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.

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.

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.

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.

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.

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".

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.

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.

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."

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".

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."

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".

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".

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.

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.

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.

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".

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.

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".

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".

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.

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."

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.