SPROTTE SPINAL NEEDLE ADVERSE REPORTS
1.
BRAND NAME |
SPROTTE SPINAL TRAY |
||||
TYPE OF DEVICE |
SPINAL NEEDLE |
||||
MANUFACTURER (Section F) |
|
||||
MANUFACTURER (Section D) |
|
||||
DEVICE EVENT KEY |
404417 |
||||
MDR REPORT KEY |
415379 |
||||
EVENT KEY |
392807 |
||||
REPORT NUMBER |
415379 |
||||
DEVICE SEQUENCE NUMBER |
1 |
||||
PRODUCT CODE |
BSP |
||||
REPORT SOURCE |
USER FACILITY |
||||
TYPE OF REPORT |
INITIAL |
||||
REPORT DATE |
08/30/2002 |
||||
1 DEVICE WAS INVOLVED IN THE EVENT |
|
||||
1 PATIENT WAS INVOLVED IN THE EVENT |
|
||||
DATE FDA RECEIVED |
09/04/2002 |
||||
IS THIS AN ADVERSE EVENT REPORT? |
YES |
||||
IS THIS A PRODUCT PROBLEM REPORT? |
YES |
||||
DEVICE OPERATOR |
HEALTH PROFESSIONAL |
||||
DEVICE EXPIRATION DATE |
11/01/2003 |
||||
DEVICE MODEL NUMBER |
SP25BK |
||||
DEVICE CATALOGUE NUMBER |
333750 |
||||
DEVICE LOT NUMBER |
60315313 200 3-11 |
||||
WAS DEVICE AVAILABLE FOR EVALUATION? |
DEVICE NOT RETURNED TO MANUFACTURER |
||||
DATE RETURNED TO MANUFACTURER |
08/30/2002 |
||||
IS THE REPORTER A HEALTH PROFESSIONAL? |
YES |
||||
WAS THE REPORT SENT TO FDA? |
YES |
||||
DATE REPORT TO FDA |
08/12/2002 |
||||
DISTRIBUTOR FACILITY AWARE DATE |
07/17/2002 |
||||
EVENT LOCATION |
HOSPITAL |
||||
DATE REPORT TO MANUFACTURER |
07/17/2002 |
||||
PATIENT OUTCOME |
REQUIRED INTERVENTION |
ADVERSE EVENT OR PRODUCT PROBLEM DESCRIPTION |
REPORT DATE: 08/30/2002 MDR TEXT KEY: 1442849 Patient Sequence Number: 1 |
PT WAS UNDERGOING REPAIR OF INCISIONAL HERNIA UNDER SPINAL BLOCK AT L4-5. BETADINE PREP, 1% LIDO INTRODUCER NEEDLE PLACED. 25G SPROTTE NEEDLE PLACED WITHOUT CSF. WHEN NEEDLE WAS WITHDRAWN, HALF OF NEEDLE WAS LEFT IN PT. RETAINED PORTION OF NEEDLE WAS REMOVED WITH FLUOROSCOPY. |
2.
BRAND NAME |
SPROTTE SPINAL NEEDLE TRAY |
||||
TYPE OF DEVICE |
SPINAL NEEDLE TRAY |
||||
BASELINE BRAND NAME |
SPROTTE SPINAL NEEDLE TRAY |
||||
BASELINE GENERIC NAME |
SPINAL NEEDLE KIT |
||||
BASELINE CATALOGUE NUMBER |
333750 |
||||
BASELINE MODEL NUMBER |
SP25BK |
||||
BASELINE DEVICE FAMILY |
SPINAL NEEDLE KIT |
||||
BASELINE DEVICE 510(K) NUMBER |
K932569 |
||||
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 |
01/26/1994 |
||||
MANUFACTURER (Section F) |
|
||||
MANUFACTURER (Section D) |
|
||||
MANUFACTURER CONTACT |
|
||||
DEVICE EVENT KEY |
400665 |
||||
MDR REPORT KEY |
411652 |
||||
EVENT KEY |
389224 |
||||
REPORT NUMBER |
2523676-2002-00045 |
||||
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 |
08/09/2002 |
||||
1 DEVICE WAS INVOLVED IN THE EVENT |
|
||||
1 PATIENT WAS INVOLVED IN THE EVENT |
|
||||
DATE FDA RECEIVED |
08/19/2002 |
||||
IS THIS AN ADVERSE EVENT REPORT? |
YES |
||||
IS THIS A PRODUCT PROBLEM REPORT? |
NO |
||||
DEVICE OPERATOR |
HEALTH PROFESSIONAL |
||||
DEVICE EXPIRATION DATE |
11/30/2003 |
||||
DEVICE MODEL NUMBER |
SP25BK |
||||
DEVICE CATALOGUE NUMBER |
333750 |
||||
WAS DEVICE AVAILABLE FOR EVALUATION? |
YES |
||||
IS THE REPORTER A HEALTH PROFESSIONAL? |
YES |
||||
WAS THE REPORT SENT TO FDA? |
NO |
||||
DISTRIBUTOR FACILITY AWARE DATE |
07/17/2002 |
||||
DEVICE AGE |
UNKNOWN |
||||
EVENT LOCATION |
HOSPITAL |
||||
DATE MANUFACTURER RECEIVED |
07/17/2002 |
||||
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 |
ADDITIONAL MANUFACTURER NARRATIVE |
REPORT DATE: 08/09/2002 MDR TEXT KEY: 1430300 |
THE ACTUAL SAMPLE HAS NOT YET BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. BASED ON THE INFORMATION PROVIDED, NO SPECIFIC CONCLUSIONS CAN BE DRAWN. IF APPLICABLE, A FOLLOW UP REPORT WILL BE FILED WHEN THE SAMPLE IS RETURNED. |
|
ADVERSE EVENT OR PRODUCT PROBLEM DESCRIPTION |
REPORT DATE: 08/09/2002 MDR TEXT KEY: 1430297 Patient Sequence Number: 1 |
USER FACILITY REPORTS THE FOLLOWING: OBESE PATIENT UNDERGOING UMBILICAL REPAIR. SPINAL NEEDLE WAS INTRODUCED THROUGH INTRODUCER AND DOCTOR DETERMINED HE HAD NOT ENTERED SUBARACHNOID SPACE AND DECIDED TO WITHDRAW NEEDLE TO REPOSITION. DURING WITHDRAWAL OF SPINAL NEEDLE, NEEDLE BROKE APPROXIMATELY IN HALF, DISTAL HALF REMAINING IN PATIENT. THE FRAGMENT WAS SURGICALLY REMOVED. ACCORDING TO DOCTOR, THE PATIENT IS DOING WELL. |
3.
BRAND NAME |
SPROTTE SPINAL NEEDLE TRAY |
||
TYPE OF DEVICE |
ANESTHESIA AGENT - SPINAL NEEDLE TRAY |
||
MANUFACTURER (Section D) |
|
||
DEVICE EVENT KEY |
391600 |
||
MDR REPORT KEY |
402591 |
||
EVENT KEY |
380478 |
||
REPORT NUMBER |
402591 |
||
DEVICE SEQUENCE NUMBER |
1 |
||
PRODUCT CODE |
CAZ |
||
REPORT SOURCE |
VOLUNTARY |
||
REPORT DATE |
06/20/2002 |
||
1 DEVICE WAS INVOLVED IN THE EVENT |
|
||
1 PATIENT WAS INVOLVED IN THE EVENT |
|
||
DATE FDA RECEIVED |
06/26/2002 |
||
IS THIS AN ADVERSE EVENT REPORT? |
NO |
||
IS THIS A PRODUCT PROBLEM REPORT? |
YES |
||
DEVICE OPERATOR |
HEALTH PROFESSIONAL |
||
DEVICE EXPIRATION DATE |
11/01/2003 |
||
DEVICE LOT NUMBER |
60306444 |
||
WAS DEVICE AVAILABLE FOR EVALUATION? |
NO ANSWER PROVIDED |
||
PATIENT OUTCOME |
OTHER |
ADVERSE EVENT OR PRODUCT PROBLEM DESCRIPTION |
REPORT DATE: 06/20/2002 MDR TEXT KEY: 1398498 Patient Sequence Number: 1 |
PT SCHEDULED TO UNDERGO TOTAL KNEE REPLACEMENT WITH SPINAL ANESTHESIA. GOOD SPINAL TAP, NO RESULTS WITH ANESTHETIC AGENT. PT CONVERTED TO GENERAL ANESTHESIA DUE TO FAILED SPINAL. |
4.
BRAND NAME |
SPROTTE |
||||
TYPE OF DEVICE |
SPINAL NEEDLE |
||||
BASELINE BRAND NAME |
SPROTTE |
||||
BASELINE GENERIC NAME |
SPINAL NEEDLE |
||||
BASELINE CATALOGUE NUMBER |
333769 |
||||
BASELINE MODEL NUMBER |
SP27123 |
||||
BASELINE DEVICE FAMILY |
SPINAL NEEDLE |
||||
BASELINE DEVICE 510(K) NUMBER |
K932569 |
||||
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 |
01/26/1994 |
||||
MANUFACTURER (Section F) |
|
||||
MANUFACTURER (Section D) |
|
||||
MANUFACTURER CONTACT |
|
||||
DEVICE EVENT KEY |
351455 |
||||
MDR REPORT KEY |
362312 |
||||
EVENT KEY |
341566 |
||||
REPORT NUMBER |
2523676-2001-00055 |
||||
DEVICE SEQUENCE NUMBER |
1 |
||||
PRODUCT CODE |
BSP |
||||
REPORT SOURCE |
MANUFACTURER |
||||
SOURCE TYPE |
USER FACILITY |
||||
REMEDIAL ACTION |
OTHER |
||||
EVENT TYPE |
INJURY |
||||
TYPE OF REPORT |
INITIAL |
||||
REPORT DATE |
11/14/2001 |
||||
1 DEVICE WAS INVOLVED IN THE EVENT |
|
||||
1 PATIENT WAS INVOLVED IN THE EVENT |
|
||||
DATE FDA RECEIVED |
11/19/2001 |
||||
IS THIS AN ADVERSE EVENT REPORT? |
YES |
||||
IS THIS A PRODUCT PROBLEM REPORT? |
NO |
||||
DEVICE OPERATOR |
HEALTH PROFESSIONAL |
||||
DEVICE MODEL NUMBER |
SP27123 |
||||
DEVICE CATALOGUE NUMBER |
333769 |
||||
DEVICE LOT NUMBER |
60083531 |
||||
WAS DEVICE AVAILABLE FOR EVALUATION? |
YES |
||||
IS THE REPORTER A HEALTH PROFESSIONAL? |
YES |
||||
WAS THE REPORT SENT TO FDA? |
NO |
||||
DISTRIBUTOR FACILITY AWARE DATE |
10/19/2001 |
||||
DEVICE AGE |
1.5 YR |
||||
EVENT LOCATION |
HOSPITAL |
||||
DATE MANUFACTURER RECEIVED |
10/22/2001 |
||||
WAS DEVICE EVALUATED BY MANUFACTURER? |
YES |
||||
DATE DEVICE MANUFACTURED |
03/01/2000 |
||||
IS THE DEVICE SINGLE USE? |
YES |
||||
TYPE OF DEVICE USAGE |
INITIAL |
||||
PATIENT OUTCOME |
OTHER |
ADVERSE EVENT OR PRODUCT PROBLEM DESCRIPTION |
REPORT DATE: 11/14/2001 MDR TEXT KEY: 1258947 Patient Sequence Number: 1 |
THE USER FACILITY REPORTED THE FOLLOWING: "PERFORMING SPINAL ANESTHESIA ON A PT TWO ATTEMPTS AT ADVANCEMENT OF NEEDLE RESISTANCE WAS FELT. ON THIRD ATTEMPT TO ADVANCE NEEDLE, APPROX 1/2 INCH OF DISTAL END OF NEEDLE BROKE OFF. UNABLE TO REMOVE FRAGMENT IN PERI-SPINOUS MUSCLE. SCHEDULED PROCEDURE WAS COMPLETED WITHOUT FURTHER INCIDENT." |
|
ADDITIONAL MANUFACTURER NARRATIVE |
REPORT DATE: 11/19/2001 MDR TEXT KEY: 1258950 |
ONE USED SPINAL NEEDLE WAS RETURNED FOR EVAL. APPROX 14MM OF THE UNSHEATHED NEEDLE WAS MISSING. THE NEEDLE LENGTH MEASURED 109MM (SPECIFICATION IS 123MM +/- 1MM). INFO PROVIDED BY THE USER FACILITY INDICATES THAT RESISTANCE WAS FELT DURING INSERTION IN PT. IN ADDITION THE APPEARANCE OF THE BREAK SUGGESTS THAT THE NEEDLE WAS BENT BEYOND ITS INTENDED DESIGN CAPABILITIES WHICH CAUSED IT TO BREAK. THERE WAS NO INDICATION THAT THIS OCCURRENCE WAS THE RESULT OF THE PRODUCT MALFUNCTION. NO FURTHER INFO IS AVAILABLE ON THE PT'S STATUS. |
5.
BRAND NAME |
SPINAL 24G SPROTTE |
|||||
TYPE OF DEVICE |
REGIONAL ANESTHESIA TRAY |
|||||
BASELINE BRAND NAME |
SPINAL 24G SPROTTE |
|||||
BASELINE GENERIC NAME |
REGIONAL ANESTHESIA TRAY |
|||||
BASELINE CATALOGUE NUMBER |
15858 |
|||||
MANUFACTURER (Section F) |
|
|||||
MANUFACTURER (Section D) |
|
|||||
MANUFACTURER (Section G) |
|
|||||
MANUFACTURER CONTACT |
|
|||||
DEVICE EVENT KEY |
329218 |
|||||
MDR REPORT KEY |
339894 |
|||||
EVENT KEY |
320010 |
|||||
REPORT NUMBER |
1018381-2001-00050 |
|||||
DEVICE SEQUENCE NUMBER |
1 |
|||||
PRODUCT CODE |
CAZ |
|||||
REPORT SOURCE |
MANUFACTURER |
|||||
SOURCE TYPE |
HEALTH PROFESSIONAL |
|||||
EVENT TYPE |
INJURY |
|||||
TYPE OF REPORT |
INITIAL,FOLLOWUP |
|||||
REPORT DATE |
05/24/2001 |
|||||
1 DEVICE WAS INVOLVED IN THE EVENT |
|
|||||
1 PATIENT WAS INVOLVED IN THE EVENT |
|
|||||
DATE FDA RECEIVED |
06/29/2001 |
|||||
IS THIS AN ADVERSE EVENT REPORT? |
YES |
|||||
IS THIS A PRODUCT PROBLEM REPORT? |
NO |
|||||
DEVICE OPERATOR |
HEALTH PROFESSIONAL |
|||||
DEVICE CATALOGUE NUMBER |
15858 |
|||||
DEVICE LOT NUMBER |
66-571-Z1 |
|||||
WAS DEVICE AVAILABLE FOR EVALUATION? |
NO |
|||||
IS THE REPORTER A HEALTH PROFESSIONAL? |
YES |
|||||
WAS THE REPORT SENT TO FDA? |
NO |
|||||
DATE MANUFACTURER RECEIVED |
05/24/2001 |
|||||
WAS DEVICE EVALUATED BY MANUFACTURER? |
NO |
|||||
DATE DEVICE MANUFACTURED |
06/01/2000 |
|||||
IS THE DEVICE SINGLE USE? |
YES |
|||||
TYPE OF DEVICE USAGE |
INITIAL |
|||||
PATIENT OUTCOME |
REQUIRED INTERVENTION |
ADVERSE EVENT OR PRODUCT PROBLEM DESCRIPTION |
REPORT DATE: 05/24/2001 MDR TEXT KEY: 1176126 Patient Sequence Number: 1 |
REPORT RECEIVED OF A SPINAL NEEDLE BREAK DURING A C-SECTION PROCEDURE. THE CUSTOMER REPORTS THAT THE PT WAS IN THE OPERATING ROOM FOR A C-SECTION "WHEN THE SPROTTE NEEDLE BROKE OFF." THE PT WAS REPORTED TO BE "DOING FINE." THERE WAS NO REPORT OF ANY ADVERSE PT EFFECT. MULTIPLE ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE, BUT NO FURTHER INFO WAS RECEIVED. |
|
ADDITIONAL MANUFACTURER NARRATIVE |
REPORT DATE: 06/29/2001 MDR TEXT KEY: 1176129 |
THE DEVICE IS EXPECTED TO BE RETURNED FOR TESTING AND INVESTIGATION. IT HAS NOT YET BEEN RECEIVED. THIS REPORT REPRESENTS ALL THE INFO KNOWN BY THE RPTR UPON QUERY BY ABBOTT PERSONNEL. |
|
ADDITIONAL MANUFACTURER NARRATIVE |
REPORT DATE: 05/24/2001 MDR TEXT KEY: 1500411 |
IT WAS INITIALLY REPORTED THAT THE USED DEVICE WOULD BE RETURNED FOR ANALYSIS. HOWEVER, THE ACTUAL DEVICE INVOLVED IN THE REPORTED INCIDENT WAS NOT RECD. WE WERE UNABLE TO CONFIRM THE REPORTED INCIDENT DURING VISUAL EXAMINATION OF THE FILE SAMPLE FROM THE INVOLVED LOT NUMBER. A REVIEW OF THE BATCH RECORD REVEALED THE LOT MET PRODUCT SPECIFICATION REQUIREMENT. A REVIEW OF OUR PRODUCT SURVEILLANCE FILES REVEALED THIS LOT NUMBER RECD NO OTHER SIMILAR REPORTS. |
6.
BRAND NAME |
SPROTTE |
|||
TYPE OF DEVICE |
SPINAL NEEDLE |
|||
MANUFACTURER (Section D) |
|
|||
DEVICE EVENT KEY |
248763 |
|||
MDR REPORT KEY |
256886 |
|||
EVENT KEY |
240773 |
|||
REPORT NUMBER |
256886 |
|||
DEVICE SEQUENCE NUMBER |
1 |
|||
PRODUCT CODE |
BSP |
|||
REPORT SOURCE |
VOLUNTARY |
|||
REPORT DATE |
12/17/1999 |
|||
1 DEVICE WAS INVOLVED IN THE EVENT |
|
|||
1 PATIENT WAS INVOLVED IN THE EVENT |
|
|||
DATE FDA RECEIVED |
12/17/1999 |
|||
IS THIS AN ADVERSE EVENT REPORT? |
NO |
|||
IS THIS A PRODUCT PROBLEM REPORT? |
YES |
|||
DEVICE OPERATOR |
HEALTH PROFESSIONAL |
|||
DEVICE LOT NUMBER |
60044070 |
|||
OTHER DEVICE ID NUMBER |
2001-02 |
|||
WAS DEVICE AVAILABLE FOR EVALUATION? |
DEVICE NOT RETURNED TO MANUFACTURER |
|||
DATE RETURNED TO MANUFACTURER |
12/15/1999 |
|||
PATIENT OUTCOME |
OTHER |
ADVERSE EVENT OR PRODUCT PROBLEM DESCRIPTION |
REPORT DATE: 12/17/1999 MDR TEXT KEY: 871368 Patient Sequence Number: 1 |
SPINAL ANESTHESIA BEING ATTEMPTED IN PREPARATION FOR ARTHROSCOPY OF LEFT ANKLE. PT SLIGHTLY UNCOOPERATIVE, RAISING UP AND MOVING WITH THE SLIGHTEST TOUCH TO BACK. |
7.
BRAND NAME |
SPROTTE PENCIL POINT SPINAL NEEDLE (WITHOUT INTRODUCER) |
||||
TYPE OF DEVICE |
SPINAL NEEDLE |
||||
BASELINE BRAND NAME |
SPROTTE PENCIL POINT SPINAL NEEDLE |
||||
BASELINE GENERIC NAME |
SPINAL NEEDLE |
||||
BASELINE CATALOGUE NUMBER |
03115130A |
||||
BASELINE DEVICE FAMILY |
EPIDURAL NEEDLE |
||||
BASELINE DEVICE 510(K) NUMBER |
K911260 |
||||
BASELINE SHELF LIFE INFORMATION |
* |
||||
IS BASELINE PMA NUMBER PROVIDED?</< TH> |
NO |
||||
BASELINE PREAMENDMENT? |
NO |
||||
TRANSITIONAL? |
NO |
||||
510(K) EXEMPT? |
NO |
||||
MANUFACTURER (Section F) |
|
||||
MANUFACTURER (Section D) |
|
||||
MANUFACTURER (Section G) |
|
||||
MANUFACTURER CONTACT |
|
||||
DEVICE EVENT KEY |
223213 |
||||
MDR REPORT KEY |
230157 |
||||
EVENT KEY |
216058 |
||||
REPORT NUMBER |
2429473-1999-00058 |
||||
DEVICE SEQUENCE NUMBER |
1 |
||||
PRODUCT CODE |
GDM |
||||
REPORT SOURCE |
MANUFACTURER |
||||
SOURCE TYPE |
USER FACILITY |
||||
EVENT TYPE |
INJURY |
||||
TYPE OF REPORT |
INITIAL,FOLLOWUP |
||||
REPORT DATE |
06/29/1999 |
||||
1 DEVICE WAS INVOLVED IN THE EVENT |
|
||||
1 PATIENT WAS INVOLVED IN THE EVENT |
|
||||
DATE FDA RECEIVED |
07/01/1999 |
||||
IS THIS AN ADVERSE EVENT REPORT? |
YES |
||||
IS THIS A PRODUCT PROBLEM REPORT? |
YES |
||||
DEVICE OPERATOR |
HEALTH PROFESSIONAL |
||||
DEVICE CATALOGUE NUMBER |
03115130A |
||||
WAS DEVICE AVAILABLE FOR EVALUATION? |
YES |
||||
IS THE REPORTER A HEALTH PROFESSIONAL? |
UNKNOWN |
||||
WAS THE REPORT SENT TO FDA? |
NO |
||||
DATE MANUFACTURER RECEIVED |
06/17/1999 |
||||
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: 06/29/1999 MDR TEXT KEY: 767910 Patient Sequence Number: 1 |
IT WAS REPORTED THAT THE PT WAS UNDERGOING AN ELECTIVE CESAREAN SECTION UNDER SPINAL BLOCK ANESTHESIA. AN INTRODUCER WAS PLACED, AND THEN THE SPROTTE NEEDLE WAS PLACED. SPINAL FLUID WAS NOT OBTAINED; THE INTRODUCER AND NEEDLE WERE REMOVED. UPON REMOVAL, IT WAS NOTED THAT THE DISTAL PORTION OF THE NEEDLE WAS NOT REMOVED. AFTER THE PROCEDURE, THE PT UNDERWENT AN ADD'L PROCEDURE TO REMOVE THE TIP. NO FURTHER CONSEQUENCES WERE NOTED. |
|
ADDITIONAL MANUFACTURER NARRATIVE |
REPORT DATE: 06/29/1999 MDR TEXT KEY: 767913 |
DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN. |
|
ADDITIONAL MANUFACTURER NARRATIVE |
REPORT DATE: 06/29/1999 MDR TEXT KEY: 787394 |
DEVICE EVAL NOT POSSIBLE, AS ALLEGEDLY DEFECTIVE DEVICE HAS NOT BEEN RETURNED FOR MFR'S INVESTIGATION. |
8.
BRAND NAME |
SPROTTE PENCIL POINT SPINAL NEEDLE |
||||
TYPE OF DEVICE |
SPINAL NEEDLE |
||||
BASELINE BRAND NAME |
SPROTTE PENCIL POINT SPINAL NEEDLE |
||||
BASELINE GENERIC NAME |
SPROTTE NEEDLE |
||||
BASELINE CATALOGUE NUMBER |
00115130A |
||||
BASELINE DEVICE FAMILY |
SPROTTE, TUOHY NEEDLE |
||||
BASELINE DEVICE 510(K) NUMBER |
K911260 |
||||
BASELINE SHELF LIFE INFORMATION |
* |
||||
IS BASELINE PMA NUMBER PROVIDED?</< TH> |
NO |
||||
BASELINE PREAMENDMENT? |
NO |
||||
TRANSITIONAL? |
NO |
||||
510(K) EXEMPT? |
NO |
||||
MANUFACTURER (Section G) |
|
||||
MANUFACTURER CONTACT |
|
||||
DEVICE EVENT KEY |
85965 |
||||
MDR REPORT KEY |
90315 |
||||
EVENT KEY |
81654 |
||||
REPORT NUMBER |
2429473-1997-00045 |
||||
DEVICE SEQUENCE NUMBER |
1 |
||||
PRODUCT CODE |
BSP |
||||
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 |
05/09/1997 |
||||
IS THIS AN ADVERSE EVENT REPORT? |
NO |
||||
DEVICE OPERATOR |
HEALTH PROFESSIONAL |
||||
DEVICE CATALOGUE NUMBER |
00115130A |
||||
DEVICE LOT NUMBER |
299 |
||||
WAS DEVICE AVAILABLE FOR EVALUATION? |
YES |
||||
DATE MANUFACTURER RECEIVED |
05/08/1997 |
||||
WAS DEVICE EVALUATED BY MANUFACTURER? |
NO |
||||
IS THE DEVICE SINGLE USE? |
NO ANSWER PROVIDED |
||||
TYPE OF DEVICE USAGE |
UNKNOWN |
9.
BRAND NAME |
SPROTTE SPINAL NEEDLE |
|||
TYPE OF DEVICE |
SPINAL NEEDLE |
|||
BASELINE BRAND NAME |
SPROTTE PENCIL POINT SPINAL NEEDLE |
|||
BASELINE GENERIC NAME |
SPROTTE NEEDLE |
|||
BASELINE CATALOGUE NUMBER |
00115130A |
|||
BASELINE DEVICE FAMILY |
SPROTTE, TUOHY NEEDLE |
|||
BASELINE DEVICE 510(K) NUMBER |
K911260 |
|||
BASELINE SHELF LIFE INFORMATION |
* |
|||
IS BASELINE PMA NUMBER PROVIDED?</< TH> |
NO |
|||
BASELINE PREAMENDMENT? |
NO |
|||
TRANSITIONAL? |
NO |
|||
510(K) EXEMPT? |
NO |
|||
MANUFACTURER (Section D) |
|
|||
DEVICE EVENT KEY |
85965 |
|||
MDR REPORT KEY |
86780 |
|||
EVENT KEY |
81654 |
|||
REPORT NUMBER |
86780 |
|||
DEVICE SEQUENCE NUMBER |
1 |
|||
PRODUCT CODE |
BSP |
|||
REPORT SOURCE |
VOLUNTARY |
|||
REPORT DATE |
04/15/1997 |
|||
1 DEVICE WAS INVOLVED IN THE EVENT |
|
|||
1 PATIENT WAS INVOLVED IN THE EVENT |
|
|||
DATE FDA RECEIVED |
04/28/1997 |
|||
IS THIS AN ADVERSE EVENT REPORT? |
NO |
|||
IS THIS A PRODUCT PROBLEM REPORT? |
YES |
|||
DEVICE OPERATOR |
HEALTH PROFESSIONAL |
|||
DEVICE EXPIRATION DATE |
09/01/1999 |
|||
DEVICE LOT NUMBER |
299 |
|||
WAS DEVICE AVAILABLE FOR EVALUATION? |
NO ANSWER PROVIDED |
ADVERSE EVENT OR PRODUCT PROBLEM DESCRIPTION |
REPORT DATE: 04/15/1997 MDR TEXT KEY: 225055 Patient Sequence Number: 1 |
DURING ROUTINE PERFORMANCE OF A SPINAL ANESTHETIC FOR C-SECTION, THE NEEDLE SEPARATED AT THE HUB LEAVING ONLY THE METAL PART OF THE NEEDLE IN THE PT. AN INTRODUCER HAD BEEN USED AND THE PT WAS THIN SO IT WAS EASY TO RETRIEVE THE SEPARATED NEEDLE AND REINSERT A NEW NEEDLE. HOWEVER, IN A LARGE PT, THE SEPARATED NEEDLE COULD HAVE BEEN LOST TO RETRIEVAL UNDER THE SKIN AND SO, REQUIRING A MINOR SURGICAL PROCEDURE TO REMOVE IT. |
10.
BRAND NAME |
PAJUNK SPROTTE NEEDLE |
||||
TYPE OF DEVICE |
SPROTTE NEEDLE |
||||
MANUFACTURER (Section F) |
|
||||
MANUFACTURER (Section D) |
|
||||
DEVICE EVENT KEY |
36148 |
||||
MDR REPORT KEY |
34768 |
||||
EVENT KEY |
32665 |
||||
REPORT NUMBER |
34768 |
||||
DEVICE SEQUENCE NUMBER |
1 |
||||
PRODUCT CODE |
CAZ |
||||
REPORT SOURCE |
DISTRIBUTOR |
||||
TYPE OF REPORT |
INITIAL |
||||
REPORT DATE |
07/16/1996 |
||||
1 DEVICE WAS INVOLVED IN THE EVENT |
|
||||
1 PATIENT WAS INVOLVED IN THE EVENT |
|
||||
DATE FDA RECEIVED |
07/16/1996 |
||||
IS THIS AN ADVERSE EVENT REPORT? |
NO |
||||
IS THIS A PRODUCT PROBLEM REPORT? |
YES |
||||
DEVICE OPERATOR |
HEALTH PROFESSIONAL |
||||
DEVICE EXPIRATION DATE |
10/01/1998 |
||||
DEVICE CATALOGUE NUMBER |
04115130A |
||||
DEVICE LOT NUMBER |
263 |
||||
WAS DEVICE AVAILABLE FOR EVALUATION? |
YES |
||||
IS THE REPORTER A HEALTH PROFESSIONAL? |
NO |
||||
WAS THE REPORT SENT TO FDA? |
YES |
||||
DATE REPORT TO FDA |
07/16/1996 |
||||
DISTRIBUTOR FACILITY AWARE DATE |
07/16/1996 |
||||
DEVICE AGE |
UNKNOWN |
||||
EVENT LOCATION |
HOSPITAL |
||||
DATE REPORT TO MANUFACTURER |
07/16/1996 |
||||
PATIENT OUTCOME |
OTHER |
ADVERSE EVENT OR PRODUCT PROBLEM DESCRIPTION |
REPORT DATE: 07/16/1996 MDR TEXT KEY: 49467 Patient Sequence Number: 1 |
WHILE PLACING A COMBINED A SPINAL EPIDURAL, THE NEEDLE STYLET STUCK AND COULD NOT BE EASILY REMOVED FROM THE NEEDLE. |
11.
BRAND NAME |
SPROTTE NEEDLE |
|||
TYPE OF DEVICE |
24G SPINAL ANESTHESIA NEEDLE |
|||
MANUFACTURER (Section F) |
|
|||
MANUFACTURER (Section D) |
|
|||
DEVICE EVENT KEY |
10090 |
|||
MDR REPORT KEY |
10090 |
|||
EVENT KEY |
5390 |
|||
REPORT NUMBER |
10090 |
|||
DEVICE SEQUENCE NUMBER |
1 |
|||
PRODUCT CODE |
BSP |
|||
REPORT SOURCE |
USER FACILITY |
|||
TYPE OF REPORT |
INITIAL |
|||
REPORT DATE |
07/30/1993 |
|||
1 DEVICE WAS INVOLVED IN THE EVENT |
|
|||
1 PATIENT WAS INVOLVED IN THE EVENT |
|
|||
DATE FDA RECEIVED |
08/31/1993 |
|||
IS THIS AN ADVERSE EVENT REPORT? |
YES |
|||
IS THIS A PRODUCT PROBLEM REPORT? |
YES |
|||
DEVICE OPERATOR |
HEALTH PROFESSIONAL |
|||
DEVICE LOT NUMBER |
158 |
|||
WAS DEVICE AVAILABLE FOR EVALUATION? |
YES |
|||
IS THE REPORTER A HEALTH PROFESSIONAL? |
YES |
|||
WAS THE REPORT SENT TO FDA? |
NO |
|||
DISTRIBUTOR FACILITY AWARE DATE |
07/26/1993 |
|||
EVENT LOCATION |
HOSPITAL |
|||
DATE REPORT TO MANUFACTURER |
07/30/1993 |
|||
PATIENT OUTCOME |
OTHER |
ADVERSE EVENT OR PRODUCT PROBLEM DESCRIPTION |
REPORT DATE: 07/30/1993 MDR TEXT KEY: 5526 Patient Sequence Number: 1 |
24 GUAGE SPROTTLE NEEDLE, USED TO DELIVER SPINAL ANESTHESIA, BROKE OFF. 1-1/2" NEEDLE SEGMENT SURGICALLY REMOVED (UNDER LOCAL ANESTHESIA) WITH NO CLINICAL SEQUELAE TO PATIENT. SPINAL BEING ADMINISTERED POST DELIVERY IN PREPARATION FOR POST-PARTUM TUBAL LIGATION. NEEDLE BROKEN WITHDRAWAL P.P.T.L. CANCELLED. |
12.
BRAND NAME |
SPROTTE SPINAL NEEDLE 24 GAX3-1/2" |
||
TYPE OF DEVICE |
SPINAL NEEDLE |
||
MANUFACTURER (Section F) |
|
||
MANUFACTURER (Section D) |
|
||
DEVICE EVENT KEY |
1242 |
||
MDR REPORT KEY |
1298 |
||
EVENT KEY |
1112 |
||
REPORT NUMBER |
1298 |
||
DEVICE SEQUENCE NUMBER |
1 |
||
PRODUCT CODE |
BSP |
||
REPORT SOURCE |
USER FACILITY |
||
TYPE OF REPORT |
INITIAL |
||
REPORT DATE |
08/21/1992 |
||
1 DEVICE WAS INVOLVED IN THE EVENT |
|
||
1 PATIENT WAS INVOLVED IN THE EVENT |
|
||
DATE FDA RECEIVED |
09/01/1992 |
||
IS THIS AN ADVERSE EVENT REPORT? |
NO |
||
IS THIS A PRODUCT PROBLEM REPORT? |
YES |
||
DEVICE OPERATOR |
OTHER HEALTH CARE PROFESSIONAL |
||
DEVICE EXPIRATION DATE |
06/01/1997 |
||
DEVICE MODEL NUMBER |
NO. S-2490 |
||
DEVICE CATALOGUE NUMBER |
AD 2490 |
||
DEVICE LOT NUMBER |
154 |
||
OTHER DEVICE ID NUMBER |
PAT. NO. 3020926 |
||
WAS DEVICE AVAILABLE FOR EVALUATION? |
YES |
||
IS THE REPORTER A HEALTH PROFESSIONAL? |
UNKNOWN |
||
WAS THE REPORT SENT TO FDA? |
YES |
||
DATE REPORT TO FDA |
08/21/1992 |
||
DISTRIBUTOR FACILITY AWARE DATE |
08/11/1992 |
||
DEVICE AGE |
01-JUN-92 |
||
EVENT LOCATION |
HOSPITAL |
||
DATE REPORT TO MANUFACTURER |
08/17/1992 |
||
PATIENT OUTCOME |
OTHER |
ADVERSE EVENT OR PRODUCT PROBLEM DESCRIPTION |
REPORT DATE: 08/21/1992 MDR TEXT KEY: 1132 Patient Sequence Number: 1 |
AT APPROX. 0730 HOURS, 8/11/92, OPERATING RM #2, A SPINAL ANESTHETIC WAS ATTEMPTED ON A 36 YEAR OLD FEMALE USING A SPROTTE SPINAL NEEDLE, THROUGH A THINWALL INTRODUCER. THE INTRODUCER WAS POSITIONED L2-3 INTERSPACE, SPROTTE SPINAL NEEDLE WAS ADVANCED, BONE FELT, SPINAL NEEDLE WITHDRAWN INTO INTRODUCER NEEDLE, REPOSITIONED, SPINAL NEEDLE WAS ADVANCED, STYLET REMOVED, BLOOD RETURN, BOTH NEEDLES WERE REMOVED, SPINAL NEEDLE STRAIGHT INTACT. INTRODUCER WAS THEN POSITIONED L3-4 INTERSPACE, NEW SPROTTEE SPINAL NEEDLE ADVANCED, BONE FELT, SPINAL NEEDLE WITHDRAWN INTO INTRODUCER NEEDLE, REPOSITIONED NEEDLES, SPINAL NEEDLE ADVANCE, STYLET REMOVED, CLEAR SPINAL FLUID OBSERVED COMING FROM HUB OF SPINAL NEEDLE, SYRINGE WITH ANESTHETIC ATTACHED TO SPINAL NEEDLE, ASPIRATED NEEDLE ROTATED (NO RESISTENCE FELT), ONLY A PORTION OF SPINAL NEEDLE REMOVED, X-RAY PATIENT SPINE DEMONSTRATED REMAINING PORTION OF SPINAL NEEDLE, PATIENT WAS LATER TRANSFERRED TO MARSHFIELD HOSPITAL WHERE BROKEN OFF PORTION OF SPINAL NEEDLE WAS REMOVED 8/11/92. NO ADVERSE SEQUELA TO PATIENT AS OF AUGUST 14, 1992 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: A DEVICE FROM SAME LOT WAS EVALUATED, VISUAL EXAMINATION. RESULTS OF EVALUATION: COMPONENT FAILURE, TELEMETRY FAILURE, NONE OR UNKNOWN, NONE OR UNKNOWN. CONCLUSION: INVALID DATA. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: YES. CORRECTIVE ACTIONS: NONE OR UNKNOWN. THE DEVICE WAS NOT DESTROYED/DISPOSED OF. |