||||
510(K) EXEMPT? |
NO |
||||
SHELF LIFE(Months) |
12 |
||||
DATE FIRST MARKETED |
02/24/1984 |
||||
MANUFACTURER (Section F) |
|
||||
MANUFACTURER (Section D) |
|
||||
MANUFACTURER CONTACT |
|
||||
DEVICE EVENT KEY |
252936 |
||||
MDR REPORT KEY |
261165 |
||||
EVENT KEY |
244829 |
||||
REPORT NUMBER |
2523676-2000-00001 |
||||
DEVICE SEQUENCE NUMBER |
1 |
||||
PRODUCT CODE |
CAZ |
||||
REPORT SOURCE |
MANUFACTURER |
||||
SOURCE TYPE |
USER FACILITY |
||||
REMEDIAL ACTION |
OTHER |
||||
EVENT TYPE |
INJURY |
||||
TYPE OF REPORT |
INITIAL |
||||
REPORT DATE |
01/03/2000,02/01/2000 |
||||
1 DEVICE WAS INVOLVED IN THE EVENT |
|
||||
1 PATIENT WAS INVOLVED IN THE EVENT |
|
||||
DATE FDA RECEIVED |
02/03/2000 |
||||
IS THIS AN ADVERSE EVENT REPORT? |
YES |
||||
IS THIS A PRODUCT PROBLEM REPORT? |
NO |
||||
DEVICE OPERATOR |
HEALTH PROFESSIONAL |
||||
DEVICE MODEL NUMBER |
CE18TK |
||||
DEVICE CATALOGUE NUMBER |
332220 |
||||
WAS DEVICE AVAILABLE FOR EVALUATION? |
DEVICE NOT RETURNED TO MANUFACTURER |
||||
DATE RETURNED TO MANUFACTURER |
01/17/2000 |
||||
IS THE REPORTER A HEALTH PROFESSIONAL? |
YES |
||||
WAS THE REPORT SENT TO FDA? |
NO |
||||
DEVICE AGE |
UNKNOWN |
||||
EVENT LOCATION |
HOSPITAL |
||||
DATE MANUFACTURER RECEIVED |
01/04/2000 |
||||
WAS DEVICE EVALUATED BY MANUFACTURER? |
DEVICE NOT RETURNED TO MANUFACTURER |
||||
IS THE DEVICE SINGLE USE? |
YES |
||||
TYPE OF DEVICE USAGE |
UNKNOWN |
||||
PATIENT OUTCOME |
REQUIRED INTERVENTION |
ADVERSE EVENT OR PRODUCT PROBLEM DESCRIPTION |
REPORT DATE: 01/03/2000 MDR TEXT KEY: 888141 Patient Sequence Number: 1 |
EPIDURAL CATHETER STRETCHED UPON ATTEMPTED REMOVAL FROM PT, POST VASCULAR SURGERY - CATHETER FRACTURED - FRAGMENT NOT RETRIEVED. |
|
ADDITIONAL MANUFACTURER NARRATIVE |
REPORT DATE: 02/03/2000 MDR TEXT KEY: 888144 |
THE RETURNED SAMPLE DID NOT EXHIBIT ANY VISIBLE MANUFACTURING RELATED DEFECTS. THE CATHETER SAMPLE WAS STRETCHED AND ELONGATED, WHICH INDICATES THAT THE CATHETER HAD BECOME LODGED BETWEEN TWO RIGID BODY STRUCTURES, AND STRETCHED BEYOND IT'S INTENDED DESIGN CAPABILITIES DURING REMOVAL. THIS OCCURRENCE DOES NOT APPEAR TO BE THE RESULT OF A PRODUCT QUALITY DEFICIENCY OR PRODUCT MALFUNCTION. IT SHOULD ALSO BE NOTED THAT THE LABELING ON THE TRAY STATES, "DO NOT WITHDRAW CATHETER THROUGH THE NEEDLE BECAUSE OF POSSIBLE DANGER OF SHEARING". NO FURTHER INFO IS AVAILABLE ON THE PT'S STATUS. |
51.
BRAND NAME |
PERIFIX |
||||
TYPE OF DEVICE |
PERIFIX CONTINUOUS EPIDURAL TRAY |
||||
BASELINE BRAND NAME |
PERIFIX |
||||
BASELINE GENERIC NAME |
CONTINUOUS EPIDURAL TRAY |
||||
BASELINE CATALOGUE NUMBER |
332220 |
||||
BASELINE MODEL NUMBER |
CE18TK |
||||
BASELINE DEVICE FAMILY |
CONTINUOUS EPIDURAL KIT |
||||
BASELINE DEVICE 510(K) NUMBER |
K840179 |
||||
BASELINE SHELF LIFE INFORMATION |
YES |
||||
IS BASELINE PMA NUMBER PROVIDED?</< TH> |
NO |
||||
BASELINE PREAMENDMENT? |
NO |
||||
TRANSITIONAL? |
NO |
||||
510(K) EXEMPT? |
NO |
||||
SHELF LIFE(Months) |
12 |
||||
DATE FIRST MARKETED |
02/24/1984 |
||||
MANUFACTURER (Section F) |
|
||||
MANUFACTURER (Section D) |
|
||||
MANUFACTURER CONTACT |
|
||||
DEVICE EVENT KEY |
249653 |
||||
MDR REPORT KEY |
257808 |
||||
EVENT KEY |
241633 |
||||
REPORT NUMBER |
2523676-1999-00037 |
||||
DEVICE SEQUENCE NUMBER |
1 |
||||
PRODUCT CODE |
CAZ |
||||
REPORT SOURCE |
MANUFACTURER |
||||
SOURCE TYPE |
USER FACILITY |
||||
REMEDIAL ACTION |
OTHER |
||||
EVENT TYPE |
INJURY |
||||
TYPE OF REPORT |
INITIAL |
||||
REPORT DATE |
10/27/1999 |
||||
1 DEVICE WAS INVOLVED IN THE EVENT |
|
||||
1 PATIENT WAS INVOLVED IN THE EVENT |
|
||||
DATE FDA RECEIVED |
01/05/2000 |
||||
IS THIS AN ADVERSE EVENT REPORT? |
YES |
||||
IS THIS A PRODUCT PROBLEM REPORT? |
NO |
||||
DEVICE OPERATOR |
HEALTH PROFESSIONAL |
||||
DEVICE EXPIRATION DATE |
07/31/2000 |
||||
DEVICE MODEL NUMBER |
CE18TK |
||||
DEVICE CATALOGUE NUMBER |
332220 |
||||
DEVICE LOT NUMBER |
0060051282 |
||||
WAS DEVICE AVAILABLE FOR EVALUATION? |
NO |
||||
IS THE REPORTER A HEALTH PROFESSIONAL? |
YES |
||||
WAS THE REPORT SENT TO FDA? |
NO |
||||
DISTRIBUTOR FACILITY AWARE DATE |
10/26/1999 |
||||
DEVICE AGE |
1 MO |
||||
EVENT LOCATION |
HOSPITAL |
||||
DATE MANUFACTURER RECEIVED |
12/07/1999 |
||||
WAS DEVICE EVALUATED BY MANUFACTURER? |
DEVICE NOT RETURNED TO MANUFACTURER |
||||
DATE DEVICE MANUFACTURED |
09/01/1999 |
||||
IS THE DEVICE SINGLE USE? |
YES |
||||
TYPE OF DEVICE USAGE |
UNKNOWN |
||||
PATIENT OUTCOME |
REQUIRED INTERVENTION |
ADVERSE EVENT OR PRODUCT PROBLEM DESCRIPTION |
REPORT DATE: 10/27/1999 MDR TEXT KEY: 875293 Patient Sequence Number: 1 |
A SMALL PIECE OF EPIDURAL CATHETER BROKE OFF DURING REMOVAL FROM PATIENT. THE CATHETER WAS DISCARDED, AND THE AMOUNT OF THE CATHETER THAT FRACTURED IS UNKNOWN. THE FRAGMENT WAS LEFT IN PLACE BY THE PHYSICIAN. |
|
ADDITIONAL MANUFACTURER NARRATIVE |
REPORT DATE: 01/05/2000 MDR TEXT KEY: 875296 |
NO CONCLUSION CAN BE DRAWN SINCE THE DEVICE WAS NOT RETURNED FOR EVALUATION. NO FURTHER INFORMATION IS AVAILABLE ON THE PATIENT'S STATUS. IT SHOULD BE NOTED THAT THE LABELING ON THE TRAY STATES, "DO NOT WITHDRAWAL CATHETER THROUGH THE NEEDLE BECAUSE OF POSSIBLE DANGER OF SHEARING". |
52.
BRAND NAME |
PERIFIX |
||||
TYPE OF DEVICE |
PERIFIX CONTINUOUS EPIDURAL TRAY |
||||
MANUFACTURER (Section F) |
|
||||
MANUFACTURER (Section D) |
|
||||
MANUFACTURER CONTACT |
|
||||
DEVICE EVENT KEY |
241427 |
||||
MDR REPORT KEY |
249196 |
||||
EVENT KEY |
233710 |
||||
REPORT NUMBER |
2523676-1999-00035 |
||||
DEVICE SEQUENCE NUMBER |
1 |
||||
PRODUCT CODE |
CAZ |
||||
REPORT SOURCE |
MANUFACTURER |
||||
SOURCE TYPE |
USER FACILITY |
||||
REMEDIAL ACTION |
OTHER |
||||
EVENT TYPE |
INJURY |
||||
TYPE OF REPORT |
INITIAL |
||||
REPORT DATE |
11/02/1999 |
||||
1 DEVICE WAS INVOLVED IN THE EVENT |
|
||||
1 PATIENT WAS INVOLVED IN THE EVENT |
|
||||
DATE FDA RECEIVED |
11/08/1999 |
||||
IS THIS AN ADVERSE EVENT REPORT? |
YES |
||||
IS THIS A PRODUCT PROBLEM REPORT? |
NO |
||||
DEVICE OPERATOR |
HEALTH PROFESSIONAL |
||||
DEVICE EXPIRATION DATE |
04/30/2001 |
||||
DEVICE MODEL NUMBER |
CE18TK |
||||
DEVICE CATALOGUE NUMBER |
332220 |
||||
DEVICE LOT NUMBER |
60026085 |
||||
WAS DEVICE AVAILABLE FOR EVALUATION? |
NO |
||||
IS THE REPORTER A HEALTH PROFESSIONAL? |
YES |
||||
WAS THE REPORT SENT TO FDA? |
NO |
||||
DISTRIBUTOR FACILITY AWARE DATE |
09/12/1999 |
||||
DEVICE AGE |
UNKNOWN |
||||
EVENT LOCATION |
HOSPITAL |
||||
DATE MANUFACTURER RECEIVED |
09/15/1999 |
||||
WAS DEVICE EVALUATED BY MANUFACTURER? |
NO |
||||
IS THE DEVICE SINGLE USE? |
YES |
||||
TYPE OF DEVICE USAGE |
INITIAL |
ADVERSE EVENT OR PRODUCT PROBLEM DESCRIPTION |
REPORT DATE: 11/02/1999 MDR TEXT KEY: 843463 Patient Sequence Number: 1 |
AFTER REPEATED ATTEMPTS TO PLACE THE CATHETER, IT WAS REMOVED THROUGH THE NEEDLE, AND THE TIP WAS SHEARED OFF. AN UNK PORTION OF THE CATHETER REMAINS IN THE PT. THE PHYSICIAN STATED THERE WAS NOT A PROBLEM WITH THE PRODUCT, BUT HE WANTED THE INCIDENT PROPERLY DOCUMENTED. |
|
ADDITIONAL MANUFACTURER NARRATIVE |
REPORT DATE: 11/08/1999 MDR TEXT KEY: 843466 |
THE SAMPLE IS NOT AVAILABLE; HOWEVER, INFO PROVIDED BY THE USER FACILITY INDICATES THAT NO DEVICE MALFUNCTION OCCURRED. NO FURTHER INFO IS AVAILABLE ON PT'S STATUS. IT SHOULD BE NOTED THAT LABELING ON THE TRAY STATES, "DO NOT WITHDRAWAL CATHETER THROUGH THE NEEDLE BECAUSE OF POSSIBLE DANGER OF SHEARING." |
53.
BRAND NAME |
PERIFIX |
|||
TYPE OF DEVICE |
EPIDURAL CATHETER |
|||
MANUFACTURER (Section D) |
|
|||
DEVICE EVENT KEY |
237883 |
|||
MDR REPORT KEY |
245532 |
|||
EVENT KEY |
230326 |
|||
REPORT NUMBER |
245532 |
|||
DEVICE SEQUENCE NUMBER |
1 |
|||
PRODUCT CODE |
BSO |
|||
REPORT SOURCE |
VOLUNTARY |
|||
REPORT DATE |
10/06/1999 |
|||
1 DEVICE WAS INVOLVED IN THE EVENT |
|
|||
1 PATIENT WAS INVOLVED IN THE EVENT |
|
|||
DATE FDA RECEIVED |
10/19/1999 |
|||
IS THIS AN ADVERSE EVENT REPORT? |
NO |
|||
IS THIS A PRODUCT PROBLEM REPORT? |
YES |
|||
DEVICE OPERATOR |
HEALTH PROFESSIONAL |
|||
OTHER DEVICE ID NUMBER |
PRODUCT CODE EC20-C |
|||
WAS DEVICE AVAILABLE FOR EVALUATION? |
NO |
ADVERSE EVENT OR PRODUCT PROBLEM DESCRIPTION |
REPORT DATE: 10/06/1999 MDR TEXT KEY: 828629 Patient Sequence Number: 1 |
PT NOTED PROBLEM. CALLED STAFF INTO ROOM. EPIDURAL CATHETER BROKEN OFF WITH HUB TO SOLUTION TUBING. HEMOSTAT APPLIED TO TUBING UNTIL PHYSICIAN ARRIVED TO REMOVE REMAINDER OF EPIDURAL CATHETER. |
54.
BRAND NAME |
PERIFIX |
|||
TYPE OF DEVICE |
EPIDURAL CATHETER |
|||
BASELINE BRAND NAME |
PERIFIX |
|||
BASELINE GENERIC NAME |
EPIDURAL CATHETER |
|||
BASELINE CATALOGUE NUMBER |
333530 |
|||
BASELINE MODEL NUMBER |
EC20-C |
|||
MANUFACTURER (Section D) |
|
|||
DEVICE EVENT KEY |
237328 |
|||
MDR REPORT KEY |
244963 |
|||
EVENT KEY |
229807 |
|||
REPORT NUMBER |
244963 |
|||
DEVICE SEQUENCE NUMBER |
1 |
|||
PRODUCT CODE |
BSO |
|||
REPORT SOURCE |
USER FACILITY |
|||
TYPE OF REPORT |
INITIAL |
|||
REPORT DATE |
09/16/1999,10/05/1999 |
|||
1 DEVICE WAS INVOLVED IN THE EVENT |
|
|||
1 PATIENT WAS INVOLVED IN THE EVENT |
|
|||
DATE FDA RECEIVED |
10/13/1999 |
|||
IS THIS AN ADVERSE EVENT REPORT? |
YES |
|||
IS THIS A PRODUCT PROBLEM REPORT? |
NO |
|||
DEVICE OPERATOR |
HEALTH PROFESSIONAL |
|||
DEVICE MODEL NUMBER |
EC20-C |
|||
DEVICE CATALOGUE NUMBER |
333530 |
|||
WAS DEVICE AVAILABLE FOR EVALUATION? |
NO |
|||
IS THE REPORTER A HEALTH PROFESSIONAL? |
YES |
|||
WAS THE REPORT SENT TO FDA? |
NO |
|||
DISTRIBUTOR FACILITY AWARE DATE |
09/13/1999 |
|||
DEVICE AGE |
UNKNOWN |
|||
EVENT LOCATION |
HOSPITAL |
|||
DATE REPORT TO MANUFACTURER |
09/20/1999 |
|||
PATIENT OUTCOME |
REQUIRED INTERVENTION |
ADVERSE EVENT OR PRODUCT PROBLEM DESCRIPTION |
REPORT DATE: 09/16/1999 MDR TEXT KEY: 826102 Patient Sequence Number: 1 |
THE MEDWATCH REPORT RECEIVED FROM THE USER FACILITY STATES: "DURING REMOVAL OF THE EPIDURAL CATHETER, THE TIP WAS NOTED NOT TO BE INTACT WITH THE CATHETER. COMPARISON OF A NEW CATHETER INDICATED THAT 2-3 CM OF THE CATHETER TIP WAS MISSING. THOUGHT TO BE RETAINED." |
55.
BRAND NAME |
PERIFIX |
||||
TYPE OF DEVICE |
PERIFIX CONTINUOUS EPIDURAL CUSTOM TRAY |
||||
BASELINE BRAND NAME |
PERIFIX |
||||
BASELINE GENERIC NAME |
CUSTOM EPIDURAL TRAY |
||||
BASELINE CATALOGUE NUMBER |
555861 |
||||
BASELINE MODEL NUMBER |
CESK |
||||
BASELINE DEVICE FAMILY |
CONTINUOUS EPIDURAL TRAYS |
||||
BASELINE DEVICE 510(K) NUMBER |
K813186 |
||||
BASELINE SHELF LIFE INFORMATION |
YES |
||||
IS BASELINE PMA NUMBER PROVIDED?</< TH> |
NO |
||||
BASELINE PREAMENDMENT? |
NO |
||||
TRANSITIONAL? |
NO |
||||
510(K) EXEMPT? |
NO |
||||
SHELF LIFE(Months) |
12 |
||||
DATE FIRST MARKETED |
12/03/1981 |
||||
MANUFACTURER (Section F) |
|
||||
MANUFACTURER (Section D) |
|
||||
MANUFACTURER CONTACT |
|
||||
DEVICE EVENT KEY |
237195 |
||||
MDR REPORT KEY |
244827 |
||||
EVENT KEY |
229688 |
||||
REPORT NUMBER |
2523676-1999-00027 |
||||
DEVICE SEQUENCE NUMBER |
1 |
||||
PRODUCT CODE |
CAZ |
||||
REPORT SOURCE |
MANUFACTURER |
||||
SOURCE TYPE |
USER FACILITY |
||||
REMEDIAL ACTION |
OTHER |
||||
EVENT TYPE |
INJURY |
||||
TYPE OF REPORT |
INITIAL |
||||
REPORT DATE |
09/27/1999,10/05/1999 |
||||
1 DEVICE WAS INVOLVED IN THE EVENT |
|
||||
1 PATIENT WAS INVOLVED IN THE EVENT |
|
||||
DATE FDA RECEIVED |
10/13/1999 |
||||
IS THIS AN ADVERSE EVENT REPORT? |
YES |
||||
IS THIS A PRODUCT PROBLEM REPORT? |
NO |
||||
DEVICE OPERATOR |
HEALTH PROFESSIONAL |
||||
DEVICE MODEL NUMBER |
CESK |
||||
DEVICE CATALOGUE NUMBER |
555825 |
||||
WAS DEVICE AVAILABLE FOR EVALUATION? |
NO |
||||
IS THE REPORTER A HEALTH PROFESSIONAL? |
YES |
||||
WAS THE REPORT SENT TO FDA? |
NO |
||||
DISTRIBUTOR FACILITY AWARE DATE |
09/14/1999 |
||||
DEVICE AGE |
UNKNOWN |
||||
EVENT LOCATION |
HOSPITAL |
||||
DATE MANUFACTURER RECEIVED |
09/14/1999 |
||||
WAS DEVICE EVALUATED BY MANUFACTURER? |
DEVICE NOT RETURNED TO MANUFACTURER |
||||
IS THE DEVICE SINGLE USE? |
YES |
||||
TYPE OF DEVICE USAGE |
UNKNOWN |
||||
PATIENT OUTCOME |
REQUIRED INTERVENTION |
ADVERSE EVENT OR PRODUCT PROBLEM DESCRIPTION |
REPORT DATE: 09/27/1999 MDR TEXT KEY: 825537 Patient Sequence Number: 1 |
DURING KNEE ARTHROSCOPY, THE PHYSICIAN PLACED AN EPIDURAL CATHETER IN THE PT. DUE TO THE PT'S SIZE, THE DR ENCOUNTERED SOME DIFFICULTIES IN FINDING THE EPIDURAL SPACE, BUT THE PROCEDURE WAS OTHERWISE UNEVENTFUL. SEVERAL DAYS LATER, THE PT DEVELOPED AN EPIDURAL ABSCESS WHICH REQUIRED SURGICAL DEBRIDEMENT. THE PT WAS GIVEN LONGTERM ANTIBIOTICS AND RELEASED. THE PT SUFFERED NO ADVERSE EFFECTS AS A RESULT OF THIS OCCURRENCE. |
|
ADDITIONAL MANUFACTURER NARRATIVE |
REPORT DATE: 09/27/1999 MDR TEXT KEY: 825540 |
NO CONCLUSION CAN BE DRAWN SINCE THE DEVICE WAS NOT RETURNED FOR EVALUATION. TO DATE, THE MFR HAS RECEIVED NO OTHER REPORTS OF THIS NATURE FOR THIS PRODUCT. THERE IS NO EVIDENCE TO SUGGEST THAT THIS PRODUCT CAUSED OR CONTRIBUTED TO THIS EVENT. NO FURTHER INFO IS AVAILABLE ON THE PT'S STATUS. |
56.
BRAND NAME |
PERIFIX |
||||
TYPE OF DEVICE |
PERIFIX CONTINUOUS EPIDURAL CUSTOM TRAY |
||||
BASELINE BRAND NAME |
PERIFIX |
||||
BASELINE GENERIC NAME |
CUSTOM EPIDURAL TRAY |
||||
BASELINE CATALOGUE NUMBER |
555861 |
||||
BASELINE MODEL NUMBER |
CESK |
||||
BASELINE DEVICE FAMILY |
CONTINUOUS EPIDURAL TRAYS |
||||
BASELINE DEVICE 510(K) NUMBER |
K813186 |
||||
BASELINE SHELF LIFE INFORMATION |
YES |
||||
IS BASELINE PMA NUMBER PROVIDED?</< TH> |
NO |
||||
BASELINE PREAMENDMENT? |
NO |
||||
TRANSITIONAL? |
NO |
||||
510(K) EXEMPT? |
NO |
||||
SHELF LIFE(Months) |
12 |
||||
DATE FIRST MARKETED |
12/03/1981 |
||||
MANUFACTURER (Section F) |
|
||||
MANUFACTURER (Section D) |
|
||||
MANUFACTURER (Section G) |
|
||||
MANUFACTURER CONTACT |
|
||||
DEVICE EVENT KEY |
225961 |
||||
MDR REPORT KEY |
233118 |
||||
EVENT KEY |
218752 |
||||
REPORT NUMBER |
2523676-1999-00023 |
||||
DEVICE SEQUENCE NUMBER |
1 |
||||
PRODUCT CODE |
CAZ |
||||
REPORT SOURCE |
MANUFACTURER |
||||
SOURCE TYPE |
USER FACILITY |
||||
REMEDIAL ACTION |
OTHER |
||||
EVENT TYPE |
INJURY |
||||
TYPE OF REPORT |
INITIAL |
||||
REPORT DATE |
07/21/1999 |
||||
1 DEVICE WAS INVOLVED IN THE EVENT |
|
||||
1 PATIENT WAS INVOLVED IN THE EVENT |
|
||||
DATE FDA RECEIVED |
07/23/1999 |
||||
IS THIS AN ADVERSE EVENT REPORT? |
YES |
||||
IS THIS A PRODUCT PROBLEM REPORT? |
NO |
||||
DEVICE OPERATOR |
HEALTH PROFESSIONAL |
||||
DEVICE EXPIRATION DATE |
01/31/2000 |
||||
DEVICE MODEL NUMBER |
CESK |
||||
DEVICE CATALOGUE NUMBER |
555509 |
||||
DEVICE LOT NUMBER |
960270 |
||||
WAS DEVICE AVAILABLE FOR EVALUATION? |
NO |
||||
IS THE REPORTER A HEALTH PROFESSIONAL? |
YES |
||||
WAS THE REPORT SENT TO FDA? |
NO |
||||
DISTRIBUTOR FACILITY AWARE DATE |
06/22/1999 |
||||
DEVICE AGE |
6 MO |
||||
EVENT LOCATION |
HOSPITAL |
||||
DATE MANUFACTURER RECEIVED |
06/25/1999 |
||||
WAS DEVICE EVALUATED BY MANUFACTURER? |
DEVICE NOT RETURNED TO MANUFACTURER |
||||
DATE DEVICE MANUFACTURED |
01/01/1999 |
||||
IS THE DEVICE SINGLE USE? |
YES |
||||
TYPE OF DEVICE USAGE |
INITIAL |
||||
PATIENT OUTCOME |
REQUIRED INTERVENTION |
ADVERSE EVENT OR PRODUCT PROBLEM DESCRIPTION |
REPORT DATE: 07/21/1999 MDR TEXT KEY: 780996 Patient Sequence Number: 1 |
THE DR FELT RESISTANCE WHILE ATTEMPTINTG TO REMOVE THE CATHETER. HE WAS ABLE TO MANIPULATE THE CATHETER SO THAT IT APPEARED TO BE COMING OUT WITH NO PROBLEM. AGAIN, RESISTANCE WAS FELT, AND THE CATHETER FRACTURED. THE CATHETER WAS DISCARDED, AND THE AMOUNT OF THE CATHETER THAT FRACTURED IS UNK --THE FRAGMENT WILL REMAIN IN THE PT. |
|
ADDITIONAL MANUFACTURER NARRATIVE |
REPORT DATE: 07/23/1999 MDR TEXT KEY: 780999 |
THE INFO PROVIDED BY THE USER FACILITY SUGGESTS THAT THE CATHETER HAD BECOME LODGED BETWEEEN TWO RIGID STRUCTURES, AND STRETCHED BEYOND IT'S INTENDED DESIGN CAPABILITIES DURING REMOVAL. NO SPECIFIC CONCLUSION CAN BE DRAWN SINCE THE DEVICE WAS NOT RETURNED FOR EVAL. NO FURTHER INFO IS AVAILABLE ON THE PT'S STATUS. IT SHOULD ALSO BE NOTED THAT THE LABELING ON THE TRAY STATES, "DO NOT WITHDRAW CATHETER THROUGH THE NEEDLE BECAUSE OF POSSIBLE DANGER OF SHEARING." |
57.
BRAND NAME |
PERIFIX |
||||
TYPE OF DEVICE |
PERIFIX CONTINUOUS EPIDURAL TRAY |
||||
MANUFACTURER (Section F) |
|
||||
MANUFACTURER (Section D) |
|
||||
MANUFACTURER (Section G) |
|
||||
DEVICE EVENT KEY |
223116 |
||||
MDR REPORT KEY |
230055 |
||||
EVENT KEY |
215962 |
||||
REPORT NUMBER |
2523676-1999-00022 |
||||
DEVICE SEQUENCE NUMBER |
1 |
||||
PRODUCT CODE |
CAZ |
||||
REPORT SOURCE |
MANUFACTURER |
||||
SOURCE TYPE |
USER FACILITY |
||||
REMEDIAL ACTION |
OTHER |
||||
EVENT TYPE |
INJURY |
||||
TYPE OF REPORT |
INITIAL |
||||
REPORT DATE |
06/21/1999,06/28/1999 |
||||
1 DEVICE WAS INVOLVED IN THE EVENT |
|
||||
1 PATIENT WAS INVOLVED IN THE EVENT |
|
||||
DATE FDA RECEIVED |
07/02/1999 |
||||
IS THIS AN ADVERSE EVENT REPORT? |
NO |
||||
DEVICE OPERATOR |
HEALTH PROFESSIONAL |
||||
DEVICE EXPIRATION DATE |
09/30/2000 |
||||
DEVICE MODEL NUMBER |
CE18TK |
||||
DEVICE CATALOGUE NUMBER |
332220 |
||||
DEVICE LOT NUMBER |
945620 |
||||
WAS DEVICE AVAILABLE FOR EVALUATION? |
NO |
||||
IS THE REPORTER A HEALTH PROFESSIONAL? |
NO |
||||
WAS THE REPORT SENT TO FDA? |
NO |
||||
DISTRIBUTOR FACILITY AWARE DATE |
05/19/1999 |
||||
DEVICE AGE |
6 MO |
||||
EVENT LOCATION |
HOSPITAL |
||||
DATE MANUFACTURER RECEIVED |
06/21/1999 |
||||
WAS DEVICE EVALUATED BY MANUFACTURER? |
DEVICE NOT RETURNED TO MANUFACTURER |
||||
DATE DEVICE MANUFACTURED |
01/01/1999 |
||||
IS THE DEVICE SINGLE USE? |
YES |
||||
TYPE OF DEVICE USAGE |
UNKNOWN |
||||
PATIENT OUTCOME |
REQUIRED INTERVENTION |
ADVERSE EVENT OR PRODUCT PROBLEM DESCRIPTION |
REPORT DATE: 06/21/1999 MDR TEXT KEY: 767565 Patient Sequence Number: 1 |
WHEN DR WITHDREW THE CATHETER, HE NOTICED THE TIP WAS MISSING. |
|
ADDITIONAL MANUFACTURER NARRATIVE |
REPORT DATE: 07/02/1999 MDR TEXT KEY: 767568 |
NO CONCLUSION CAN BE DRAWN SINCE THE DEVICE WAS NOT RETURNED FOR EVAL. A SUBSEQUENT CT SCAN AND X-RAY DID NOT SHOW ANY CATHETER FRAGMENTS REMAINING IN THE PT. THE PT SUFFERED NO ADVERSE EFFECTS AS A RESULT OF THIS OCCURRENCE. IT SHOULD BE NOTED THAT THE LABELING ON THE TRAY STATES: "DO NOT WITHDRAW CATHETER THROUGH NEEDLE BECAUSE OF POSSIBLE DANGER OF SHEARING." |
58.
BRAND NAME |
PERIFIX |
||||
TYPE OF DEVICE |
PERIFIX CONTINUOUS EPIDURAL SETS |
||||
BASELINE BRAND NAME |
PERIFIX |
||||
BASELINE GENERIC NAME |
CONTINUOUS EPIDURAL TRAY |
||||
BASELINE CATALOGUE NUMBER |
332200 |
||||
BASELINE MODEL NUMBER |
CE18T |
||||
BASELINE DEVICE FAMILY |
CONTINUOUS EPIDURAL KITS |
||||
BASELINE DEVICE 510(K) NUMBER |
K840179 |
||||
BASELINE SHELF LIFE INFORMATION |
YES |
||||
IS BASELINE PMA NUMBER PROVIDED?</< TH> |
NO |
||||
BASELINE PREAMENDMENT? |
NO |
||||
TRANSITIONAL? |
NO |
||||
510(K) EXEMPT? |
NO |
||||
SHELF LIFE(Months) |
12 |
||||
DATE FIRST MARKETED |
02/24/1984 |
||||
MANUFACTURER (Section F) |
|
||||
MANUFACTURER (Section D) |
|
||||
MANUFACTURER (Section G) |
|
||||
MANUFACTURER CONTACT |
|
||||
DEVICE EVENT KEY |
213327 |
||||
MDR REPORT KEY |
219966 |
||||
EVENT KEY |
206393 |
||||
REPORT NUMBER |
2523676-1999-00009 |
||||
DEVICE SEQUENCE NUMBER |
1 |
||||
PRODUCT CODE |
CAZ |
||||
REPORT SOURCE |
MANUFACTURER |
||||
SOURCE TYPE |
USER FACILITY |
||||
REMEDIAL ACTION |
OTHER |
||||
EVENT TYPE |
INJURY |
||||
TYPE OF REPORT |
INITIAL |
||||
REPORT DATE |
03/17/1999,04/16/1999 |
||||
1 DEVICE WAS INVOLVED IN THE EVENT |
|
||||
1 PATIENT WAS INVOLVED IN THE EVENT |
|
||||
DATE FDA RECEIVED |
04/20/1999 |
||||
IS THIS AN ADVERSE EVENT REPORT? |
YES |
||||
IS THIS A PRODUCT PROBLEM REPORT? |
NO |
||||
DEVICE OPERATOR |
HEALTH PROFESSIONAL |
||||
DEVICE MODEL NUMBER |
CE18T |
||||
DEVICE CATALOGUE NUMBER |
332200 |
||||
DEVICE LOT NUMBER |
822660 |
||||
WAS DEVICE AVAILABLE FOR EVALUATION? |
YES |
||||
IS THE REPORTER A HEALTH PROFESSIONAL? |
YES |
||||
WAS THE REPORT SENT TO FDA? |
NO |
||||
DISTRIBUTOR FACILITY AWARE DATE |
03/10/1999 |
||||
DEVICE AGE |
UNKNOWN |
||||
EVENT LOCATION |
HOSPITAL |
||||
DATE REPORT TO MANUFACTURER |
03/17/1999 |
||||
DATE MANUFACTURER RECEIVED |
03/23/1999 |
||||
WAS DEVICE EVALUATED BY MANUFACTURER? |
DEVICE NOT RETURNED TO MANUFACTURER |
||||
DATE DEVICE MANUFACTURED |
10/01/1998 |
||||
IS THE DEVICE SINGLE USE? |
YES |
||||
TYPE OF DEVICE USAGE |
UNKNOWN |
||||
PATIENT OUTCOME |
REQUIRED INTERVENTION |
ADDITIONAL MANUFACTURER NARRATIVE |
REPORT DATE: 03/17/1999 MDR TEXT KEY: 729445 |
THE INFO PROVIDED IN THE MEDWATCH REPORT WAS INSUFFICIENT TO DRAW ANY CONCLUSIONS REGARDING THIS EVENT. THE USER FACILITY WAS CONTACTED, BUT CALLS HAVE NOT BEEN RETURNED. THIS REPORT WILL BE RE-OPENED AND A FOLLOW-UP WILL BE FILED IF ADD'L INFO BECOMES AVAILABLE. NO FURTHER INFO IS AVAILABLE ON THE PT'S STATUS. IT SHOULD BE NOTED THAT THE LABELING ON THE TRAY STATES: "DO NOT WITHDRAW CATHETER THROUGH NEEDLE BECAUSE OF POSSIBLE DANGER OF SHEARING." |
|
ADVERSE EVENT OR PRODUCT PROBLEM DESCRIPTION |
REPORT DATE: 03/17/1999 MDR TEXT KEY: 729442 Patient Sequence Number: 1 |
MEDWATCH REPORT RECEIVED FROM THE USER/FACILITY STATES: "ON 3/7/99, A THORACOLUMBER FUSION WAS PERFORMED. INCIDENTAL TO THIS PROCEDURE AN EPIDURAL CATHETER WAS INSERTED. ON 3/10/99 A LUMBAR RE-EXPLORATION WAS PERFORMED TO REMOVE A SECTION OF FRACTURED CATHETER." |
59.
BRAND NAME |
PERIFIX |
||||
TYPE OF DEVICE |
PERIFIX CONTINUOUS EPIDURAL TRAY |
||||
BASELINE BRAND NAME |
PERIFIX |
||||
BASELINE GENERIC NAME |
EPIDURAL CATHETER |
||||
BASELINE CATALOGUE NUMBER |
332221 |
||||
BASELINE MODEL NUMBER |
CE17TK |
||||
BASELINE DEVICE FAMILY |
EPIDURAL CATHETER |
||||
BASELINE DEVICE 510(K) NUMBER |
K840179 |
||||
BASELINE SHELF LIFE INFORMATION |
YES |
||||
IS BASELINE PMA NUMBER PROVIDED?</< TH> |
NO |
||||
BASELINE PREAMENDMENT? |
NO |
||||
TRANSITIONAL? |
NO |
||||
510(K) EXEMPT? |
NO |
||||
SHELF LIFE(Months) |
12 |
||||
DATE FIRST MARKETED |
02/24/1984 |
||||
MANUFACTURER (Section F) |
|
||||
MANUFACTURER (Section D) |
|
||||
MANUFACTURER (Section G) |
|
||||
MANUFACTURER CONTACT |
|
||||
DEVICE EVENT KEY |
198594 |
||||
MDR REPORT KEY |
204474 |
||||
EVENT KEY |
192062 |
||||
REPORT NUMBER |
2523676-1998-00036 |
||||
DEVICE SEQUENCE NUMBER |
1 |
||||
PRODUCT CODE |
CAZ |
||||
REPORT SOURCE |
MANUFACTURER |
||||
SOURCE TYPE |
USER FACILITY |
||||
REMEDIAL ACTION |
OTHER |
||||
EVENT TYPE |
INJURY |
||||
TYPE OF REPORT |
INITIAL |
||||
REPORT DATE |
12/28/1998 |
||||
1 DEVICE WAS INVOLVED IN THE EVENT |
|
||||
1 PATIENT WAS INVOLVED IN THE EVENT |
|
||||
DATE FDA RECEIVED |
12/30/1998 |
||||
IS THIS AN ADVERSE EVENT REPORT? |
YES |
||||
IS THIS A PRODUCT PROBLEM REPORT? |
NO |
||||
DEVICE OPERATOR |
HEALTH PROFESSIONAL |
||||
DEVICE MODEL NUMBER |
CE17TK |
||||
DEVICE CATALOGUE NUMBER |
332221 |
||||
DEVICE LOT NUMBER |
679920 |
||||
WAS DEVICE AVAILABLE FOR EVALUATION? |
YES |
||||
IS THE REPORTER A HEALTH PROFESSIONAL? |
YES |
||||
WAS THE REPORT SENT TO FDA? |
NO |
||||
DISTRIBUTOR FACILITY AWARE DATE |
11/28/1998 |
||||
DEVICE AGE |
NO INFO |
||||
EVENT LOCATION |
HOSPITAL |
||||
DATE MANUFACTURER RECEIVED |
11/30/1998 |
||||
WAS DEVICE EVALUATED BY MANUFACTURER? |
DEVICE NOT RETURNED TO MANUFACTURER |
||||
DATE DEVICE MANUFACTURED |
07/01/1996 |
||||
IS THE DEVICE SINGLE USE? |
YES |
||||
TYPE OF DEVICE USAGE |
INITIAL |
||||
PATIENT OUTCOME |
REQUIRED INTERVENTION |
ADVERSE EVENT OR PRODUCT PROBLEM DESCRIPTION |
REPORT DATE: 12/28/1998 MDR TEXT KEY: 669426 Patient Sequence Number: 1 |
TWO DAYS AFTER EPIDURAL, PT DEVELOPED A CELLUITIS AND ABCESS. UPON DEBRIDMENT BY SURGEON A SMALL METAL SILVER (SHAVING) WAS FOUND. |
|
ADDITIONAL MANUFACTURER NARRATIVE |
REPORT DATE: 12/28/1998 MDR TEXT KEY: 669429 |
THE SAMPLE HAS BEEN REQUESTED FROM THE USER FACILITY, BUT HAS NOT YET BEEN REC'D. A FOLLOW-UP REPORT WILL BE FILED IF THE SAMPLE OR ADDITIONAL INFO BECOMES AVAILABLE. |
60.
BRAND NAME |
PERIFIX |
||||
TYPE OF DEVICE |
PERIFIX CONTINUOUS EPIDUAL TRAY |
||||
BASELINE BRAND NAME |
PERIFIX |
||||
BASELINE GENERIC NAME |
PERIFIX CONTINUOUS EPIDUAL TRAY |
||||
BASELINE CATALOGUE NUMBER |
332221 |
||||
BASELINE MODEL NUMBER |
CEI7TK |
||||
MANUFACTURER (Section F) |
|
||||
MANUFACTURER (Section D) |
|
||||
MANUFACTURER (Section G) |
|
||||
DEVICE EVENT KEY |
194339 |
||||
MDR REPORT KEY |
200053 |
||||
EVENT KEY |
187959 |
||||
REPORT NUMBER |
2523676-1998-00033 |
||||
DEVICE SEQUENCE NUMBER |
1 |
||||
PRODUCT CODE |
CAZ |
||||
REPORT SOURCE |
MANUFACTURER |
||||
SOURCE TYPE |
USER FACILITY |
||||
REMEDIAL ACTION |
OTHER |
||||
EVENT TYPE |
INJURY |
||||
TYPE OF REPORT |
INITIAL |
||||
REPORT DATE |
11/25/1998 |
||||
1 DEVICE WAS INVOLVED IN THE EVENT |
|
||||
1 PATIENT WAS INVOLVED IN THE EVENT |
|
||||
DATE FDA RECEIVED |
11/30/1998 |
||||
IS THIS AN ADVERSE EVENT REPORT? |
YES |
||||
IS THIS A PRODUCT PROBLEM REPORT? |
NO |
||||
DEVICE OPERATOR |
HEALTH PROFESSIONAL |
||||
DEVICE EXPIRATION DATE |
12/01/1999 |
||||
DEVICE MODEL NUMBER |
CEI7TK |
||||
DEVICE CATALOGUE NUMBER |
332221 |
||||
DEVICE LOT NUMBER |
422300 |
||||
WAS DEVICE AVAILABLE FOR EVALUATION? |
YES |
||||
IS THE REPORTER A HEALTH PROFESSIONAL? |
YES |
||||
WAS THE REPORT SENT TO FDA? |
NO |
||||
DISTRIBUTOR FACILITY AWARE DATE |
09/23/1998 |
||||
DEVICE AGE |
1 YR |
||||
EVENT LOCATION |
HOSPITAL |
||||
DATE MANUFACTURER RECEIVED |
09/24/1998 |
||||
WAS DEVICE EVALUATED BY MANUFACTURER? |
YES |
||||
DATE DEVICE MANUFACTURED |
03/01/1998 |
||||
IS THE DEVICE SINGLE USE? |
YES |
||||
TYPE OF DEVICE USAGE |
UNKNOWN |
||||
PATIENT OUTCOME |
REQUIRED INTERVENTION |
ADVERSE EVENT OR PRODUCT PROBLEM DESCRIPTION |
REPORT DATE: 11/25/1998 MDR TEXT KEY: 651960 Patient Sequence Number: 1 |
TIP OF CATHETER NOT FOUND UPON REMOVAL FROM PT. |
|
ADDITIONAL MANUFACTURER NARRATIVE |
REPORT DATE: 11/30/1998 MDR TEXT KEY: 651963 |
THE RETURNED SAMPLE DID NOT EXHIBIT ANY VISIBLE MFG RELATED DEFECTS. THE RETURNED SAMPLE WAS STRETCHED AND ELONGATED. THE APPEARANCE OF THE RETURNED SAMPLE INDICATES THAT THE CATHETER HAD BECOME LODGED BETWEEN TWO RIGID BODY STRUCTURES, AND STRETCHED BEYOND IT'S INTENDED DESIGN CAPABILITES DURING REMOVAL. THIS OCCURRENCE DID NOT APPEAR TO BE THE RESULT OF ANY PRODUCT QUALIY DEFICIENCIES OR PRODUCT MALFUNCTION. NO FURTHER INFO IS AVAILABLE ON THE PT'S STATUS. IT SHOULD ALSO BE NOTED THAT THE LABELING ON THE TRAY STATES, "DO NOT WITHDRAWAL CATHETER THROUGHT THE NEEDLE BECAUSE OF POSSIBLE DANGER OF SHEARING". DISCLAIMER: B. BRAUN MEDICAL INC. IS SUBMITTING THIS REPORT TO THE FDA IN ACCORDANCE WITH THE FEDERAL REGISTER, 21 CFR PART 803 (MEDICAL DEVICE REPORTING) DATED DECEMBER 11, 1995. B. BRAUN MEDICAL INC. DOES NOT INTEND THIS SUBMISSION TO BE USED IN ANY WAY AS AN ADMISSION THAT THE REPORTED INCIDENT ACTUALLY CAUSED OR CONTRIBUTED TO ANY DEATH OR SERIOUS INJURY. THIS INFO HAS NOT BEEN VERIFIED FOR ACCURACY, COMPLETENESS OR ANY CAUSAL RELATIONSHIPS TO DEVICES MFG OR DISTRIBUTED BY B. BRAUN MEDICAL, INC. |
61.
BRAND NAME |
PERIFIX |
||||
TYPE OF DEVICE |
PERIFIX CONTINUOUS EPIDURAL TRAY |
||||
MANUFACTURER (Section F) |
|
||||
MANUFACTURER (Section D) |
|
||||
MANUFACTURER (Section G) |
|
||||
DEVICE EVENT KEY |
190940 |
||||
MDR REPORT KEY |
196532 |
||||
EVENT KEY |
184693 |
||||
REPORT NUMBER |
2523676-1998-00031 |
||||
DEVICE SEQUENCE NUMBER |
1 |
||||
PRODUCT CODE |
CAZ |
||||
REPORT SOURCE |
MANUFACTURER |
||||
SOURCE TYPE |
USER FACILITY |
||||
REMEDIAL ACTION |
OTHER |
||||
EVENT TYPE |
INJURY |
||||
TYPE OF REPORT |
INITIAL |
||||
REPORT DATE |
11/06/1998 |
||||
1 DEVICE WAS INVOLVED IN THE EVENT |
|
||||
1 PATIENT WAS INVOLVED IN THE EVENT |
|
||||
DATE FDA RECEIVED |
11/10/1998 |
||||
IS THIS AN ADVERSE EVENT REPORT? |
YES |
||||
IS THIS A PRODUCT PROBLEM REPORT? |
NO |
||||
DEVICE OPERATOR |
HEALTH PROFESSIONAL |
||||
DEVICE EXPIRATION DATE |
02/01/2001 |
||||
DEVICE MODEL NUMBER |
CE18HK |
||||
DEVICE CATALOGUE NUMBER |
332230 |
||||
DEVICE LOT NUMBER |
485640 |
||||
WAS DEVICE AVAILABLE FOR EVALUATION? |
YES |
||||
IS THE REPORTER A HEALTH PROFESSIONAL? |
YES |
||||
WAS THE REPORT SENT TO FDA? |
NO |
||||
DEVICE AGE |
UNKNOWN |
||||
EVENT LOCATION |
HOSPITAL |
||||
DATE MANUFACTURER RECEIVED |
10/21/1998 |
||||
WAS DEVICE EVALUATED BY MANUFACTURER? |
YES |
||||
DATE DEVICE MANUFACTURED |
02/01/1998 |
||||
IS THE DEVICE SINGLE USE? |
YES |
||||
TYPE OF DEVICE USAGE |
INITIAL |
||||
PATIENT OUTCOME |
REQUIRED INTERVENTION |
ADVERSE EVENT OR PRODUCT PROBLEM DESCRIPTION |
REPORT DATE: 11/06/1998 MDR TEXT KEY: 637877 Patient Sequence Number: 1 |
WHEN CATHETER WAS REMOVED, THE CATHETER FRACTURED AND A SEGMENT REMAINED IN THE PT. |
|
ADDITIONAL MANUFACTURER NARRATIVE |
REPORT DATE: 11/06/1998 MDR TEXT KEY: 637880 |
THE RETURNED SAMPLE DID NOT EXHIBIT ANY VISIBLE MFG RELATED DEFECTS. THE RETURNED SAMPLE WAS STRETCHED AND ELONGATED. THE INFO PROVIDED IN THE REPORT, AND THE APPEARANCE OF THE RETURNED SAMPLE, INDICATE THAT THE CATHETER HAD BECOME LODGED BETWEEN TWO RIGID BODY STRUCTURES, AND STRETCHED BEYOND IT'S INTENDED DESIGN CAPABILITIES DURING REMOVAL. THIS OCCURRENCE DID NOT APPEAR TO BE THE RESULT OF ANY PRODUCT QUALITY DEFICIENCIES OR PRODUCT MALFUNCTION. NO FURTHER INFO IS AVAILABLE ON THE PT'S STATUS. IT SHOULD ALSO BE NOTED THAT THE LABELING ON THE TRAY STATES, "DO NOT WITHDRAWAL CATHETER THROUGH THE NEEDLE BECAUSE OF POSSIBLE DANGER OF SHEARING." DISCLAIMER: B. BRAUN MEDICAL INC. IS SUBMITTING THIS REPORT TO THE FDA IN ACCORDANCE WITH THE FEDERAL REGISTER, 21 CFR PART 803 (MEDICAL DEVICE REPORTING) DATED 12/11/95. B. BRAUN MEDICAL INC. DOES NOT INTEND THIS SUBMISSION TO BE USED IN ANY WAY AS AN ADMISSION THAT THE REPORTED INCIDENT ACTUALLY CAUSED OR CONTRIBUTED TO ANY DEATH OR SERIOUS INJURY. THIS INFO HAS NOT BEEN VERIFIED FOR ACCURACY, COMPLETENESS OR ANY CASUAL RELATIONSHIP TO DEVICES MFG OR DISTRIBUTED BY B. BRAUN MEDICAL, INC. |
62.
BRAND NAME |
PERIFIX |
||||
TYPE OF DEVICE |
PERIFIX CONTINUOUS EPIDURAL TRAY |
||||
MANUFACTURER (Section F) |
|
||||
MANUFACTURER (Section D) |
|
||||
MANUFACTURER (Section G) |
|
||||
DEVICE EVENT KEY |
189821 |
||||
MDR REPORT KEY |
195375 |
||||
EVENT KEY |
183604 |
||||
REPORT NUMBER |
2523676-1998-00028 |
||||
DEVICE SEQUENCE NUMBER |
1 |
||||
PRODUCT CODE |
CAZ |
||||
REPORT SOURCE |
MANUFACTURER |
||||
SOURCE TYPE |
USER FACILITY |
||||
REMEDIAL ACTION |
OTHER |
||||
EVENT TYPE |
INJURY |
||||
TYPE OF REPORT |
INITIAL |
||||
REPORT DATE |
10/27/1998,10/12/1998 |
||||
1 DEVICE WAS INVOLVED IN THE EVENT |
|
||||
1 PATIENT WAS INVOLVED IN THE EVENT |
|
||||
DATE FDA RECEIVED |
11/02/1998 |
||||
IS THIS AN ADVERSE EVENT REPORT? |
YES |
||||
IS THIS A PRODUCT PROBLEM REPORT? |
NO |
||||
DEVICE OPERATOR |
HEALTH PROFESSIONAL |
||||
DEVICE EXPIRATION DATE |
12/01/1999 |
||||
DEVICE MODEL NUMBER |
CE18TK |
||||
DEVICE CATALOGUE NUMBER |
332220 |
||||
DEVICE LOT NUMBER |
485200 |
||||
WAS DEVICE AVAILABLE FOR EVALUATION? |
YES |
||||
IS THE REPORTER A HEALTH PROFESSIONAL? |
YES |
||||
WAS THE REPORT SENT TO FDA? |
NO |
||||
DEVICE AGE |
UNKNOWN |
||||
EVENT LOCATION |
HOSPITAL |
||||
DATE MANUFACTURER RECEIVED |
06/23/1998 |
||||
WAS DEVICE EVALUATED BY MANUFACTURER? |
YES |
||||
IS THE DEVICE SINGLE USE? |
YES |
||||
TYPE OF DEVICE USAGE |
INITIAL |
||||
PATIENT OUTCOME |
REQUIRED INTERVENTION |
ADVERSE EVENT OR PRODUCT PROBLEM DESCRIPTION |
REPORT DATE: 10/27/1998 MDR TEXT KEY: 633256 Patient Sequence Number: 1 |
DURING TUNNELING, THE DR EXPERIENCED BLOOD RETURN. THE CATHETER BROKE UPON REMOVAL, LEAVING A SMALL AMOUNT IN THE EPIDURAL SPACE. PT WAS INFORMED THAT BIT OF THE CATHETER WAS LEFT IN - SUFFERED NO ADVERSE EFFECTS. |
|
ADDITIONAL MANUFACTURER NARRATIVE |
REPORT DATE: 11/02/1998 MDR TEXT KEY: 633259 |
THE RETURNED SAMPLE DID NOT EXHIBIT ANY VISIBLE MFG RELATED DEFECTS. THE CATHETER EXHIBITED A CLEAN EDGE AT APPROX A 45 DEGREE ANGLE AT THE POINT OF SEPARATION, WITH NO VISIBLE SIGNS OF STRETCHING OR TEARING. THE APPEARANCE OF THE BREAK IN INDICATIVE OF A CATHETER WHICH HAS BEEN PULLED BACK THROUGH THE EPIDURAL NEEDLE, AND SHEARED. THIS OCCURRENCE DID NOT APPEAR TO BE THE RESULT OF ANY PRODUCT QUALITY DEFICIENCIES OR PRODUCT MALFUNCTIONS. IT SHOULD BE NOTED THAT THE LABELING ON THE TRAY STATES, "DO NOT WITHDRAWAL CATHETER THROUGH THE NEEDLE BECAUSE OF POSSIBLE DANGER OF SHEARING". NO FURTHER INFO IS AVAILABLE ON THE PT'S STATUS. DISCLAIMER: B. BRAUN MEDICAL INC. IS SUBMITTING THIS REPORT TO THE FDA IN ACCORDANCE WITH THE FEDERAL REGISTER, 21 CFR PART 803 (MEDICAL DEVICE REPORTING ) DATED DECEMBER 11, 1995. B. BRAUN MEDICAL INC. DOES NOT INTEND THIS SUBMISSION TO BE USED IN ANY WAY AS AN ADMISSION THAT THE REPORTED INCIDENT ACTUALLY CAUSED OR CONTRIBUTED TO ANY DEATH OR SERIOUS INJURY. THIS INFO HAS NOT BEEN VERIFIED FOR ACCURACY. COMPLETENESS OR ANY CASUAL RELATIONSHIPS TO DEVICES MFG OR DISTRIBUTED BY B. BRAUN MEDICAL, INC. |
63.
BRAND NAME |
PERIFIX |
||||
TYPE OF DEVICE |
PERIFIX CONTINUOUS EPIDURAL CUSTOM TRAY |
||||
BASELINE BRAND NAME |
PERIFIX |
||||
BASELINE GENERIC NAME |
CUSTOM EPIDURAL TRAY |
||||
BASELINE CATALOGUE NUMBER |
555861 |
||||
BASELINE MODEL NUMBER |
CESK |
||||
BASELINE DEVICE FAMILY |
CONTINUOUS EPIDURAL TRAYS |
||||
BASELINE DEVICE 510(K) NUMBER |
K813186 |
||||
BASELINE SHELF LIFE INFORMATION |
YES |
||||
IS BASELINE PMA NUMBER PROVIDED?</< TH> |
NO |
||||
BASELINE PREAMENDMENT? |
NO |
||||
TRANSITIONAL? |
NO |
||||
510(K) EXEMPT? |
NO |
||||
SHELF LIFE(Months) |
12 |
||||
DATE FIRST MARKETED |
12/03/1981 |
||||
MANUFACTURER (Section F) |
|
||||
MANUFACTURER (Section D) |
|
||||
MANUFACTURER (Section G) |
|
||||
MANUFACTURER CONTACT |
|
||||
DEVICE EVENT KEY |
184920 |
||||
MDR REPORT KEY |
190289 |
||||
EVENT KEY |
178875 |
||||
REPORT NUMBER |
2523676-1998-00027 |
||||
DEVICE SEQUENCE NUMBER |
1 |
||||
PRODUCT CODE |
CAZ |
||||
REPORT SOURCE |
MANUFACTURER |
||||
SOURCE TYPE |
USER FACILITY |
||||
REMEDIAL ACTION |
OTHER |
||||
EVENT TYPE |
INJURY |
||||
TYPE OF REPORT |
INITIAL |
||||
REPORT DATE |
10/01/1998 |
||||
1 DEVICE WAS INVOLVED IN THE EVENT |
|
||||
1 PATIENT WAS INVOLVED IN THE EVENT |
|
||||
DATE FDA RECEIVED |
10/02/1998 |
||||
IS THIS AN ADVERSE EVENT REPORT? |
YES |
||||
IS THIS A PRODUCT PROBLEM REPORT? |
NO |
||||
DEVICE OPERATOR |
HEALTH PROFESSIONAL |
||||
DEVICE MODEL NUMBER |
CESK |
||||
DEVICE CATALOGUE NUMBER |
555044 |
||||
WAS DEVICE AVAILABLE FOR EVALUATION? |
DEVICE NOT RETURNED TO MANUFACTURER |
||||
IS THE REPORTER A HEALTH PROFESSIONAL? |
YES |
||||
WAS THE REPORT SENT TO FDA? |
NO |
||||
DISTRIBUTOR FACILITY AWARE DATE |
09/01/1998 |
||||
DEVICE AGE |
UNKNOWN |
||||
EVENT LOCATION |
HOSPITAL |
||||
DATE MANUFACTURER RECEIVED |
09/03/1998 |
||||
WAS DEVICE EVALUATED BY MANUFACTURER? |
YES |
||||
IS THE DEVICE SINGLE USE? |
YES |
||||
TYPE OF DEVICE USAGE |
INITIAL |
||||
PATIENT OUTCOME |
REQUIRED INTERVENTION |
ADVERSE EVENT OR PRODUCT PROBLEM DESCRIPTION |
REPORT DATE: 10/01/1998 MDR TEXT KEY: 612990 Patient Sequence Number: 1 |
UPON REMOVAL, THE CATHETER WAS DIFFICULT TO REMOVE. ONCE IT WAS OUT OF PT, THE DR THOUGHT THE BLUE TIP WAS MISSING (BROKEN OFF). CATHETER WAS THEN MEASURED AND IT MEASURED LONGER THAN IT WAS WHEN THE CATHETER WAS UNUSED. |
|
ADDITIONAL MANUFACTURER NARRATIVE |
REPORT DATE: 10/02/1998 MDR TEXT KEY: 612993 |
THE RETURNED SAMPLE DID NOT EXHIBIT ANY VISIBLE MFG RELATED DEFECTS. THE INFO PROVIDED IN THE REPORT, AND THE APPEARANCE OF THE RETURNED SAMPLE, INDICATE THAT THE CATHETER HAD BECOME LODGED BETWEEN TWO RIGID BODY STRUCTURES, AND REMOVED IMPROPERLY, STRETCHING THE CATHETER BEYOND IT'S INTENDED DESIGN CAPABILITIES. THIS OCCURRENCE DID NOT APPEAR TO BE THE RESULT OF ANY PRODUCT QUALITY DEFICIENCIES OR PRODUCT MALFUNCTION. NO FURTHER INFO IS AVAILABLE ON THE PT'S STATUS. IS SHOULD ALSO BE NOTED THAT THE LABELING ON THE TRAY STATES. "DO NOT WITHDRAWAL CATHETER THROUGH THE NEEDLE BECAUSE OF POSSIBLE DANGER OF SHEARING". DISCLAIMER: B. BRAUN MEDICAL INC. IS SUBMITTING THIS REPORT TO THE FDA IN ACCORDANCE WITH THE FEDERAL REGISTER, 21 CFR PART 803 (MEDICAL DEVICE REPORTING ) DATED 12/11/1995, B. BRAUN MEDICAL INC. DOES NOT INTEND THIS SUBMISSION TO BE USED IN ANY WAY AS AN ADMISSION THAT THE REPORTED INCIDENT ACTUALLY CAUSED OR CONTRIBUTED TO ANY DEATH OR SERIOUS INJURY. THIS INFO HAS NOT BEEN VERIFIED FOR ACCURACY. COMPLETENESS OR ANY CASUAL RELATIONSHIPS TO DEVICES MFG OR DISTRIBUTED BY B. BRAUN MEDICAL INC. |
64.
BRAND NAME |
PERIFIX |
||||
TYPE OF DEVICE |
PERIFIX CONTINUOUS EPIDURAL TRAY |
||||
BASELINE BRAND NAME |
NA |
||||
BASELINE GENERIC NAME |
CONTINUOUS EPIDURAL KIT |
||||
BASELINE CATALOGUE NUMBER |
551523 |
||||
BASELINE MODEL NUMBER |
CESK |
||||
BASELINE DEVICE FAMILY |
CONTINUOUS EPIDURAL KIT |
||||
BASELINE DEVICE 510(K) NUMBER |
K840179 |
||||
BASELINE SHELF LIFE INFORMATION |
YES |
||||
IS BASELINE PMA NUMBER PROVIDED?</< TH> |
NO |
||||
BASELINE PREAMENDMENT? |
NO |
||||
TRANSITIONAL? |
NO |
||||
510(K) EXEMPT? |
NO |
||||
SHELF LIFE(Months) |
12 |
||||
DATE FIRST MARKETED |
02/24/1984 |
||||
MANUFACTURER (Section F) |
|
||||
MANUFACTURER (Section D) |
|
||||
MANUFACTURER (Section G) |
|
||||
MANUFACTURER CONTACT |
|
||||
DEVICE EVENT KEY |
183928 |
||||
MDR REPORT KEY |
189262 |
||||
EVENT KEY |
177901 |
||||
REPORT NUMBER |
2523676-1998-00024 |
||||
DEVICE SEQUENCE NUMBER |
1 |
||||
PRODUCT CODE |
CAZ |
||||
REPORT SOURCE |
MANUFACTURER |
||||
SOURCE TYPE |
USER FACILITY |
||||
REMEDIAL ACTION |
OTHER |
||||
EVENT TYPE |
INJURY |
||||
TYPE OF REPORT |
INITIAL |
||||
REPORT DATE |
09/21/1998 |
||||
1 DEVICE WAS INVOLVED IN THE EVENT |
|
||||
1 PATIENT WAS INVOLVED IN THE EVENT |
|
||||
DATE FDA RECEIVED |
09/24/1998 |
||||
IS THIS AN ADVERSE EVENT REPORT? |
YES |
||||
IS THIS A PRODUCT PROBLEM REPORT? |
NO |
||||
DEVICE OPERATOR |
HEALTH PROFESSIONAL |
||||
DEVICE MODEL NUMBER |
CE18TK |
||||
DEVICE CATALOGUE NUMBER |
332220 |
||||
DEVICE LOT NUMBER |
485370-POSSIBLE |
||||
WAS DEVICE AVAILABLE FOR EVALUATION? |
NO |
||||
IS THE REPORTER A HEALTH PROFESSIONAL? |
NO |
||||
WAS THE REPORT SENT TO FDA? |
NO |
||||
DISTRIBUTOR FACILITY AWARE DATE |
09/03/1998 |
||||
DEVICE AGE |
UNKNOWN |
||||
EVENT LOCATION |
HOSPITAL |
||||
DATE MANUFACTURER RECEIVED |
09/08/1998 |
||||
WAS DEVICE EVALUATED BY MANUFACTURER? |
DEVICE NOT RETURNED TO MANUFACTURER |
||||
IS THE DEVICE SINGLE USE? |
YES |
||||
TYPE OF DEVICE USAGE |
INITIAL |
||||
PATIENT OUTCOME |
REQUIRED INTERVENTION |
ADVERSE EVENT OR PRODUCT PROBLEM DESCRIPTION |
REPORT DATE: 09/21/1998 MDR TEXT KEY: 608947 Patient Sequence Number: 1 |
ON 9/3/98 AN EPIDURAL CATHETER WAS PLACED IN AN 81-YEAR OLD FEMALE PT DURING A FOUR-HOUR SURGICAL PROCEDURE. APPROX 1.5 HRS POST-OP, THE CATHETER WAS REMOVED. THE NURSE EXPERIENCED DIFFICULTY REMOVING THE CATHETER. THE CATHETER TIP APPEARED STRETCHED UPON REMOVAL AND APPROX 2-5 MM APPEARED TO BE MISSING. THE PT HAS A RARE DEGENERATIVE DISEASE. CATHETER FRAGMENT WAS OBSERVED IN X-RAY AND REMAINS IN THE PT. |
|
ADDITIONAL MANUFACTURER NARRATIVE |
REPORT DATE: 09/24/1998 MDR TEXT KEY: 608950 |
DUE TO THE LACK OF A RETURNED SAMPLE, A POSITIVE CONCLUSION CANNOT BE DRAWN. THE INFO SUPPLIED BY THE FACILITY SUGGESTS THAT THE CATHETER HAD BECOME PINCHED BETWEEN RIGID BODY STRUCTURES, AND REMOVED WITH SUFFICIENT FORCE TO CAUSE THE CATHETER TO BREAK. IT SHOULD ALSO BE NOTED THAT THE LABELING ON THE TRAY STATES. "DO NOT WITHDRAWAL CATHETER THROUGH THE NEEDLE BECAUSE OF POSSIBLE DANGER OF SHEARING." B. BRAUN MEDICAL INC. IS SUBMITTING THIS REPORT TO THE FDA IN ACCORDANCE WITH THE FEDERAL REGISTER, 21 CFR PART 803, (MEDICAL DEVICE REPORTING) DATED DECEMBER 11, 1995. B. BRAUN MEDICAL INC. DOES NOT INTEND THIS SUBMISSION TO BE USED IN ANY WAY AS AN ADMISSION THAT THE REPORTED INCIDENT ACTUALLY CAUSED OR CONTRIBUTED TO ANY DEATH OR SERIOUS INJURY. THIS INFORMATION HAS NOT BEEN VERIFIED FOR ACCURACY, COMPLETENESS, OR ANY CASUAL RELATIONSHIPS TO DEVICES MANUFACTURED OR DISTRIBUTED BY B. BRAUN MEDICAL, INC. |
65.
BRAND NAME |
PERIFIX |
||||
TYPE OF DEVICE |
PERIFIX BASIC CONTINUOUS EPIDURAL TRAY |
||||
BASELINE BRAND NAME |
PERIFIX |
||||
BASELINE GENERIC NAME |
CE TRAY |
||||
BASELINE CATALOGUE NUMBER |
332222 |
||||
BASELINE MODEL NUMBER |
CE18TB |
||||
MANUFACTURER (Section F) |
|
||||
MANUFACTURER (Section D) |
|
||||
MANUFACTURER (Section G) |
|
||||
DEVICE EVENT KEY |
167489 |
||||
MDR REPORT KEY |
172238 |
||||
EVENT KEY |
161862 |
||||
REPORT NUMBER |
2523676-1998-00019 |
||||
DEVICE SEQUENCE NUMBER |
1 |
||||
PRODUCT CODE |
CAZ |
||||
REPORT SOURCE |
MANUFACTURER |
||||
SOURCE TYPE |
USER FACILITY |
||||
REMEDIAL ACTION |
OTHER |
||||
EVENT TYPE |
INJURY |
||||
TYPE OF REPORT |
INITIAL |
||||
REPORT DATE |
06/10/1998 |
||||
1 DEVICE WAS INVOLVED IN THE EVENT |
|
||||
1 PATIENT WAS INVOLVED IN THE EVENT |
|
||||
DATE FDA RECEIVED |
06/12/1998 |
||||
IS THIS AN ADVERSE EVENT REPORT? |
YES |
||||
IS THIS A PRODUCT PROBLEM REPORT? |
NO |
||||
DEVICE OPERATOR |
HEALTH PROFESSIONAL |
||||
DEVICE MODEL NUMBER |
CE18TB |
||||
DEVICE CATALOGUE NUMBER |
332222 |
||||
DEVICE LOT NUMBER |
435780 |
||||
WAS DEVICE AVAILABLE FOR EVALUATION? |
NO |
||||
IS THE REPORTER A HEALTH PROFESSIONAL? |
NO |
||||
WAS THE REPORT SENT TO FDA? |
NO |
||||
DEVICE AGE |
UNKNOWN |
||||
EVENT LOCATION |
HOSPITAL |
||||
DATE MANUFACTURER RECEIVED |
06/03/1998 |
||||
WAS DEVICE EVALUATED BY MANUFACTURER? |
DEVICE NOT RETURNED TO MANUFACTURER |
||||
DATE DEVICE MANUFACTURED |
03/01/1998 |
||||
IS THE DEVICE SINGLE USE? |
YES |
||||
TYPE OF DEVICE USAGE |
UNKNOWN |
||||
PATIENT OUTCOME |
REQUIRED INTERVENTION |
ADVERSE EVENT OR PRODUCT PROBLEM DESCRIPTION |
REPORT DATE: 06/10/1998 MDR TEXT KEY: 542209 Patient Sequence Number: 1 |
UPON REMOVAL OF EPIDURAL CATHETER FOLLOWING SURGERY, IT WAS NOTED BY THE ANESTHESIOLOGIST THAT THE CATHETER WAS SHORTER THAN A SIMILAR UNUSED CATHETER: 2 INCHES WERE NOTED TO BE MISSING AT THE DISTAL END. PT WAS RETURNED TO SURGERY FOR THE REMOVAL OF THE CATHETER FRAGMENT. NO SAMPLE TO BE RETURNED. |
|
ADDITIONAL MANUFACTURER NARRATIVE |
REPORT DATE: 06/10/1998 MDR TEXT KEY: 542212 |
NO CONCLUSION CAN BE DRAWN SINCE THE DEVICE WAS NOT RETURNED FOR EVALUATION. NO FURTHER INFO IS AVAILABLE ON THE PT'S STATUS. IT SHOULD BE NOTED THAT THE LABELING ON THE TRAY STATES, "DO NOT WITHDRAW CATHETER THROUGH THE NEEDLE BECAUSE OF POSSIBLE DANGER OF SHEARING". B. BRAUN MEDICAL INC. IS SUBMITTING THIS REPORT TO THE FDA IN ACCORDANCE WITH THE FEDERAL REGISTER, 21 CFR PART 803 (MEDICAL DEVICE REPORTING) DATED 12/11/1995. B. BRAUN MEDICAL INC. DOES NOT INTEND THIS SUBMISSION TO BE USED IN ANY WAY AS AN ADMISSION THAT THE REPORTED INCIDENT ACTUALLY CAUSED OR CONTRIBUTED TO ANY DEATH OR SERIOUS INJURY. THIS INFO HAS NOT BEEN VERIFIED FOR ACCURACY, COMPLETENESS OR ANY CASUAL RELATIONSHIP TO DEVICES MFG OR DISTRIBUTED BY B. BRAUN MEDICAL, INC. |
66.
BRAND NAME |
PERIFIX |
|||
TYPE OF DEVICE |
PERIFIX CONTINUOUS EPIDURAL TRAY |
|||
BASELINE BRAND NAME |
PERIFIX |
|||
BASELINE GENERIC NAME |
PERIFIX CONTINUOUS EPIDURAL TRAY |
|||
BASELINE CATALOGUE NUMBER |
332202 |
|||
BASELINE MODEL NUMBER |
CE-17T |
|||
MANUFACTURER (Section D) |
|
|||
DEVICE EVENT KEY |
163808 |
|||
MDR REPORT KEY |
168373 |
|||
EVENT KEY |
158222 |
|||
REPORT NUMBER |
168373 |
|||
DEVICE SEQUENCE NUMBER |
1 |
|||
PRODUCT CODE |
CAZ |
|||
REPORT SOURCE |
USER FACILITY |
|||
TYPE OF REPORT |
INITIAL |
|||
REPORT DATE |
04/20/1998 |
|||
1 DEVICE WAS INVOLVED IN THE EVENT |
|
|||
1 PATIENT WAS INVOLVED IN THE EVENT |
|
|||
DATE FDA RECEIVED |
05/19/1998 |
|||
IS THIS AN ADVERSE EVENT REPORT? |
YES |
|||
IS THIS A PRODUCT PROBLEM REPORT? |
NO |
|||
DEVICE OPERATOR |
HEALTH PROFESSIONAL |
|||
DEVICE MODEL NUMBER |
CE-17T |
|||
DEVICE CATALOGUE NUMBER |
332202 |
|||
WAS DEVICE AVAILABLE FOR EVALUATION? |
NO |
|||
IS THE REPORTER A HEALTH PROFESSIONAL? |
YES |
|||
WAS THE REPORT SENT TO FDA? |
NO |
|||
DISTRIBUTOR FACILITY AWARE DATE |
04/15/1998 |
|||
DEVICE AGE |
UNKNOWN |
|||
EVENT LOCATION |
HOSPITAL |
|||
PATIENT OUTCOME |
REQUIRED INTERVENTION |
ADVERSE EVENT OR PRODUCT PROBLEM DESCRIPTION |
REPORT DATE: 04/20/1998 MDR TEXT KEY: 527266 Patient Sequence Number: 1 |
ORIGINAL MEDWATCH FROM UF STATES: "PT HAS INFRACLAVICULA CATHETER IN PLACE. UPON REMOVAL, TIP OF CATHETER WAS NOT PRESENT." PT REQUESTED TO NOT HAVE SURGICALLY REMOVED, BUT TO LEAVE." |
67.
BRAND NAME |
PERIFIX |
||||
TYPE OF DEVICE |
PERIFIX CONTINUOUS EPIDURAL TRAY |
||||
BASELINE BRAND NAME |
PERIFIX |
||||
BASELINE GENERIC NAME |
CONTINUOUS EPIDURAL KIT |
||||
BASELINE CATALOGUE NUMBER |
332221 |
||||
BASELINE MODEL NUMBER |
CE17TK |
||||
BASELINE DEVICE FAMILY |
CONTINUOUS EPIDURAL KITS |
||||
BASELINE DEVICE 510(K) NUMBER |
K840179 |
||||
BASELINE SHELF LIFE INFORMATION |
YES |
||||
IS BASELINE PMA NUMBER PROVIDED?</< TH> |
NO |
||||
BASELINE PREAMENDMENT? |
NO |
||||
TRANSITIONAL? |
NO |
||||
510(K) EXEMPT? |
NO |
||||
SHELF LIFE(Months) |
12 |
||||
MANUFACTURER (Section F) |
|
||||
MANUFACTURER (Section D) |
|
||||
MANUFACTURER (Section G) |
|
||||
MANUFACTURER CONTACT |
|
||||
DEVICE EVENT KEY |
149517 |
||||
MDR REPORT KEY |
162024 |
||||
EVENT KEY |
144126 |
||||
REPORT NUMBER |
2523676-1998-00009 |
||||
DEVICE SEQUENCE NUMBER |
1 |
||||
PRODUCT CODE |
CAZ |
||||
REPORT SOURCE |
MANUFACTURER |
||||
SOURCE TYPE |
USER FACILITY |
||||
REMEDIAL ACTION |
OTHER |
||||
EVENT TYPE |
INJURY |
||||
TYPE OF REPORT |
INITIAL |
||||
REPORT DATE |
02/17/1998 |
||||
1 DEVICE WAS INVOLVED IN THE EVENT |
|
||||
1 PATIENT WAS INVOLVED IN THE EVENT |
|
||||
DATE FDA RECEIVED |
04/09/1998 |
||||
IS THIS AN ADVERSE EVENT REPORT? |
YES |
||||
IS THIS A PRODUCT PROBLEM REPORT? |
NO |
||||
DEVICE OPERATOR |
HEALTH PROFESSIONAL |
||||
DEVICE MODEL NUMBER |
CE17TK |
||||
DEVICE CATALOGUE NUMBER |
332221 |
||||
WAS DEVICE AVAILABLE FOR EVALUATION? |
YES |
||||
IS THE REPORTER A HEALTH PROFESSIONAL? |
YES |
||||
WAS THE REPORT SENT TO FDA? |
YES |
||||
DEVICE AGE |
UNKNOWN |
||||
EVENT LOCATION |
HOSPITAL |
||||
DATE MANUFACTURER RECEIVED |
03/12/1998 |
||||
WAS DEVICE EVALUATED BY MANUFACTURER? |
YES |
||||
IS THE DEVICE SINGLE USE? |
YES |
||||
TYPE OF DEVICE USAGE |
INITIAL |
||||
PATIENT OUTCOME |
REQUIRED INTERVENTION |
ADVERSE EVENT OR PRODUCT PROBLEM DESCRIPTION |
REPORT DATE: 02/17/1998 MDR TEXT KEY: 502101 Patient Sequence Number: 1 |
MEDWATCH REPORT FROM UF STATES: "PT WAS POST-UP WITH AN EPIDURAL FOR PAIN CONTROL. AS PAIN WAS INCREASING, CATHETER WAS EXAMINED AND FOUND TO HAVE SHEARED AT MID-BACK. PT WAS COAGULOPATHIC, SO THE CATHETER HALF STILL (REMAINING) IN THE EPIDURAL SPACE WAS NOT REMOVED UNTIL COAGS (ABR) WERE NORMAL." |
|
ADDITIONAL MANUFACTURER NARRATIVE |
REPORT DATE: 04/09/1998 MDR TEXT KEY: 502104 |
THE RETURNED SAMPLE DID NOT EXHIBIT ANY VISIBLE MFG RELATED DEFECTS. THE SEGMENT EXHIBITED A CLEAN, NON-JAGGED EDGE, WITH NO DISCERNABLE STRETCHING OR REDUCTION IN DIAMETER. THE PROVIDED INFO (THE CATHETER WAS IN THE PT FOR MORE THAN TWENTY FOUR HOURS), AND THE APPEARANCE OF THE BREAK SUGGESTS THAT THE CATHETER CAME IN CONTACT WITH AN UNK SHARP SURFACE WHILE IN THE PT, AND WAS NOT RELATED TO THE MFG PROCESS. NO FURTHER INFO IS AVAILABLE ON THE PT'S STATUS. IT SHOULD BE NOTED THAT THE LABELING ON THE TRAY STATES, "DO NOT WITHDRAWAL CATHETER THROUGH THE NEEDLE BECAUSE OF POSSIBLE DANGER OF SHEARING." B. BRAUN MEDICAL, INC. IS SUBMITTING THIS REPORT TO THE FDA IN ACCORDANCE WITH THE FEDERAL REGISTER, 21 CFR PART 803 (MEDICAL DEVICE REPORTING) DATED DECEMBER 11, 1995. B. BRAUN MEDICAL INC. DOES NOT INTEND THIS SUBMISSION TO BE USED IN ANY WAY AS AN ADMISSION THAT THE REPORTED INCIDENT ACTUALLY CAUSED OR CONTRIBUTED TO ANY DEATH OR SERIOUS INJURY. THIS INFORMATION HAS NOT BEEN VERIFIED FOR ACCURACY COMPLETENESS OR ANY CASUAL RELATIONSHIP TO DEVICES MANUFACTURED OR DISTRIBUTED BY B. BRAUN MEDICAL, INC. |
68.
BRAND NAME |
PERIFIX |
|||
TYPE OF DEVICE |
PERIFIX CONTINUOUS EPIDURAL CUSTOM TRAY |
|||
BASELINE BRAND NAME |
PERIFIX |
|||
BASELINE GENERIC NAME |
CUSTOM EPIDURAL KIT |
|||
BASELINE CATALOGUE NUMBER |
555079 |
|||
BASELINE MODEL NUMBER |
CESK |
|||
BASELINE DEVICE FAMILY |
CONTINUOUS EPIDURAL KITS |
|||
BASELINE DEVICE 510(K) NUMBER |
K840179 |
|||
BASELINE SHELF LIFE INFORMATION |
YES |
|||
IS BASELINE PMA NUMBER PROVIDED?</< TH> |
NO |
|||
BASELINE PREAMENDMENT? |
NO |
|||
TRANSITIONAL? |
NO |
|||
510(K) EXEMPT? |
NO |
|||
SHELF LIFE(Months) |
12 |
|||
DATE FIRST MARKETED |
02/24/1984 |
|||
MANUFACTURER (Section D) |
|
|||
DEVICE EVENT KEY |
156793 |
|||
MDR REPORT KEY |
161010 |
|||
EVENT KEY |
151323 |
|||
REPORT NUMBER |
161010 |
|||
DEVICE SEQUENCE NUMBER |
1 |
|||
PRODUCT CODE |
CAZ |
|||
REPORT SOURCE |
USER FACILITY |
|||
TYPE OF REPORT |
INITIAL |
|||
REPORT DATE |
03/26/1998 |
|||
1 DEVICE WAS INVOLVED IN THE EVENT |
|
|||
1 PATIENT WAS INVOLVED IN THE EVENT |
|
|||
DATE FDA RECEIVED |
04/03/1998 |
|||
IS THIS AN ADVERSE EVENT REPORT? |
YES |
|||
IS THIS A PRODUCT PROBLEM REPORT? |
NO |
|||
DEVICE OPERATOR |
HEALTH PROFESSIONAL |
|||
DEVICE EXPIRATION DATE |
04/01/1999 |
|||
DEVICE MODEL NUMBER |
CESK |
|||
DEVICE CATALOGUE NUMBER |
555100 |
|||
DEVICE LOT NUMBER |
354730 |
|||
WAS DEVICE AVAILABLE FOR EVALUATION? |
NO ANSWER PROVIDED |
|||
IS THE REPORTER A HEALTH PROFESSIONAL? |
YES |
|||
WAS THE REPORT SENT TO FDA? |
NO |
|||
DISTRIBUTOR FACILITY AWARE DATE |
03/17/1998 |
|||
DEVICE AGE |
UNKNOWN |
|||
EVENT LOCATION |
HOSPITAL |
|||
PATIENT OUTCOME |
REQUIRED INTERVENTION |
ADVERSE EVENT OR PRODUCT PROBLEM DESCRIPTION |
REPORT DATE: 03/26/1998 MDR TEXT KEY: 497736 Patient Sequence Number: 1 |
MEDWATCH RECEIVED FROM USER FACILITY STATES: "CATHETER BROKE UPON REMOVAL. PT WITH RETAINED FRAGMENT. |
69.
BRAND NAME |
PERIFIX |
||||
TYPE OF DEVICE |
PERIFIX CONTINUOUS EPIDURAL CUSTOM TRAY |
||||
BASELINE BRAND NAME |
PERIFIX |
||||
BASELINE GENERIC NAME |
CUSTOM EPIDURAL KIT |
||||
BASELINE CATALOGUE NUMBER |
555079 |
||||
BASELINE MODEL NUMBER |
CESK |
||||
BASELINE DEVICE FAMILY |
CONTINUOUS EPIDURAL KITS |
||||
BASELINE DEVICE 510(K) NUMBER |
K840179 |
||||
BASELINE SHELF LIFE INFORMATION |
YES |
||||
IS BASELINE PMA NUMBER PROVIDED?</< TH> |
NO |
||||
BASELINE PREAMENDMENT? |
NO |
||||
TRANSITIONAL? |
NO |
||||
510(K) EXEMPT? |
NO |
||||
SHELF LIFE(Months) |
12 |
||||
DATE FIRST MARKETED |
02/24/1984 |
||||
MANUFACTURER (Section F) |
|
||||
MANUFACTURER (Section D) |
|
||||
MANUFACTURER (Section G) |
|
||||
MANUFACTURER CONTACT |
|
||||
DEVICE EVENT KEY |
156886 |
||||
MDR REPORT KEY |
161112 |
||||
EVENT KEY |
151415 |
||||
REPORT NUMBER |
2523676-1998-00007 |
||||
DEVICE SEQUENCE NUMBER |
1 |
||||
PRODUCT CODE |
CAZ |
||||
REPORT SOURCE |
MANUFACTURER |
||||
SOURCE TYPE |
USER FACILITY |
||||
REMEDIAL ACTION |
OTHER |
||||
EVENT TYPE |
INJURY |
||||
TYPE OF REPORT |
INITIAL |
||||
REPORT DATE |
04/02/1998 |
||||
1 DEVICE WAS INVOLVED IN THE EVENT |
|
||||
1 PATIENT WAS INVOLVED IN THE EVENT |
|
||||
DATE FDA RECEIVED |
04/03/1998 |
||||
IS THIS AN ADVERSE EVENT REPORT? |
YES |
||||
IS THIS A PRODUCT PROBLEM REPORT? |
NO |
||||
DEVICE OPERATOR |
HEALTH PROFESSIONAL |
||||
DEVICE MODEL NUMBER |
CESK |
||||
DEVICE CATALOGUE NUMBER |
555067 |
||||
DEVICE LOT NUMBER |
070450 |
||||
WAS DEVICE AVAILABLE FOR EVALUATION? |
YES |
||||
IS THE REPORTER A HEALTH PROFESSIONAL? |
NO |
||||
WAS THE REPORT SENT TO FDA? |
NO |
||||
DEVICE AGE |
UNKNOWN |
||||
EVENT LOCATION |
HOSPITAL |
||||
DATE MANUFACTURER RECEIVED |
03/04/1998 |
||||
WAS DEVICE EVALUATED BY MANUFACTURER? |
DEVICE NOT RETURNED TO MANUFACTURER |
||||
DATE DEVICE MANUFACTURED |
05/01/1997 |
||||
IS THE DEVICE SINGLE USE? |
YES |
||||
TYPE OF DEVICE USAGE |
UNKNOWN |
||||
PATIENT OUTCOME |
REQUIRED INTERVENTION |
ADVERSE EVENT OR PRODUCT PROBLEM DESCRIPTION |
REPORT DATE: 04/02/1998 MDR TEXT KEY: 498074 Patient Sequence Number: 1 |
CATHETER BROKE OFF IN PATIENT'S BACK. |
|
ADDITIONAL MANUFACTURER NARRATIVE |
REPORT DATE: 04/03/1998 MDR TEXT KEY: 498077 |
THE SAMPLE HAS BEEN REQUESTED FROM THE USER FACILITY, BUT HAS NOT YET BEEN RECIEVED, THEREFORE, NO CONCLUSION CAN BE DRAWN. A FOLLOW-UP WILL BE FILED IF MORE INFO BECOMES AVAILABLE. NO FURTHER INFO IS AVAILABLE ON THE PATIENT'S STATUS. IT SHOULD BE NOTED THAT THE LABELING ON THE TRAY STATES, "DO NOT WITHDRAWAL CATHETER THROUGH THE NEEDLE BECAUSE OF POSSIBLE DANGER OF SHEARING". DISCLAIMER: B. BRAUN MEDICAL INC. IS SUBMITTING THIS REPORT TO THE FDA IN ACCORDANCE WITH THE FEDERAL REGISTER, 21 CFR PART 803 (MEDICAL DEVICE REPORTING) DATED DECEMBER 11, 1995. B. BRAUN MEDICAL INC. DOES NOT INTEND THIS SUBMISSION TO BE USED IN ANY WAY AS AN ADMISSION THAT THE REPORTED INCIDENT ACTUALLY CAUSED OR CONTRIBUTED TO ANY DEATH OR SERIOUS INJURY. THIS INFO HAS NOT BEEN VERIFIED FOR ACCURACY, COMPLETENESS OR ANY CASUAL RELATIONSHIPS TO DEVICES MANUFACTURED OR DISTRIBUTED BY B. BRAUN MEDICAL INC. |
70.
BRAND NAME |
PERIFIX |
||||
TYPE OF DEVICE |
PERIFIX CUSTOM EPIDURAL TRAY |
||||
BASELINE BRAND NAME |
PERIFIX |
||||
BASELINE GENERIC NAME |
CUSTOM EPIDURAL KIT |
||||
BASELINE CATALOGUE NUMBER |
555079 |
||||
BASELINE MODEL NUMBER |
CESK |
||||
BASELINE DEVICE FAMILY |
CONTINUOUS EPIDURAL KITS |
||||
BASELINE DEVICE 510(K) NUMBER |
K840179 |
||||
BASELINE SHELF LIFE INFORMATION |
YES |
||||
IS BASELINE PMA NUMBER PROVIDED?</< TH> |
NO |
||||
BASELINE PREAMENDMENT? |
NO |
||||
TRANSITIONAL? |
NO |
||||
510(K) EXEMPT? |
NO |
||||
SHELF LIFE(Months) |
12 |
||||
DATE FIRST MARKETED |
02/24/1984 |
||||
MANUFACTURER (Section F) |
|
||||
MANUFACTURER (Section D) |
|
||||
MANUFACTURER (Section G) |
|
||||
MANUFACTURER CONTACT |
|
||||
DEVICE EVENT KEY |
146575 |
||||
MDR REPORT KEY |
150428 |
||||
EVENT KEY |
141240 |
||||
REPORT NUMBER |
2523676-1998-00004 |
||||
DEVICE SEQUENCE NUMBER |
1 |
||||
PRODUCT CODE |
CAZ |
||||
REPORT SOURCE |
MANUFACTURER |
||||
SOURCE TYPE |
USER FACILITY |
||||
EVENT TYPE |
INJURY |
||||
TYPE OF REPORT |
INITIAL,FOLLOWUP |
||||
REPORT DATE |
02/19/1998 |
||||
1 DEVICE WAS INVOLVED IN THE EVENT |
|
||||
1 PATIENT WAS INVOLVED IN THE EVENT |
|
||||
DATE FDA RECEIVED |
02/20/1998 |
||||
IS THIS AN ADVERSE EVENT REPORT? |
YES |
||||
IS THIS A PRODUCT PROBLEM REPORT? |
NO |
||||
DEVICE OPERATOR |
HEALTH PROFESSIONAL |
||||
DEVICE MODEL NUMBER |
CESK |
||||
DEVICE CATALOGUE NUMBER |
555563 |
||||
DEVICE LOT NUMBER |
231300 |
||||
WAS DEVICE AVAILABLE FOR EVALUATION? |
NO |
||||
IS THE REPORTER A HEALTH PROFESSIONAL? |
YES |
||||
WAS THE REPORT SENT TO FDA? |
NO |
||||
DEVICE AGE |
UNKNOWN |
||||
EVENT LOCATION |
HOSPITAL |
||||
DATE MANUFACTURER RECEIVED |
02/09/1998 |
||||
WAS DEVICE EVALUATED BY MANUFACTURER? |
DEVICE NOT RETURNED TO MANUFACTURER |
||||
IS THE DEVICE SINGLE USE? |
YES |
||||
TYPE OF DEVICE USAGE |
UNKNOWN |
||||
PATIENT OUTCOME |
REQUIRED INTERVENTION |
ADVERSE EVENT OR PRODUCT PROBLEM DESCRIPTION |
REPORT DATE: 02/19/1998 MDR TEXT KEY: 457407 Patient Sequence Number: 1 |
CATHETER BROKE OFF WHEN BEING REMOVED FROM THE PT. PT RETURNED TO SURGERY TO HAVE THE CATHETER REMOVED. |
|
ADDITIONAL MANUFACTURER NARRATIVE |
REPORT DATE: 02/20/1998 MDR TEXT KEY: 457414 |
NO CONCLUSION CAN BE DRAWN SINCE THE DEFECTIVE PRODUCT WAS NOT RETURNED FOR EVALUATION. IT SHOULD BE NOTED THAT THE LABELING ON THE TRAY STATES, "DO NOT WITHDRAW CATHETER THROUGH THE NEEDLE BECAUSE OF POSSIBLE DANGER OF SHEARING". NO FURTHER INFORMATION IS AVAILABLE ON THE PT'S STATUS. DISCLAIMER: B. BRAUN MED INC IS SUBMITTING THIS REPORT TO THE FDA IN ACCORDANCE WITH THE FEDERAL REGISTER, 21 CFR PART 803 (MEDICAL DEVICE REPORTING) DATED DECEMBER 11, 1995. B. BRAUN MED INC DOES NOT INTEND THIS SUBMISSION TO BE USED IN ANY WAY AS AN ADMISSION THAT THE REPORTED INCIDENT ACTUALLY CAUSED OR CONTRIBUTED TO ANY DEATH OR SERIOUS INJURY. THIS INFORMATION HAS NOT BEEN VERIFIED FOR ACCURACY, COMPLETENESS OR ANY CASUAL RELATIONSHIPS TO DEVICES MFG OR DISTRIBUTED BY B. BRAUN MED INC. |
|
ADDITIONAL MANUFACTURER NARRATIVE |
REPORT DATE: 02/19/1998 MDR TEXT KEY: 498823 |
THIS FOLLOW-UP IS BEING FILED BECAUSE ADDITIONAL PRODUCT INFO WAS RECEIVED FROM THE FACILITY. THE ADDITIONAL INFO DOES NOT ALTER THE CONCLUSION OF THIS REPORT. |
71.
BRAND NAME |
PERIFIX |
|||
TYPE OF DEVICE |
PERIFIX CONTINUOUS EPIDURAL CUSTOM TRAY |
|||
BASELINE BRAND NAME |
PERIFIX |
|||
BASELINE GENERIC NAME |
CUSTOM EPIDURAL KIT |
|||
BASELINE CATALOGUE NUMBER |
555079 |
|||
BASELINE MODEL NUMBER |
CESK |
|||
BASELINE DEVICE FAMILY |
CONTINUOUS EPIDURAL KITS |
|||
BASELINE DEVICE 510(K) NUMBER |
K840179 |
|||
BASELINE SHELF LIFE INFORMATION |
YES |
|||
IS BASELINE PMA NUMBER PROVIDED?</< TH> |
NO |
|||
BASELINE PREAMENDMENT? |
NO |
|||
TRANSITIONAL? |
NO |
|||
510(K) EXEMPT? |
NO |
|||
SHELF LIFE(Months) |
12 |
|||
DATE FIRST MARKETED |
02/24/1984 |
|||
MANUFACTURER (Section D) |
|
|||
DEVICE EVENT KEY |
143737 |
|||
MDR REPORT KEY |
147491 |
|||
EVENT KEY |
138454 |
|||
REPORT NUMBER |
147491 |
|||
DEVICE SEQUENCE NUMBER |
1 |
|||
PRODUCT CODE |
CAZ |
|||
REPORT SOURCE |
USER FACILITY |
|||
TYPE OF REPORT |
INITIAL |
|||
REPORT DATE |
01/15/1998,01/29/1998 |
|||
1 DEVICE WAS INVOLVED IN THE EVENT |
|
|||
1 PATIENT WAS INVOLVED IN THE EVENT |
|
|||
DATE FDA RECEIVED |
02/03/1998 |
|||
IS THIS AN ADVERSE EVENT REPORT? |
YES |
|||
IS THIS A PRODUCT PROBLEM REPORT? |
NO |
|||
DEVICE OPERATOR |
HEALTH PROFESSIONAL |
|||
DEVICE EXPIRATION DATE |
02/01/1999 |
|||
DEVICE MODEL NUMBER |
CESK |
|||
DEVICE CATALOGUE NUMBER |
555067 |
|||
DEVICE LOT NUMBER |
070450 |
|||
WAS DEVICE AVAILABLE FOR EVALUATION? |
NO |
|||
IS THE REPORTER A HEALTH PROFESSIONAL? |
YES |
|||
WAS THE REPORT SENT TO FDA? |
NO |
|||
DISTRIBUTOR FACILITY AWARE DATE |
01/12/1998 |
|||
EVENT LOCATION |
HOSPITAL |
|||
PATIENT OUTCOME |
OTHER |
ADVERSE EVENT OR PRODUCT PROBLEM DESCRIPTION |
REPORT DATE: 01/15/1998 MDR TEXT KEY: 447129 Patient Sequence Number: 1 |
ORIGINAL REPORT FROM USER/FACILITY STATED: "PT ADMITTED TO THE HOSPITAL FOR NORMAL DELIVERY. AN EPIDURAL CATHETER WAS PLACED TO ADMINISTER MEDICATION. POSITIVE HEME THROUGH CATHETER UPON PASSAGE. UPON WITHDRAWAL OF THE CATHETER, APPROX 5 CM OF THE CATHETER SHEARED OFF INTO THE EPIDURAL SPACE. POTENTIAL FOR SURGICAL INTERVENTION IN THE FUTURE." |
72.
BRAND NAME |
PERIFIX |
|||
TYPE OF DEVICE |
CE TRAY |
|||
MANUFACTURER (Section D) |
|
|||
DEVICE EVENT KEY |
127417 |
|||
MDR REPORT KEY |
130278 |
|||
EVENT KEY |
122499 |
|||
REPORT NUMBER |
130278 |
|||
DEVICE SEQUENCE NUMBER |
1 |
|||
PRODUCT CODE |
LRP |
|||
REPORT SOURCE |
USER FACILITY |
|||
TYPE OF REPORT |
INITIAL |
|||
REPORT DATE |
10/29/1997 |
|||
1 DEVICE WAS INVOLVED IN THE EVENT |
|
|||
1 PATIENT WAS INVOLVED IN THE EVENT |
|
|||
DATE FDA RECEIVED |
11/03/1997 |
|||
IS THIS AN ADVERSE EVENT REPORT? |
YES |
|||
IS THIS A PRODUCT PROBLEM REPORT? |
NO |
|||
DEVICE OPERATOR |
HEALTH PROFESSIONAL |
|||
DEVICE EXPIRATION DATE |
02/02/2000 |
|||
DEVICE MODEL NUMBER |
CE18TB |
|||
DEVICE CATALOGUE NUMBER |
332222 |
|||
DEVICE LOT NUMBER |
70, 062790, OR 034940 |
|||
WAS DEVICE AVAILABLE FOR EVALUATION? |
NO |
|||
IS THE REPORTER A HEALTH PROFESSIONAL? |
YES |
|||
WAS THE REPORT SENT TO FDA? |
NO |
|||
DISTRIBUTOR FACILITY AWARE DATE |
10/03/1997 |
|||
DEVICE AGE |
UNKNOWN |
|||
EVENT LOCATION |
HOSPITAL |
|||
PATIENT OUTCOME |
REQUIRED INTERVENTION |
ADVERSE EVENT OR PRODUCT PROBLEM DESCRIPTION |
REPORT DATE: 10/29/1997 MDR TEXT KEY: 383908 Patient Sequence Number: 1 |
PT UNDERWENT A CAUDAL EPIDURAL STEROID INJECTION ON 10/3/97. THE CATHETER WAS WITHDRAWN AND THE ANESTHESIOLOGIST NOTED THAT THE CATHETER TIP APPEARED TO BE MISSING. THE DR MEASURED WITH ANOTHER CATHETER AND FOUND THAT ONE CM OF THE CATHETER REMAINED IN THE PT. PT WAS INFORMED. |
73.
BRAND NAME |
PERIFIX |
|||
TYPE OF DEVICE |
CE TRAY |
|||
BASELINE BRAND NAME |
PERIFIX |
|||
BASELINE GENERIC NAME |
CONTINUOUS EPIDURAL KIT |
|||
BASELINE CATALOGUE NUMBER |
332221 |
|||
BASELINE MODEL NUMBER |
CE17TK |
|||
BASELINE DEVICE FAMILY |
CONTINUOUS EPIDURAL KITS |
|||
BASELINE DEVICE 510(K) NUMBER |
K840179 |
|||
BASELINE SHELF LIFE INFORMATION |
YES |
|||
IS BASELINE PMA NUMBER PROVIDED?</< TH> |
NO |
|||
BASELINE PREAMENDMENT? |
NO |
|||
TRANSITIONAL? |
NO |
|||
510(K) EXEMPT? |
NO |
|||
SHELF LIFE(Months) |
12 |
|||
MANUFACTURER (Section D) |
|
|||
DEVICE EVENT KEY |
110151 |
|||
MDR REPORT KEY |
112188 |
|||
EVENT KEY |
105482 |
|||
REPORT NUMBER |
112188 |
|||
DEVICE SEQUENCE NUMBER |
1 |
|||
PRODUCT CODE |
CAZ |
|||
REPORT SOURCE |
USER FACILITY |
|||
TYPE OF REPORT |
INITIAL |
|||
REPORT DATE |
06/30/1997,08/08/1997 |
|||
1 DEVICE WAS INVOLVED IN THE EVENT |
|
|||
1 PATIENT WAS INVOLVED IN THE EVENT |
|
|||
DATE FDA RECEIVED |
08/08/1997 |
|||
IS THIS AN ADVERSE EVENT REPORT? |
YES |
|||
IS THIS A PRODUCT PROBLEM REPORT? |
NO |
|||
DEVICE OPERATOR |
HEALTH PROFESSIONAL |
|||
DEVICE EXPIRATION DATE |
10/01/1998 |
|||
DEVICE MODEL NUMBER |
CE17TK |
|||
DEVICE CATALOGUE NUMBER |
332221 |
|||
DEVICE LOT NUMBER |
880010 |
|||
WAS DEVICE AVAILABLE FOR EVALUATION? |
YES |
|||
IS THE REPORTER A HEALTH PROFESSIONAL? |
YES |
|||
WAS THE REPORT SENT TO FDA? |
YES |
|||
DISTRIBUTOR FACILITY AWARE DATE |
06/23/1997 |
|||
EVENT LOCATION |
HOSPITAL |
|||
PATIENT OUTCOME |
REQUIRED INTERVENTION |
ADVERSE EVENT OR PRODUCT PROBLEM DESCRIPTION |
REPORT DATE: 06/30/1997 MDR TEXT KEY: 315521 Patient Sequence Number: 1 |
DURING PERFORMANCE OF EPIDURAL STEROID INJECTION USING #17 TOUHY NEEDLE AND GLASS SYRINGE FILLED WITH AIR AND LOSS OF RESISTANCE TECHNIQUE, CRNA HAD DIFFICULTY IDENTIFYING EPIDURAL SPACE AT 2 LEVELS, PLACED SALINE ON BARREL OF SYRINGE FOR LUBRICATION AND DISCOVERED THE SYRINGE WAS LEAKING BETWEEN BARREL AND HUB. CHANGED SYRINGES AND WAS SUCCESSFUL ON FIRST ATTEMPT-NEGATIVE ASPIRATION, NEGATIVE TEST DOSE. GAVE TRIAMCINOLONE (120 MG) AND MARCAINE (15 MG) AND THE PT DEVELOPED DENSE BLOCK T11. CRNA BELIEVED THIS TO BE MIXED SAB/EPIDURAL BLOCK 2 DEGREES TO DURAL PUNCTURE THAT WAS UNRECOGNIZED DURING ATTEMPTS WITH DEFECTIVE SYRINGE. (AT NO TIME WAS SPINAL FLUID IDENTIFIED.) DENSE BLOCK CAUSED A SYMPTOMATIC DECREASE IN BLOOD PRESSURE REQUIRING EPHEDRINE, IV FLUIDS, AND PROLONGED RECOVERY ROOM/AMBULATORY PROCEDURE TIME. PT WAS DISCHARGED HOME LATER THE SAME DAY. |
74.
BRAND NAME |
PERIFIX CONTINUOUS EPIDURAL ANESTHESIA TRAY |
|||
TYPE OF DEVICE |
EPIDURAL ANESTHESIA TRAY |
|||
BASELINE BRAND NAME |
NA |
|||
BASELINE GENERIC NAME |
CONTINUOUS EPIDURAL KIT |
|||
BASELINE CATALOGUE NUMBER |
551523 |
|||
BASELINE MODEL NUMBER |
CESK |
|||
BASELINE DEVICE FAMILY |
CONTINUOUS EPIDURAL KIT |
|||
BASELINE DEVICE 510(K) NUMBER |
K840179 |
|||
BASELINE SHELF LIFE INFORMATION |
YES |
|||
IS BASELINE PMA NUMBER PROVIDED?</< TH> |
NO |
|||
BASELINE PREAMENDMENT? |
NO |
|||
TRANSITIONAL? |
NO |
|||
510(K) EXEMPT? |
NO |
|||
SHELF LIFE(Months) |
12 |
|||
DATE FIRST MARKETED |
02/24/1984 |
|||
MANUFACTURER (Section D) |
|
|||
DEVICE EVENT KEY |
105357 |
|||
MDR REPORT KEY |
107180 |
|||
EVENT KEY |
100752 |
|||
REPORT NUMBER |
107180 |
|||
DEVICE SEQUENCE NUMBER |
1 |
|||
PRODUCT CODE |
CAZ |
|||
REPORT SOURCE |
VOLUNTARY |
|||
REPORT DATE |
06/16/1997 |
|||
1 DEVICE WAS INVOLVED IN THE EVENT |
|
|||
1 PATIENT WAS INVOLVED IN THE EVENT |
|
|||
DATE FDA RECEIVED |
07/23/1997 |
|||
IS THIS AN ADVERSE EVENT REPORT? |
NO |
|||
IS THIS A PRODUCT PROBLEM REPORT? |
YES |
|||
DEVICE OPERATOR |
HEALTH PROFESSIONAL |
|||
DEVICE MODEL NUMBER |
CE18TK |
|||
DEVICE CATALOGUE NUMBER |
332220 |
|||
DEVICE LOT NUMBER |
929860 |
|||
WAS DEVICE AVAILABLE FOR EVALUATION? |
YES |
|||
DATE RETURNED TO MANUFACTURER |
06/18/1997 |
|||
PATIENT OUTCOME |
OTHER |
ADVERSE EVENT OR PRODUCT PROBLEM DESCRIPTION |
REPORT DATE: 06/16/1997 MDR TEXT KEY: 298254 Patient Sequence Number: 1 |
IN THE OPERATING ROOM THE PHYSICIAN OPENED A SEALED EPIDURAL TRAY AND FOUND A DEAD FLY IN THE TRAY. |
75.
BRAND NAME |
PERIFIX |
||||
TYPE OF DEVICE |
CE TRAY |
||||
BASELINE BRAND NAME |
PERIFIX |
||||
BASELINE GENERIC NAME |
CONTINUOUS EPIDURAL KIT |
||||
BASELINE CATALOGUE NUMBER |
332220 |
||||
BASELINE MODEL NUMBER |
CE-18TK |
||||
BASELINE DEVICE FAMILY |
CONTINUOUS EPIDURAL KITS |
||||
BASELINE DEVICE 510(K) NUMBER |
K840179 |
||||
BASELINE SHELF LIFE INFORMATION |
YES |
||||
IS BASELINE PMA NUMBER PROVIDED?</< TH> |
NO |
||||
BASELINE PREAMENDMENT? |
NO |
||||
TRANSITIONAL? |
NO |
||||
510(K) EXEMPT? |
NO |
||||
SHELF LIFE(Months) |
12 |
||||
DATE FIRST MARKETED |
02/24/1984 |
||||
MANUFACTURER (Section G) |
|
||||
MANUFACTURER CONTACT |
|
||||
DEVICE EVENT KEY |
92473 |
||||
MDR REPORT KEY |
106215 |
||||
EVENT KEY |
88080 |
||||
REPORT NUMBER |
2523676-1997-00013 |
||||
DEVICE SEQUENCE NUMBER |
1 |
||||
PRODUCT CODE |
CAZ |
||||
REPORT SOURCE |
MANUFACTURER |
||||
SOURCE TYPE |
USER FACILITY |
||||
EVENT TYPE |
INJURY |
||||
TYPE OF REPORT |
INITIAL |
||||
1 DEVICE WAS INVOLVED IN THE EVENT |
|
||||
1 PATIENT WAS INVOLVED IN THE EVENT |
|
||||
DATE FDA RECEIVED |
07/15/1997 |
||||
IS THIS AN ADVERSE EVENT REPORT? |
NO |
||||
WAS DEVICE AVAILABLE FOR EVALUATION? |
NO |
||||
WAS THE REPORT SENT TO FDA? |
YES |
||||
DATE MANUFACTURER RECEIVED |
06/16/1997 |
||||
WAS DEVICE EVALUATED BY MANUFACTURER? |
DEVICE NOT RETURNED TO MANUFACTURER |
||||
IS THE DEVICE SINGLE USE? |
YES |
||||
TYPE OF DEVICE USAGE |
INITIAL |
ADDITIONAL MANUFACTURER NARRATIVE |
REPORT DATE: 07/15/1997 MDR TEXT KEY: 294901 |
NO FURTHER INFO IS AVAILABLE ON THE PT'S STATUS. DISCLAIMER: B. BRAUN MEDICAL INC. IS SUBMITTING THIS REPORT TO THE FDA IN ACCORDANCE WITH THE FEDERAL REGISTER, 21 CFR PART 803 (MEDICAL DEVICE REPORTING) DATED 12/11/95. B. BRAUN MEDICAL INC. DOES NOT INTEND THIS SUBMISSION TO BE USED IN ANY WAY AS AN ADMISSION THAT THE REPORTED INCIDENT ACTUALLY CAUSED OR CONTRIBUTED TO ANY DEATH OR SERIOUS INJURY. THIS INFORMATION HAS NOT BEEN VERIFIED FOR ACCURACY, COMPLETENESS OR ANY CAUSAL RELATIONSHIPS TO DEVICE MFG OR DISTRIBUTED BY B. BRAUN MEDICAL, INC. |
76.
BRAND NAME |
PERIFIX |
||||
TYPE OF DEVICE |
EPIDURAL ANESTHESIA CATHETER |
||||
MANUFACTURER (Section D) |
|
||||
DEVICE EVENT KEY |
62160 |
||||
MDR REPORT KEY |
61814 |
||||
EVENT KEY |
58130 |
||||
REPORT NUMBER |
61814 |
||||
DEVICE SEQUENCE NUMBER |
1 |
||||
PRODUCT CODE |
BSO |
||||
REPORT SOURCE |
USER FACILITY |
||||
TYPE OF REPORT |
INITIAL |
||||
REPORT DATE |
01/07/1997 |
||||
1 DEVICE WAS INVOLVED IN THE EVENT |
|
||||
1 PATIENT WAS INVOLVED IN THE EVENT |
|
||||
DATE FDA RECEIVED |
01/10/1997 |
||||
IS THIS AN ADVERSE EVENT REPORT? |
YES |
||||
IS THIS A PRODUCT PROBLEM REPORT? |
YES |
||||
DEVICE OPERATOR |
HEALTH PROFESSIONAL |
||||
DEVICE EXPIRATION DATE |
02/01/1999 |
||||
DEVICE LOT NUMBER |
530480 |
||||
WAS DEVICE AVAILABLE FOR EVALUATION? |
YES |
||||
IS THE REPORTER A HEALTH PROFESSIONAL? |
NO |
||||
WAS THE REPORT SENT TO FDA? |
YES |
||||
DATE REPORT TO FDA |
01/08/1997 |
||||
DISTRIBUTOR FACILITY AWARE DATE |
01/01/1997 |
||||
DEVICE AGE |
2 DAY |
||||
EVENT LOCATION |
HOSPITAL |
||||
DATE REPORT TO MANUFACTURER |
01/08/1997 |
||||
PATIENT OUTCOME |
OTHER |
ADVERSE EVENT OR PRODUCT PROBLEM DESCRIPTION |
REPORT DATE: 01/07/1997 MDR TEXT KEY: 138536 Patient Sequence Number: 1 |
DURING AN EASY REMOVAL, STAFF NOTICED 7-10 CM OF CATHETER TIP WAS MISSING. FOREIGN BODY BELIEVED TO BE LOCATED IN T5-6 SOFT TISSUE ONLY ON MRI. PT ASYMPTOMATIC PER NEUROLOGY CONSULT. MAY BE NIDUS OF INFECTION SHOULD THE PT NEED CHEMOTHERAPY AT LATER DATE. |
77.
BRAND NAME |
PERIFIX CONTINOUS EPIDURAL ANESTHESIA TRAY |
||
TYPE OF DEVICE |
EPIDURAL CATHETER |
||
MANUFACTURER (Section F) |
|
||
MANUFACTURER (Section D) |
|
||
DEVICE EVENT KEY |
68546 |
||
MDR REPORT KEY |
68569 |
||
EVENT KEY |
64450 |
||
REPORT NUMBER |
68569 |
||
DEVICE SEQUENCE NUMBER |
1 |
||
PRODUCT CODE |
BSO |
||
REPORT SOURCE |
USER FACILITY |
||
TYPE OF REPORT |
INITIAL |
||
REPORT DATE |
05/30/1996 |
||
1 DEVICE WAS INVOLVED IN THE EVENT |
|
||
1 PATIENT WAS INVOLVED IN THE EVENT |
|
||
DATE FDA RECEIVED |
01/10/1997 |
||
IS THIS AN ADVERSE EVENT REPORT? |
NO |
||
IS THIS A PRODUCT PROBLEM REPORT? |
YES |
||
DEVICE OPERATOR |
HEALTH PROFESSIONAL |
||
DEVICE EXPIRATION DATE |
11/01/1997 |
||
DEVICE MODEL NUMBER |
CE-18TK |
||
DEVICE LOT NUMBER |
509780 |
||
WAS DEVICE AVAILABLE FOR EVALUATION? |
NO ANSWER PROVIDED |
||
IS THE REPORTER A HEALTH PROFESSIONAL? |
YES |
||
WAS THE REPORT SENT TO FDA? |
NO |
||
DISTRIBUTOR FACILITY AWARE DATE |
05/16/1996 |
||
EVENT LOCATION |
HOSPITAL |
||
DATE REPORT TO MANUFACTURER |
05/30/1996 |
ADVERSE EVENT OR PRODUCT PROBLEM DESCRIPTION |
REPORT DATE: 05/30/1996 MDR TEXT KEY: 161469 Patient Sequence Number: 1 |
DURING REMOVAL OF AN EPIDURAL CATHETER FROM AN OBSTETRICAL PT, CATHETER BROKE OFF INSIDE THE PT'S BACK. APPROX. 9CM APPEAR TO REMAIN IN THE PT'S BACK. CAT SCANS AND AN MRI PERFORMED DID NOT REVEAL FOREIGN BODY. |
78.
BRAND NAME |
PERIFIX CONTINUOUS EPIDURAL ANESTHESIA TRAY |
|||
TYPE OF DEVICE |
RADIOPAQUE EPIDURAL CATHETER 20 GA. CLOSED TIP |
|||
MANUFACTURER (Section F) |
|
|||
MANUFACTURER (Section D) |
|
|||
DEVICE EVENT KEY |
52263 |
|||
MDR REPORT KEY |
51602 |
|||
EVENT KEY |
48402 |
|||
REPORT NUMBER |
51602 |
|||
DEVICE SEQUENCE NUMBER |
1 |
|||
PRODUCT CODE |
CAZ |
|||
REPORT SOURCE |
USER FACILITY |
|||
TYPE OF REPORT |
INITIAL |
|||
REPORT DATE |
11/15/1996 |
|||
1 DEVICE WAS INVOLVED IN THE EVENT |
|
|||
1 PATIENT WAS INVOLVED IN THE EVENT |
|
|||
DATE FDA RECEIVED |
11/19/1996 |
|||
IS THIS AN ADVERSE EVENT REPORT? |
YES |
|||
IS THIS A PRODUCT PROBLEM REPORT? |
NO |
|||
DEVICE OPERATOR |
HEALTH PROFESSIONAL |
|||
DEVICE EXPIRATION DATE |
05/01/1998 |
|||
DEVICE MODEL NUMBER |
CE-1TTK |
|||
DEVICE CATALOGUE NUMBER |
332221 |
|||
DEVICE LOT NUMBER |
623770 |
|||
WAS DEVICE AVAILABLE FOR EVALUATION? |
YES |
|||
IS THE REPORTER A HEALTH PROFESSIONAL? |
YES |
|||
WAS THE REPORT SENT TO FDA? |
YES |
|||
DATE REPORT TO FDA |
11/15/1996 |
|||
DISTRIBUTOR FACILITY AWARE DATE |
11/08/1996 |
|||
DEVICE AGE |
UNKNOWN |
|||
EVENT LOCATION |
HOSPITAL |
|||
DATE REPORT TO MANUFACTURER |
11/14/1996 |
|||
PATIENT OUTCOME |
OTHER |
ADVERSE EVENT OR PRODUCT PROBLEM DESCRIPTION |
REPORT DATE: 11/15/1996 MDR TEXT KEY: 102975 Patient Sequence Number: 1 |
WHEN REMOVING EPIDURAL CATHETER, WHICH HAD BEEN IN PLACE ABOUT 24 HRS, APPROX 1/4 INCH OF TIP BROKE OFF IN THE PT. CONFIRMED BY CT. |
|
79.
BRAND NAME |
PERIFIX |
||||
TYPE OF DEVICE |
CUSTOM EPIDURAL KIT |
||||
BASELINE BRAND NAME |
PERIFIX |
||||
BASELINE GENERIC NAME |
CUSTOM EPIDURAL TRAY |
||||
BASELINE CATALOGUE NUMBER |
555861 |
||||
BASELINE MODEL NUMBER |
CESK |
||||
BASELINE DEVICE FAMILY |
CONTINUOUS EPIDURAL TRAYS |
||||
BASELINE DEVICE 510(K) NUMBER |
K813186 |
||||
BASELINE SHELF LIFE INFORMATION |
YES |
||||
IS BASELINE PMA NUMBER PROVIDED?</< TH> |
NO |
||||
BASELINE PREAMENDMENT? |
NO |
||||
TRANSITIONAL? |
NO |
||||
510(K) EXEMPT? |
NO |
||||
SHELF LIFE(Months) |
12 |
||||
DATE FIRST MARKETED |
12/03/1981 |
||||
MANUFACTURER (Section F) |
|
||||
MANUFACTURER (Section D) |
|
||||
MANUFACTURER (Section G) |
|
||||
MANUFACTURER CONTACT |
|
||||
DEVICE EVENT KEY |
45638 |
||||
MDR REPORT KEY |
44727 |
||||
EVENT KEY |
41927 |
||||
REPORT NUMBER |
2523676-1996-00003 |
||||
DEVICE SEQUENCE NUMBER |
1 |
||||
PRODUCT CODE |
CAZ |
||||
REPORT SOURCE |
MANUFACTURER |
||||
SOURCE TYPE |
HEALTH PROFESSIONAL |
||||
EVENT TYPE |
MALFUNCTION |
||||
TYPE OF REPORT |
INITIAL |
||||
REPORT DATE |
09/09/1996 |
||||
1 DEVICE WAS INVOLVED IN THE EVENT |
|
||||
1 PATIENT WAS INVOLVED IN THE EVENT |
|
||||
DATE FDA RECEIVED |
10/21/1996 |
||||
IS THIS AN ADVERSE EVENT REPORT? |
NO |
||||
IS THIS A PRODUCT PROBLEM REPORT? |
YES |
||||
DEVICE OPERATOR |
HEALTH PROFESSIONAL |
||||
DEVICE MODEL NUMBER |
CESK |
||||
DEVICE CATALOGUE NUMBER |
555861 |
||||
WAS DEVICE AVAILABLE FOR EVALUATION? |
DEVICE NOT RETURNED TO MANUFACTURER |
||||
IS THE REPORTER A HEALTH PROFESSIONAL? |
YES |
||||
WAS THE REPORT SENT TO FDA? |
NO |
||||
DISTRIBUTOR FACILITY AWARE DATE |
09/09/1996 |
||||
DEVICE AGE |
UNKNOWN |
||||
EVENT LOCATION |
HOSPITAL |
||||
DATE MANUFACTURER RECEIVED |
09/27/1996 |
||||
WAS DEVICE EVALUATED BY MANUFACTURER? |
YES |
||||
IS THE DEVICE SINGLE USE? |
YES |
||||
TYPE OF DEVICE USAGE |
INITIAL |
ADVERSE EVENT OR PRODUCT PROBLEM DESCRIPTION |
REPORT DATE: 09/09/1996 MDR TEXT KEY: 79400 Patient Sequence Number: 1 |
WHILE NURSE WAS REMOVING EPIDURAL CATHETER, IT STARTED STRETCHING AND THE TIP SNAPPED OFF, REMAINING IN THE PT. |
|
ADDITIONAL MANUFACTURER NARRATIVE |
REPORT DATE: 10/21/1996 MDR TEXT KEY: 79402 |
IT SHOULD BE NOTED THAT THE LABELING ON THE TRAY STATES: "DO NOT WITHDRAW THE CATHETER THROUGH THE NEEDLE BECAUSE OF THE POSSIBLE DANGER OF SHEARING". NO FURTHER INFO IS AVAILABLE ON THE PT'S STATUS. DISCLAIMER: B BRAUN MEDICAL INC. IS SUBMITTING THIS REPORT TO THE FDA IN ACCORDANCE WITH THE FEDERAL REGISTER, 21 CFR PART 803 (MEDICAL DEVICE REPORTING) DATED 12/11/95. B.BRAUN MEDICAL INC. DOES NOT INTEND THIS SUBMISSION TO BE USED IN ANY WAY AS AN ADMISSION THAT THE REPORTED INCIDENT ACTUALLY CAUSED OR CONTRIBUTED TO ANY DEATH OR SERIOUS INJURY. THIS INFO HAS NOT BEEN VERIFIED FOR ACCURACY, COMPLETENESS OR ANY CAUSUAL RELATIONSHIPS TO DEVICES MANUFACTURED OR DISTRIBUTED BY B BRAUN MEDICAL INC. |
|
PATIENT TREATMENT DATA |
||||||
Date Received: 10/21/1996 Patient Sequence Number: 1 |
||||||
|
80.
BRAND NAME |
B.BRAUN MEDICAL INC. PERIFIX |
|||
TYPE OF DEVICE |
EPIDURAL CATHETER |
|||
MANUFACTURER (Section F) |
|
|||
MANUFACTURER (Section D) |
|
|||
DEVICE EVENT KEY |
85232 |
|||
MDR REPORT KEY |
86032 |
|||
EVENT KEY |
80925 |
|||
REPORT NUMBER |
86032 |
|||
DEVICE SEQUENCE NUMBER |
1 |
|||
PRODUCT CODE |
BSO |
|||
REPORT SOURCE |
USER FACILITY |
|||
TYPE OF REPORT |
INITIAL |
|||
REPORT DATE |
06/14/1996 |
|||
1 DEVICE WAS INVOLVED IN THE EVENT |
|
|||
1 PATIENT WAS INVOLVED IN THE EVENT |
|
|||
DATE FDA RECEIVED |
07/03/1996 |
|||
IS THIS AN ADVERSE EVENT REPORT? |
YES |
|||
IS THIS A PRODUCT PROBLEM REPORT? |
YES |
|||
DEVICE OPERATOR |
HEALTH PROFESSIONAL |
|||
WAS DEVICE AVAILABLE FOR EVALUATION? |
NO |
|||
IS THE REPORTER A HEALTH PROFESSIONAL? |
YES |
|||
WAS THE REPORT SENT TO FDA? |
NO |
|||
DISTRIBUTOR FACILITY AWARE DATE |
06/11/1996 |
|||
DEVICE AGE |
UNKNOWN |
|||
EVENT LOCATION |
HOSPITAL |
|||
DATE REPORT TO MANUFACTURER |
06/15/1996 |
|||
PATIENT OUTCOME |
OTHER |
ADVERSE EVENT OR PRODUCT PROBLEM DESCRIPTION |
REPORT DATE: 06/14/1996 MDR TEXT KEY: 222178 Patient Sequence Number: 1 |
PT DEVELOPED SEVERE PANCREATITIS AND UNDERWENT DEBRIDEMENT & DRAINAGE OF INFECTED PANCREATIC NECROSIS AND A FEEDING JEJUNOSTOMY. DURING THIS PROCEDURE AN EPIDURAL CATHETER WAS PLACED FOR PAIN CONTROL. WHEN THE EPIDURAL CATHETER WAS BEING WITHDRAWN, IT BROKE OFF AND 2-3 CM PIECE REMAINS IN THE EPIDURAL SPACE. FRAGMENT REMAINS IN PT. |
81.
BRAND NAME |
PERIFIX EPIDURAL CATHETER |
||
TYPE OF DEVICE |
EPIDURAL CATHETER |
||
MANUFACTURER (Section D) |
|
||
DEVICE EVENT KEY |
34378 |
||
MDR REPORT KEY |
33059 |
||
EVENT KEY |
31060 |
||
REPORT NUMBER |
33059 |
||
DEVICE SEQUENCE NUMBER |
1 |
||
PRODUCT CODE |
BSO |
||
REPORT SOURCE |
VOLUNTARY |
||
REPORT DATE |
04/18/1996 |
||
1 DEVICE WAS INVOLVED IN THE EVENT |
|
||
1 PATIENT WAS INVOLVED IN THE EVENT |
|
||
DATE FDA RECEIVED |
05/17/1996 |
||
IS THIS AN ADVERSE EVENT REPORT? |
YES |
||
IS THIS A PRODUCT PROBLEM REPORT? |
NO |
||
DEVICE OPERATOR |
HEALTH PROFESSIONAL |
||
DEVICE EXPIRATION DATE |
05/01/1997 |
||
DEVICE MODEL NUMBER |
332221 |
||
DEVICE LOT NUMBER |
348280 |
||
WAS DEVICE AVAILABLE FOR EVALUATION? |
YES |
||
PATIENT OUTCOME |
OTHER |
ADVERSE EVENT OR PRODUCT PROBLEM DESCRIPTION |
REPORT DATE: 04/18/1996 MDR TEXT KEY: 46366 Patient Sequence Number: 1 |
THE TIP OF AN EPIDURAL CATHETER REMAINED IN THE PT FOLLOWING SURGERY FOR BLADDER CANCER. THE PT IS ASYMPTOMATIC. |
82.
BRAND NAME |
PERIFIX SINGLE DOSE EPIDURAL ANESTHESIA TRAY |
||
TYPE OF DEVICE |
SYRINGE |
||
MANUFACTURER (Section F) |
|
||
MANUFACTURER (Section D) |
|
||
DEVICE EVENT KEY |
25061 |
||
MDR REPORT KEY |
24683 |
||
EVENT KEY |
22929 |
||
REPORT NUMBER |
24683 |
||
DEVICE SEQUENCE NUMBER |
1 |
||
PRODUCT CODE |
CAZ |
||
REPORT SOURCE |
USER FACILITY |
||
TYPE OF REPORT |
INITIAL |
||
REPORT DATE |
03/09/1995 |
||
1 DEVICE WAS INVOLVED IN THE EVENT |
|
||
1 PATIENT WAS INVOLVED IN THE EVENT |
|
||
DATE FDA RECEIVED |
07/31/1995 |
||
IS THIS AN ADVERSE EVENT REPORT? |
NO |
||
IS THIS A PRODUCT PROBLEM REPORT? |
YES |
||
DEVICE OPERATOR |
HEALTH PROFESSIONAL |
||
DEVICE EXPIRATION DATE |
06/01/1997 |
||
DEVICE LOT NUMBER |
017890 |
||
OTHER DEVICE ID NUMBER |
332251 |
||
WAS DEVICE AVAILABLE FOR EVALUATION? |
DEVICE NOT RETURNED TO MANUFACTURER |
||
DATE RETURNED TO MANUFACTURER |
03/09/1995 |
||
IS THE REPORTER A HEALTH PROFESSIONAL? |
NO |
||
WAS THE REPORT SENT TO FDA? |
NO |
||
DISTRIBUTOR FACILITY AWARE DATE |
03/09/1995 |
||
DEVICE AGE |
NO INFO |
||
EVENT LOCATION |
OUTPATIENT TREATMENT FACILITY |
||
DATE REPORT TO MANUFACTURER |
03/09/1995 |
||
PATIENT OUTCOME |
REQUIRED INTERVENTION |
ADVERSE EVENT OR PRODUCT PROBLEM DESCRIPTION |
REPORT DATE: 03/09/1995 MDR TEXT KEY: 33743 Patient Sequence Number: 1 |
PT PRESENTED FOR EPIDURAL BLOCK ONCE PROCEDURE COMPLETE, PHYSICIAN NOTICED WHAT APPEARS TO BE HAIR OR FIBER IN THE PLASTIC SYRINGE USED IN THE PROCEDURE. |
83.
BRAND NAME |
PERIFIX |
|||
TYPE OF DEVICE |
CESK - CUSTOM EPIDURAL ANESTHESIA CATHETER |
|||
MANUFACTURER (Section F) |
|
|||
MANUFACTURER (Section D) |
|
|||
DEVICE EVENT KEY |
26346 |
|||
MDR REPORT KEY |
25745 |
|||
EVENT KEY |
23973 |
|||
REPORT NUMBER |
25745 |
|||
DEVICE SEQUENCE NUMBER |
1 |
|||
PRODUCT CODE |
MAJ |
|||
REPORT SOURCE |
USER FACILITY |
|||
TYPE OF REPORT |
INITIAL |
|||
REPORT DATE |
11/25/1994 |
|||
1 DEVICE WAS INVOLVED IN THE EVENT |
|
|||
1 PATIENT WAS INVOLVED IN THE EVENT |
|
|||
DATE FDA RECEIVED |
01/19/1995 |
|||
IS THIS AN ADVERSE EVENT REPORT? |
NO |
|||
IS THIS A PRODUCT PROBLEM REPORT? |
YES |
|||
DEVICE OPERATOR |
HEALTH PROFESSIONAL |
|||
DEVICE LOT NUMBER |
#649210 |
|||
WAS DEVICE AVAILABLE FOR EVALUATION? |
DEVICE NOT RETURNED TO MANUFACTURER |
|||
IS THE REPORTER A HEALTH PROFESSIONAL? |
YES |
|||
WAS THE REPORT SENT TO FDA? |
NO |
|||
DISTRIBUTOR FACILITY AWARE DATE |
11/23/1994 |
|||
EVENT LOCATION |
INVALID DATA |
|||
DATE REPORT TO MANUFACTURER |
11/25/1994 |
|||
PATIENT OUTCOME |
OTHER |
ADVERSE EVENT OR PRODUCT PROBLEM DESCRIPTION |
REPORT DATE: 11/25/1994 MDR TEXT KEY: 35434 Patient Sequence Number: 1 |
EPIDURAL CATHETER PLACED FOR ANESTHETIC ADMINSTRATION AT L2 - L3. ENCOUNTERED RESISTANCE WHEN REMOVING THE CATHETER POST OPERATIVELY. 0.5 CM OF CATHETER RETAINED IN PATIENT WHEN CATHETER FINALLY REMOVED. NO UNTOWARD EFFECTS NOTED. |
84.
BRAND NAME |
PERIFIX EPIDURAL CATHETER |
||
TYPE OF DEVICE |
PERIFIX EPIDURAL CATHETER |
||
MANUFACTURER (Section D) |
|
||
DEVICE EVENT KEY |
17034 |
||
MDR REPORT KEY |
17101 |
||
EVENT KEY |
14397 |
||
REPORT NUMBER |
17101 |
||
DEVICE SEQUENCE NUMBER |
1 |
||
PRODUCT CODE |
BSO |
||
REPORT SOURCE |
VOLUNTARY |
||
REPORT DATE |
10/11/1994 |
||
1 DEVICE WAS INVOLVED IN THE EVENT |
|
||
1 PATIENT WAS INVOLVED IN THE EVENT |
|
||
DATE FDA RECEIVED |
10/24/1994 |
||
IS THIS AN ADVERSE EVENT REPORT? |
NO |
||
IS THIS A PRODUCT PROBLEM REPORT? |
YES |
||
DEVICE OPERATOR |
HEALTH PROFESSIONAL |
||
DEVICE LOT NUMBER |
899840 |
||
WAS DEVICE AVAILABLE FOR EVALUATION? |
YES |
||
PATIENT OUTCOME |
REQUIRED INTERVENTION |
ADVERSE EVENT OR PRODUCT PROBLEM DESCRIPTION |
REPORT DATE: 10/11/1994 MDR TEXT KEY: 19857 Patient Sequence Number: 1 |
PER NEUROSURGEON "PT UNDERWENT PERCUTANEOUS PLACEMENT OF AN EPIDURAL CATHETER FOR ANESTHESIA DURING UROLOGIC PROCEDURE AND UPON ATTEMPTING TO RETRIEVE THE CATHETER, THE DEVICE BECAME STRETCHED AND WHEN MEASURING IT IN COMPARISON TO THE EXPECTED LENGTH IT IS SHORTER. THE PRESUMPTION IS THAT A SMALL PORTION, PERHAPS SEVERAL INCHES OF THE CATHETER WAS LEFT IN THE SUBCUTANEOUS TISSUE. NO ASSOCIATED NEUROLOGIC DEFICITS. X-RAYS REVEALED NO RADIOGRAPHIC MATERIAL PRESENT." |
85.
BRAND NAME |
PERIFIX CONTINUOUS EPIDURAL ANESTHESIA TRAY |
|||
TYPE OF DEVICE |
EPIDURAL ANESTHESIA TRAY |
|||
BASELINE BRAND NAME |
PERIFIX |
|||
BASELINE GENERIC NAME |
CONTINUOUS EPIDURAL KIT |
|||
BASELINE CATALOGUE NUMBER |
332220 |
|||
BASELINE MODEL NUMBER |
CE-18TK |
|||
BASELINE DEVICE FAMILY |
CONTINUOUS EPIDURAL KITS |
|||
BASELINE DEVICE 510(K) NUMBER |
K840179 |
|||
BASELINE SHELF LIFE INFORMATION |
YES |
|||
IS BASELINE PMA NUMBER PROVIDED?</< TH> |
NO |
|||
BASELINE PREAMENDMENT? |
NO |
|||
TRANSITIONAL? |
NO |
|||
510(K) EXEMPT? |
NO |
|||
SHELF LIFE(Months) |
12 |
|||
DATE FIRST MARKETED |
02/24/1984 |
|||
MANUFACTURER (Section D) |
|
|||
DEVICE EVENT KEY |
92473 |
|||
MDR REPORT KEY |
93664 |
|||
EVENT KEY |
88080 |
|||
REPORT NUMBER |
93664 |
|||
DEVICE SEQUENCE NUMBER |
1 |
|||
PRODUCT CODE |
CAZ |
|||
REPORT SOURCE |
VOLUNTARY |
|||
REPORT DATE |
07/30/1994 |
|||
1 DEVICE WAS INVOLVED IN THE EVENT |
|
|||
1 PATIENT WAS INVOLVED IN THE EVENT |
|
|||
DATE FDA RECEIVED |
08/02/1994 |
|||
IS THIS AN ADVERSE EVENT REPORT? |
NO |
|||
IS THIS A PRODUCT PROBLEM REPORT? |
YES |
|||
DEVICE OPERATOR |
HEALTH PROFESSIONAL |
|||
DEVICE EXPIRATION DATE |
12/01/1995 |
|||
DEVICE MODEL NUMBER |
CE-18TK |
|||
DEVICE CATALOGUE NUMBER |
332220 |
|||
DEVICE LOT NUMBER |
806220 |
|||
WAS DEVICE AVAILABLE FOR EVALUATION? |
YES |
|||
PATIENT OUTCOME |
OTHER |
ADVERSE EVENT OR PRODUCT PROBLEM DESCRIPTION |
REPORT DATE: 07/30/1994 MDR TEXT KEY: 250529 Patient Sequence Number: 1 |
ON REMOVAL OF EPIDURAL CATHETER, A PORTION OF THE TIP APPEARED TO BE SHEARED OFF, REMAINED IN PLACE. SO FAR, NO COMPLICATIONS HAVE DEVELOPED AND NO INTERVENTION HAS BEEN REQUIRED. |
86.
BRAND NAME |
PERIFIX CUSTOM EPIDURAL ANESTHESIA TRAY |
|||
TYPE OF DEVICE |
EPIDURAL ANESTHESIA CATHETER |
|||
MANUFACTURER (Section F) |
|
|||
MANUFACTURER (Section D) |
|
|||
DEVICE EVENT KEY |
21106 |
|||
MDR REPORT KEY |
21132 |
|||
EVENT KEY |
19436 |
|||
REPORT NUMBER |
21132 |
|||
DEVICE SEQUENCE NUMBER |
1 |
|||
PRODUCT CODE |
GZD |
|||
REPORT SOURCE |
USER FACILITY |
|||
TYPE OF REPORT |
INITIAL |
|||
REPORT DATE |
06/27/1994 |
|||
1 DEVICE WAS INVOLVED IN THE EVENT |
|
|||
1 PATIENT WAS INVOLVED IN THE EVENT |
|
|||
DATE FDA RECEIVED |
07/28/1994 |
|||
IS THIS AN ADVERSE EVENT REPORT? |
NO |
|||
IS THIS A PRODUCT PROBLEM REPORT? |
YES |
|||
DEVICE OPERATOR |
HEALTH PROFESSIONAL |
|||
DEVICE CATALOGUE NUMBER |
S1550316 |
|||
DEVICE LOT NUMBER |
UNKNOWN |
|||
OTHER DEVICE ID NUMBER |
UNKNOWN |
|||
WAS DEVICE AVAILABLE FOR EVALUATION? |
NO |
|||
IS THE REPORTER A HEALTH PROFESSIONAL? |
YES |
|||
WAS THE REPORT SENT TO FDA? |
NO |
|||
DISTRIBUTOR FACILITY AWARE DATE |
06/14/1994 |
|||
EVENT LOCATION |
HOSPITAL |
|||
DATE REPORT TO MANUFACTURER |
06/27/1994 |
|||
PATIENT OUTCOME |
REQUIRED INTERVENTION |
ADVERSE EVENT OR PRODUCT PROBLEM DESCRIPTION |
REPORT DATE: 06/27/1994 MDR TEXT KEY: 27780 Patient Sequence Number: 1 |
6/13/94 EPIDURAL CATHETER INSERTED AT L1-2 WITH SUBCUTANEOUS TUNNELING FOR LEFT LOW BACK PAIN, HIP AND LEG PAIN. INFUSION STARTED IN PAIN CLINIC. LATER THAT EVENING SUBCUTANEOUS SWELLING WAS NOTED. APPEARED AFTER TESTING THE CATHETER WITH NORMAL SALINE THAT THERE WAS A HOLE IN THE CATHETER PROBABLY AS A RESULT OF THE TUNNELING. 6/13/94 EPIDURAL CATHETER WAS REMOVED INTACT. ON 6/14/94 A NEW EPIDURAL CATHETER WAS INSERTED AT L2-3 UNDER STERILE CONDITION AND PLACED SUBCUTANEOUSLY. PATIENT WAS DISCHARGED HOME IN SATISFACTORY CONDITION. DEVICE WAS DISCARDED AND IS NOT AVAILABLE FOR EVALUATION. |
87.
BRAND NAME |
PERIFIX |
||
TYPE OF DEVICE |
CUSTOM EPIDURAL ANESTHESIA CATHETER |
||
MANUFACTURER (Section F) |
|
||
MANUFACTURER (Section D) |
|
||
DEVICE EVENT KEY |
16866 |
||
MDR REPORT KEY |
16933 |
||
EVENT KEY |
14053 |
||
REPORT NUMBER |
16933 |
||
DEVICE SEQUENCE NUMBER |
1 |
||
PRODUCT CODE |
BSO |
||
REPORT SOURCE |
USER FACILITY |
||
TYPE OF REPORT |
INITIAL |
||
REPORT DATE |
07/26/1994 |
||
1 DEVICE WAS INVOLVED IN THE EVENT |
|
||
1 PATIENT WAS INVOLVED IN THE EVENT |
|
||
DATE FDA RECEIVED |
07/28/1994 |
||
IS THIS AN ADVERSE EVENT REPORT? |
NO |
||
DEVICE OPERATOR |
HEALTH PROFESSIONAL |
||
DEVICE EXPIRATION DATE |
10/01/1996 |
||
DEVICE MODEL NUMBER |
51550066 |
||
DEVICE LOT NUMBER |
718330, 649210 |
||
WAS DEVICE AVAILABLE FOR EVALUATION? |
DEVICE NOT RETURNED TO MANUFACTURER |
||
IS THE REPORTER A HEALTH PROFESSIONAL? |
YES |
||
WAS THE REPORT SENT TO FDA? |
NO |
||
EVENT LOCATION |
INVALID DATA |
||
PATIENT OUTCOME |
OTHER |
ADVERSE EVENT OR PRODUCT PROBLEM DESCRIPTION |
REPORT DATE: 07/26/1994 MDR TEXT KEY: 19372 Patient Sequence Number: 1 |
EPIDURAL CATHETER PLACED FOR ANESTHETIC ADMINISTRATION. WHEN NEEDLE WAS WITHDRAWN, CATHETER HAD SEVERED AT THE 8 CM MARK. PIECE OF CATHETER RETAINED. NO UNTOWARD EFFECTS NOTED. |
88.
BRAND NAME |
PERIFIX |
||
TYPE OF DEVICE |
EPIDURAL ANESTHESIA TRAY |
||
MANUFACTURER (Section F) |
|
||
MANUFACTURER (Section D) |
|
||
DEVICE EVENT KEY |
7738 |
||
MDR REPORT KEY |
8063 |
||
EVENT KEY |
11086 |
||
REPORT NUMBER |
8063 |
||
DEVICE SEQUENCE NUMBER |
1 |
||
PRODUCT CODE |
CAZ |
||
REPORT SOURCE |
USER FACILITY |
||
TYPE OF REPORT |
INITIAL |
||
REPORT DATE |
04/11/1994 |
||
1 DEVICE WAS INVOLVED IN THE EVENT |
|
||
1 PATIENT WAS INVOLVED IN THE EVENT |
|
||
DATE FDA RECEIVED |
04/11/1994 |
||
IS THIS AN ADVERSE EVENT REPORT? |
NO |
||
IS THIS A PRODUCT PROBLEM REPORT? |
YES |
||
DEVICE OPERATOR |
OTHER HEALTH CARE PROFESSIONAL |
||
DEVICE MODEL NUMBER |
CE-18TK |
||
DEVICE CATALOGUE NUMBER |
332220 |
||
WAS DEVICE AVAILABLE FOR EVALUATION? |
YES |
||
IS THE REPORTER A HEALTH PROFESSIONAL? |
UNKNOWN |
||
WAS THE REPORT SENT TO FDA? |
YES |
||
DATE REPORT TO FDA |
04/11/1994 |
||
DISTRIBUTOR FACILITY AWARE DATE |
03/02/1994 |
||
EVENT LOCATION |
HOSPITAL |
||
DATE REPORT TO MANUFACTURER |
04/05/1994 |
||
PATIENT OUTCOME |
OTHER |
ADVERSE EVENT OR PRODUCT PROBLEM DESCRIPTION |
REPORT DATE: 04/11/1994 MDR TEXT KEY: 14089 Patient Sequence Number: 1 |
THIS EVENT IS RELATED TO THE USE OF AN EPIDURAL CATHETER TRAY WHICH INCLUDES A RADIOPAQUE CATHETER AND AN 18 GA NEEDLE INTRODUCER. ORIGINALLY, IT WAS SUSPECTED THAT THE TIP (APPROX 3 CM) OF THE CATHETER HAD "BROKEN OFF" INSIDE THE PT AS THE CATHETER WAS REMOVED FROM THE PT. SUBSEQUENT X-RAYS AND AN MRI SHOWED NEGATIVE FOR THE MISSING CATHETER TIP. THOUGH MOST OF THE KIT PACKAGING AND MATERIALS USED DURING THE CASE WERE SAVED, THE TIP WAS NOT RECOVERED. THE KIT LABEL WAS ALSO INADVERTENTLY DESTROYED. POST EVALUATION OF THE CATHETER UNDER A HIGH-POWERED MICROSCOPE SHOWED THAT THE TIP HAD BEEN SLICED OFF. IT IS ASSUMED THAT THIS MAY HAVE HAPPENED AS THE CATHETER WAS WITHDRAWN BACK THROUGH THE INTRODUCING NEEDLE. FURTHER TESTING WITH ANOTHER CATHETER VERIFIED THAT THIS CAN HAPPEN IF THE CATHETER IS WITHDRAWN QUICKLY. DEVICE LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: SATISFACTORY CONDITION. THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT. INVALID DATA - ON DEVICE SERVICE/MAINTENANCE. NO DATA - REGARDING DATE LAST SERVICED. SERVICE PROVIDED BY: INVALID DATA. INVALID DATA - SERVICE RECORDS AVAILABILITY. NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED. DEVICE USED AS LABELED/INTENDED. DEVICE WAS EVALUATED AFTER THE EVENT. METHOD OF EVALUATION: ACTUAL DEVICE INVOLVED IN INCIDENT WAS EVALUATED, VISUAL EXAMINATION. RESULTS OF EVALUATION: DESIGN, UNANTICIPATED. CONCLUSION: DEVICE FAILURE OCCURRED BUT NOT RELATED TO EVENT, DEVICE EVALUATED AND ALLEGED FAILURE COULD NOT BE DUPLICATED. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: INVALID DATA. CORRECTIVE ACTIONS: USER EDUCATION PROVIDED. THE DEVICE WAS NOT DESTROYED/DISPOSED OF. |
89.
BRAND NAME |
PERIFIX |
||
TYPE OF DEVICE |
EPIDURAL ANESTHESIA TRAY |
||
MANUFACTURER (Section F) |
|
||
MANUFACTURER (Section D) |
|
||
DEVICE EVENT KEY |
7637 |
||
MDR REPORT KEY |
7961 |
||
EVENT KEY |
10677 |
||
REPORT NUMBER |
7961 |
||
DEVICE SEQUENCE NUMBER |
1 |
||
PRODUCT CODE |
BSO |
||
REPORT SOURCE |
USER FACILITY |
||
TYPE OF REPORT |
INITIAL |
||
REPORT DATE |
04/05/1994 |
||
1 DEVICE WAS INVOLVED IN THE EVENT |
|
||
1 PATIENT WAS INVOLVED IN THE EVENT |
|
||
DATE FDA RECEIVED |
04/06/1994 |
||
IS THIS AN ADVERSE EVENT REPORT? |
NO |
||
IS THIS A PRODUCT PROBLEM REPORT? |
YES |
||
DEVICE OPERATOR |
OTHER HEALTH CARE PROFESSIONAL |
||
DEVICE MODEL NUMBER |
CE-18TK |
||
DEVICE CATALOGUE NUMBER |
332220 |
||
WAS DEVICE AVAILABLE FOR EVALUATION? |
YES |
||
IS THE REPORTER A HEALTH PROFESSIONAL? |
UNKNOWN |
||
WAS THE REPORT SENT TO FDA? |
YES |
||
DATE REPORT TO FDA |
04/05/1994 |
||
DISTRIBUTOR FACILITY AWARE DATE |
03/02/1994 |
||
EVENT LOCATION |
HOSPITAL |
||
DATE REPORT TO MANUFACTURER |
04/05/1994 |
||
PATIENT OUTCOME |
OTHER |
ADVERSE EVENT OR PRODUCT PROBLEM DESCRIPTION |
REPORT DATE: 04/05/1994 MDR TEXT KEY: 13330 Patient Sequence Number: 1 |
THIS EVENT IS RELATED TO THE USE OF AN EPIDURAL CATHETER TRAY WHICH INCLUDES A RADIOPAQUE CATHETER AND A 18 GA NEEDLE INTRODUCER. ORIGINALLY IT WAS SUSPECTED THAT THE TIP, APPROX 3 CM, OF THE CATHETER HAD "BROKEN OFF" INSIDE THE PT AS THE CATHETER WAS REMOVED FROM THE PT. SUBSEQUENT X-RAYS AND AN MRI SHOWED NEGATIVE FOR THE MISSING CATHETER TIP. THOUGH MOST OF THE KIT PACKAGING AND MATERIALS USED DURING THE CASE WERE SAVED, THE TIP WAS NOT RECOVERED. THE KIT LABEL WAS ALSO INADVERTENTLY DESTROYED. POST EVALUATION OF THE CATHETER UNDER A HIGH-POWERED MICROSCOPE SHOWED THAT THE TIP HAD BEEN SLICED OFF. IT IS ASSUMED THAT THIS MAY HAVE HAPPENED AS THE CATHETER WAS WITHDRAWN BACK THROUGH THE INTRODUCING NEEDLE. FURTHER TESTING WITH ANOTHER CATHETER VERIFIED THAT THIS CAN HAPPEN IF THE CATHETER IS WITHDRAWN QUICKLY. DEVICE LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: SATISFACTORY CONDITION. THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT. INVALID DATA - ON DEVICE SERVICE/MAINTENANCE. NO DATA - REGARDING DATE LAST SERVICED. SERVICE PROVIDED BY: INVALID DATA. INVALID DATA - SERVICE RECORDS AVAILABILITY. NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED. DEVICE USED AS LABELED/INTENDED. DEVICE WAS EVALUATED AFTER THE EVENT. METHOD OF EVALUATION: ACTUAL DEVICE INVOLVED IN INCIDENT WAS EVALUATED, VISUAL EXAMINATION. RESULTS OF EVALUATION: DESIGN, UNANTICIPATED. CONCLUSION: DEVICE FAILURE OCCURRED BUT NOT RELATED TO EVENT, DEVICE EVALUATED AND ALLEGED FAILURE COULD NOT BE DUPLICATED. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: INVALID DATA. CORRECTIVE ACTIONS: USER EDUCATION PROVIDED. THE DEVICE WAS NOT DESTROYED/DISPOSED OF. |