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)

B. BRAUN MEDICAL, INC.

901 MARCON BLVD.

ALLENTOWN PA 18103

 

MANUFACTURER (Section D)

B. BRAUN MEDICAL, INC.

901 MARCON BLVD.

ALLENTOWN PA 18103

 

MANUFACTURER CONTACT

ART MORSE

901 MARCON BLVD

ALLENTOWN , PA 18103

(610) 266 -0500

 

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)

B. BRAUN MEDICAL, INC.

901 MARCON BLVD.

ALLENTOWN PA 18103

 

MANUFACTURER (Section D)

B. BRAUN MEDICAL, INC.

901 MARCON BLVD.

ALLENTOWN PA 18103

 

MANUFACTURER CONTACT

ART MORSE

901 MARCON BLVD

ALLENTOWN , PA 18103

(610) 266 -0500

 

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)

B. BRAUN MEDICAL, INC.

901 MARCON BLVD.

ALLENTOWN PA 18103

 

MANUFACTURER (Section D)

B. BRAUN MEDICAL, INC.

901 MARCON BLVD.

ALLENTOWN PA 18103

 

MANUFACTURER CONTACT

ART MORSE

901 MARCON BLVD

ALLENTOWN , PA 18103

(610) 266 -0500

 

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)

B BRAUN MEDICAL, INC

901 MARCON BLVD

ALLENTOWN PA 18103

 

MANUFACTURER (Section D)

B BRAUN MEDICAL, INC

901 MARCON BLVD

ALLENTOWN PA 18103

 

MANUFACTURER CONTACT

ART MORSE

901 MARCON BLVD

ALLENTOWN , PA 18103

(610) 266 -0500

 

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)

B. BRAUN MEDICAL, INC.

901 MARCON BLVD.

ALLENTOWN PA 18103

 

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)

B. BRAUN MEDICAL, INC.

901 MARCON BLVD.

ALLENTOWN PA 18103

 

MANUFACTURER (Section D)

B. BRAUN MEDICAL, INC.

901 MARCON BLVD.

ALLENTOWN PA 18103

 

MANUFACTURER CONTACT

ART MORSE

901 MARCON BLVD

ALLENTOWN , PA 18103

(610) 266 -0500

 

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)

B. BRAUN MEDICAL, INC.

901 MARCON BLVD.

ALLENTOWN PA 18103

 

MANUFACTURER (Section D)

B. BRAUN MEDICAL, INC.

901 MARCON BLVD.

ALLENTOWN PA 18103

 

MANUFACTURER CONTACT

ART MORSE

901 MARCON BLVD

ALLENTOWN , PA 18103

(610) 266 -0500

 

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)

B. BRAUN MEDICAL, INC.

901 MARCON BLVD.

ALLENTOWN PA 18103

 

MANUFACTURER (Section D)

B. BRAUN MEDICAL, INC.

901 MARCON BLVD.

ALLENTOWN PA 18103

 

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)

B. BRAUN MEDICAL, INC.

901 MARCON BLVD.

ALLENTOWN PA 18103

 

MANUFACTURER (Section D)

B. BRAUN MEDICAL, INC.

901 MARCON BLVD.

ALLENTOWN PA 18103

 

MANUFACTURER CONTACT

ART MORSE

901 MARCON BLVD.

ALLENTOWN , PA 18103

(610) 266 -0500

 

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)

B. BRAUN MEDICAL, INC.

901 MARCON BLVD.

ALLENTOWN PA 18103

 

MANUFACTURER (Section D)

B. BRAUN MEDICAL, INC.

901 MARCON BLVD.

ALLENTOWN PA 18103

 

MANUFACTURER CONTACT

KIKOO TEJWANI

901 MARCON BLVD.

ALLENTOWN , PA 18103

(610) 266 -0500

 

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)

B. BRAUN MEDICAL, INC.

901 MARCON BLVD.

ALLENTOWN PA 18103

 

MANUFACTURER (Section D)

B. BRAUN MEDICAL, INC.

901 MARCON BLVD.

ALLENTOWN PA 18103

 

MANUFACTURER CONTACT

KIKOO TEJWANI

901 MARCON BLVD.

ALLENTOWN , PA 18103

(610) 266 -0500

 

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)

B. BRAUN MEDICAL, INC.

901 MARCON BLVD.

ALLENTOWN PA 18103

 

MANUFACTURER (Section D)

B. BRAUN MEDICAL, INC.

901 MARCON BLVD.

ALLENTOWN PA 18103

 

MANUFACTURER CONTACT

ANDREW HARAKAL

901 MARCON BLVD.

ALLENTOWN , PA 18103

(610) 266 -0500

 

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)

B. BRAUN MEDICAL, INC.

901 MARCON BLVD.

ALLENTOWN PA 18103

 

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)

B. BRAUN MEDICAL, INC.

901 MARCON BLVD.

ALLENTOWN PA 18103

 

MANUFACTURER (Section D)

B. BRAUN MEDICAL, INC.

901 MARCON BLVD.

ALLENTOWN PA 18103

 

MANUFACTURER CONTACT

ANDREW HARAKAL

901 MARCON BLVD.

ALLENTOWN , PA 18103

(610) 266 -0500

 

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)

B. BRAUN MEDICAL INC.

P.O. BOX 95830

CHICAGO IL *

 

MANUFACTURER (Section D)

B. BRAUN MEDICAL INC.

P.O. BOX 95830

CHICAGO IL *

 

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.

BRAND NAME

PERIFIX

TYPE OF DEVICE

CONTINUOUS EPIDURAL

BASELINE BRAND NAME

PERIFIX

BASELINE GENERIC NAME

PERIFIX CONTINUOUS EPIDURAL TRAY

BASELINE CATALOGUE NUMBER

332202

BASELINE MODEL NUMBER

CE-17T

MANUFACTURER (Section F)

B. BRAUN MEDICAL, INC.

901 MARCON BLVD.

ALLENTOWN PA 18103

 

MANUFACTURER (Section D)

B. BRAUN MEDICAL, INC.

901 MARCON BLVD.

ALLENTOWN PA 18103

 

MANUFACTURER CONTACT

ANDREW HARAKAL

901 MARCON BLVD

ALLENTOWN , PA 18103

(610) 266 -0500

 

DEVICE EVENT KEY

338135

MDR REPORT KEY

348810

EVENT KEY

328532

REPORT NUMBER

2523676-2001-00040

DEVICE SEQUENCE NUMBER

1

PRODUCT CODE

BSO

REPORT SOURCE

MANUFACTURER

SOURCE TYPE

HEALTH PROFESSIONAL

REMEDIAL ACTION

OTHER

EVENT TYPE

INJURY

TYPE OF REPORT

INITIAL

REPORT DATE

08/10/2001

1 DEVICE WAS INVOLVED IN THE EVENT

 

1 PATIENT WAS INVOLVED IN THE EVENT

 

DATE FDA RECEIVED

08/23/2001

IS THIS AN ADVERSE EVENT REPORT?

YES

IS THIS A PRODUCT PROBLEM REPORT?

NO

DEVICE OPERATOR

HEALTH PROFESSIONAL

DEVICE EXPIRATION DATE

04/30/2006

DEVICE MODEL NUMBER

CE-17T

DEVICE CATALOGUE NUMBER

332202

DEVICE LOT NUMBER

60208970

WAS DEVICE AVAILABLE FOR EVALUATION?

NO

IS THE REPORTER A HEALTH PROFESSIONAL?

YES

WAS THE REPORT SENT TO FDA?

NO

DISTRIBUTOR FACILITY AWARE DATE

07/26/2001

DEVICE AGE

3 MO

EVENT LOCATION

HOSPITAL

DATE MANUFACTURER RECEIVED

08/01/2001

WAS DEVICE EVALUATED BY MANUFACTURER?

DEVICE NOT RETURNED TO MANUFACTURER

DATE DEVICE MANUFACTURED

04/01/2001

IS THE DEVICE SINGLE USE?

YES

TYPE OF DEVICE USAGE

UNKNOWN

PATIENT OUTCOME

REQUIRED INTERVENTION 

 

ADVERSE EVENT OR PRODUCT PROBLEM DESCRIPTION

REPORT DATE: 08/10/2001  MDR TEXT KEY: 1209894 Patient Sequence Number: 1

PHYSICIAN REPORTED RESISTANCE WAS MET BY NURSE UPON REMOVAL OF CATHETER. CATHETER WAS STRETCHED, BREAKING OFF APPROX 1CM, AND REMAINS IN PT'S BACK. NEUROSURGEON CONSULTED AND CAT SCAN COMPLETED.

 

ADDITIONAL MANUFACTURER NARRATIVE

REPORT DATE: 08/23/2001  MDR TEXT KEY: 1209897 

THE SAMPLE IS CURRENTLY BEING RETAINED BY THE HOSP'S RISK MGMT DEPT, AND IS NOT AVAILABLE AT THIS TIME. A FOLLOW-UP REPORT WILL BE SUBMITTED IF ADD'L INFO BECOMES AVAILABLE. NO FURTHER INFO IS AVAILABLE ON THE PT'S STATUS. NO DEFINITE CONCLUSION CAN BE DRAWN, SINCE THE ACTUAL SAMPLE COULD NOT BE EVALUATED. IT SHOULD BE NOTED THAT THE LABELING ON THE TRAY STATES, "DO NOT WITHDRAW CATHETER THROUGH THE NEEDLE BECAUSE OF POSSIBLE DANGER OF SHEARING".

 

 

 

 

 

 

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)

B. BRAUN MEDICAL, INC.

901 MARCON BLVD.

ALLENTOWN PA 18109

 

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)

B. BRAUN MEDICAL, INC.

901 MARCON BLVD.

ALLENTOWN PA 18109

 

MANUFACTURER (Section D)

B. BRAUN MEDICAL, INC.

901 MARCON BLVD.

ALLENTOWN PA 18109

 

MANUFACTURER CONTACT

ANDREW HARAKAL

901 MARCON BLVD.

ALLENTOWN , PA 18103

(610) 266 -0500

 

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)

B. BRAUN MEDICAL, INC.

901 MARCON BLVD.

ALLENTOWN PA 18103

 

MANUFACTURER (Section D)

B. BRAUN MEDICAL, INC.

901 MARCON BLVD.

ALLENTOWN PA 18103

 

MANUFACTURER CONTACT

ANDREW HARAKAL

901 MARCON BLVD.

ALLENTOWN , PA 18103

(610) 266 -0500

 

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)

B. BRAUN MEDICAL, INC.

901 MARCON BLVD.

ALLENTOWN PA 18103

 

MANUFACTURER (Section D)

B. BRAUN MEDICAL, INC.

901 MARCON BLVD.

ALLENTOWN PA 18103

 

MANUFACTURER CONTACT

ANDREW HARAKAL

901 MARCON BLVD.

ALLENTOWN , PA 18103

(610) 266 -0500

 

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)

B. BRAUN MEDICAL, INC.

901 MARCON BLVD.

ALLENTOWN PA 18103

 

MANUFACTURER (Section D)

B. BRAUN MEDICAL, INC.

901 MARCON BLVD.

ALLENTOWN PA 18103

 

MANUFACTURER CONTACT

ANDREW HARAKAL

901 MARCON BLVD.

ALLENTOWN , PA 18103

(610) 266 -0500

 

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)

B.BRAUN MEDICAL INC.

2525 MCGAW AVE

PO BOX 19791

IRVINE CA 92623

 

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)

B. BRAUN MEDICAL, INC.

901 MARCON BLVD.

ALLENTOWN PA 18103

 

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)

B. BRAUN MEDICAL, INC.

901 MARCON BLVD.

ALLENTOWN PA 18103

 

MANUFACTURER (Section D)

B. BRAUN MEDICAL, INC.

901 MARCON BLVD.

ALLENTOWN PA 18103

 

MANUFACTURER CONTACT

ANDREW HARAKAL

901 MARCON BLVD.

ALLENTOWN , PA 18103

(610) 266 -0500

 

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)

B. BRAUN MEDICAL, INC.

901 MARCON BLVD.

ALLENTOWN PA 18103

 

MANUFACTURER (Section D)

B. BRAUN MEDICAL, INC.

901 MARCON BLVD.

ALLENTOWN PA 18103

 

MANUFACTURER CONTACT

ANDREW HARAKAL

901 MARCON BLVD.

ALLENTOWN , PA 18103

(610) 266 -0500

 

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)

B.BRAUN MEDICAL, INC.

824 12TH AVE

BETHLEHEM PA 18018

 

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)

B. BRAUN MEDICAL, INC.

901 MARCON BLVD.

ALLENTOWN PA 18103

 

MANUFACTURER (Section D)

B. BRAUN MEDICAL, INC.

901 MARCON BLVD.

ALLENTOWN PA 18103

 

MANUFACTURER CONTACT

ANDREW HARAKAL

901 MARCON BLVD.

ALLENTOWN , PA 18103

(610) 266 -0500

 

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)

B. BRAUN MEDICAL, INC.

901 MARCON BLVD.

ALLENTOWN PA 18103

 

MANUFACTURER (Section D)

B. BRAUN MEDICAL, INC.

901 MARCON BLVD.

ALLENTOWN PA 18103

 

MANUFACTURER CONTACT

ANDREW HARAKAL

901 MARCON BLVD.

ALLENTOWN , PA 18103

(610) 266 -0500

 

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)

B. BRAUN MEDICAL, INC.

901 MARCON BLVD.

ALLENTOWN PA 18103

 

MANUFACTURER (Section D)

B. BRAUN MEDICAL, INC.

901 MARCON BLVD.

ALLENTOWN PA 18103

 

MANUFACTURER CONTACT

ANDREW HARAKAL

901 MARCON BLVD.

ALLENTOWN , PA 18103

(610) 266 -0500

 

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)

B BRAUN MEDICAL INC

BETHLEHAM PA 18018

 

MANUFACTURER (Section D)

B BRAUN MEDICAL INC

BETHLEHAM PA 18018

 

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)

B. BRAUN MEDICAL, INC.

901 MARCON BLVD.

ALLENTOWN PA 18103

 

MANUFACTURER (Section D)

B. BRAUN MEDICAL, INC.

901 MARCON BLVD.

ALLENTOWN PA 18103

 

MANUFACTURER CONTACT

ANDREW HARAKAL

901 MARCON BLVD.

ALLENTOWN , PA 18103

(610) 266 -0500

 

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)

B. BRAUN MEDICAL, INC.

901 MARCON BLVD.

ALLENTOWN PA 18103

 

MANUFACTURER (Section D)

B. BRAUN MEDICAL, INC.

901 MARCON BLVD.

ALLENTOWN PA 18103

 

MANUFACTURER CONTACT

ANDREW HARAKAL

901 MARCON BLVD.

ALLENTOWN , PA 18103

(610) 266 -0500

 

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)

B. BRAUN MEDICAL, INC.

901 MARCON BLVD.

ALLENTOWN PA 18103

 

MANUFACTURER (Section D)

B. BRAUN MEDICAL, INC.

901 MARCON BLVD.

ALLENTOWN PA 18103

 

MANUFACTURER CONTACT

ANDREW HARAKAL

901 MARCON BLVD.

ALLENTOWN , PA 18103

(610) 266 -0500

 

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)

B. BRAUN MEDICAL, INC.

901 MARCON BLVD.

ALLENTOWN PA 18103

 

MANUFACTURER (Section D)

B. BRAUN MEDICAL, INC.

901 MARCON BLVD.

ALLENTOWN PA 18103

 

MANUFACTURER CONTACT

ANDREW HARAKAL

901 MARCON BLVD.

ALLENTOWN , PA 18103

(610) 266 -0500

 

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)

B. BRAUN MEDICAL, INC.

901 MARCON BLVD.

ALLENTOWN PA 18103

 

MANUFACTURER (Section D)

B. BRAUN MEDICAL, INC.

901 MARCON BLVD.

ALLENTOWN PA 18103

 

MANUFACTURER CONTACT

ANDREW HARAKAL

901 MARCON BLVD.

ALLENTOWN , PA 18103

(610) 266 -0500

 

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)

B. BRAUN MEDICAL, INC.

901 MARCON BLVD.

ALLENTOWN PA 18103

 

MANUFACTURER (Section D)

B. BRAUN MEDICAL, INC.

901 MARCON BLVD.

ALLENTOWN PA 18103

 

MANUFACTURER CONTACT

ANDREW HARAKAL

901 MARCON BLVD.

ALLENTOWN , PA 18103

(610) 266 -0500

 

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)

B. BRAUN MEDICAL, INC.

901 MARCON BLVD.

ALLENTOWN PA 18103

 

MANUFACTURER (Section D)

B. BRAUN MEDICAL, INC.

901 MARCON BLVD.

ALLENTOWN PA 18103

 

MANUFACTURER CONTACT

ANDREW HARAKAL

901 MARCON BLVD.

ALLENTOWN , PA 18103

(610) 266 -0500

 

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)

B. BRAUN MEDICAL, INC.

901 MARCON BLVD.

ALLENTOWN PA 18103

 

MANUFACTURER (Section D)

B. BRAUN MEDICAL, INC.

901 MARCON BLVD.

ALLENTOWN PA 18103

 

MANUFACTURER CONTACT

ANDREW HARAKAL

901 MARCON BLVD.

ALLENTOWN , PA 18103

(610) 266 -0500

 

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)

B. BRAUN MEDICAL, INC.

901 MARCON BLVD.

ALLENTOWN PA 18103

 

MANUFACTURER (Section D)

B. BRAUN MEDICAL, INC.

901 MARCON BLVD.

ALLENTOWN PA 18103

 

MANUFACTURER CONTACT

ANDREW HARAKAL

901 MARCON BLVD.

ALLENTOWN , PA 18103

(610) 266 -0500

 

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)

B. BRAUN MEDICAL, INC.

901 MARCON BLVD.

ALLENTOWN PA 18103

 

MANUFACTURER (Section D)

B. BRAUN MEDICAL, INC.

901 MARCON BLVD.

ALLENTOWN PA 18103

 

MANUFACTURER CONTACT

ANDREW HARAKAL

901 MARCON BLVD.

ALLENTOWN , PA 18103

(610) 266 -0500

 

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)

B. BRAUN MEDICAL, INC.

901 MARCON BLVD.

ALLENTOWN PA 18103

 

MANUFACTURER (Section D)

B. BRAUN MEDICAL, INC.

901 MARCON BLVD.

ALLENTOWN PA 18103

 

MANUFACTURER CONTACT

ANDREW HARAKAL

901 MARCON BLVD.

ALLENTOWN , PA 18103

(610) 266 -0500

 

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)

B. BRAUN MEDICAL, INC.

901 MARCON BLVD.

ALLENTOWN PA 18103

 

MANUFACTURER (Section D)

B. BRAUN MEDICAL, INC.

901 MARCON BLVD.

ALLENTOWN PA 18103

 

MANUFACTURER CONTACT

ANDREW HARAKAL

901 MARCON BLVD.

ALLENTOWN , PA 18103

(610) 266 -0500

 

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)

B. BRAUN MEDICAL, INC.

901 MARCON BLVD.

ALLENTOWN PA 18103

 

MANUFACTURER (Section D)

B. BRAUN MEDICAL, INC.

901 MARCON BLVD.

ALLENTOWN PA 18103

 

MANUFACTURER CONTACT

ANDREW HARAKAL

901 MARCON BLVD.

ALLENTOWN , PA 18103

(610) 266 -0500

 

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)

B. BRAUN MEDICAL, INC.

901 MARCON BLVD.

ALLENTOWN PA 18103

 

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)

B. BRAUN MEDICAL INC.

P.O. BOX 8500 S-2386

PHILADELPHIA PA 19178

 

MANUFACTURER (Section D)

B. BRAUN MEDICAL INC.

P.O. BOX 8500 S-2386

PHILADELPHIA PA 19178

 

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)

B. BRAUN MEDICAL, INC.

901 MARCON BLVD.

ALLENTOWN PA 18103

 

MANUFACTURER (Section D)

B. BRAUN MEDICAL, INC.

901 MARCON BLVD.

ALLENTOWN PA 18103

 

MANUFACTURER CONTACT

ANDREW HARAKAL

901 MARCON BLVD.

ALLENTOWN , PA 18103

(610) 266 -0500

 

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)

B. BRAUN MEDICAL, INC.

824 TWELFTH AVE.

BETHLEHEM PA 18018

 

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)

B. BRAUN MEDICAL, INC.

901 MARCON BLVD.

ALLENTOWN PA 18103

 

MANUFACTURER (Section D)

B. BRAUN MEDICAL, INC.

901 MARCON BLVD.

ALLENTOWN PA 18103

 

MANUFACTURER CONTACT

ANDREW HARAKAL

901 MARCON BLVD.

ALLENTOWN , PA 18103

(610) 266 -0500

 

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)

B. BRAUN MEDICAL, INC.

901 MARCON BLVD.

ALLENTOWN PA 18103

 

MANUFACTURER (Section D)

B. BRAUN MEDICAL, INC.

901 MARCON BLVD.

ALLENTOWN PA 18103

 

MANUFACTURER CONTACT

ANDREW HARAKAL

901 MARCON BLVD.

ALLENTOWN , PA 18103

(610) 266 -0500

 

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)

B. BRAUN MEDICAL, INC.

901 MARCON BLVD.

ALLENTOWN PA 18103

 

MANUFACTURER (Section D)

B. BRAUN MEDICAL, INC.

901 MARCON BLVD.

ALLENTOWN PA 18103

 

MANUFACTURER CONTACT

ANDREW HARAKAL

901 MARCON BLVD.

ALLENTOWN , PA 18103

(610) 266 -0500

 

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)

B. BRAUN MEDICAL, INC.

901 MARCON BLVD.

ALLENTOWN PA 18103

 

MANUFACTURER (Section D)

B. BRAUN MEDICAL, INC.

901 MARCON BLVD.

ALLENTOWN PA 18103

 

MANUFACTURER CONTACT

ANDREW HARAKAL

901 MARCON BLVD.

ALLENTOWN , PA 18103

(610) 266 -0500

 

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)

B. BRAUN MEDICAL, INC.

901 MARCON BLVD.

ALLENTOWN PA 18103

 

MANUFACTURER (Section D)

B. BRAUN MEDICAL, INC.

901 MARCON BLVD.

ALLENTOWN PA 18103

 

MANUFACTURER CONTACT

ANDREW HARAKAL

901 MARCON BLVD.

ALLENTOWN , PA 18103

(610) 266 -0500

 

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)

B. BRAUN MEDICAL, INC.

824 12TH AVE.

BETHLEHEM PA 18018

 

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)

B. BRAUN MEDICAL, INC.

901 MARCON BLVD.

ALLENTOWN PA 18103

 

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)

B. BRAUN MEDICAL, INC.

901 MARCON BLVD.

ALLENTOWN PA 18103

 

MANUFACTURER (Section D)

B. BRAUN MEDICAL, INC.

901 MARCON BLVD.

ALLENTOWN PA 18103

 

MANUFACTURER CONTACT

ANDREW HARAKAL

901 MARCON BLVD.

ALLENTOWN , PA 18103

(610) 266 -0500

 

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)

B. BRAUN MEDICAL, INC.

901 MARCON BLVD.

ALLENTOWN PA 18103

 

MANUFACTURER (Section D)

B. BRAUN MEDICAL, INC.

901 MARCON BLVD.

ALLENTOWN PA 18103

 

MANUFACTURER (Section G)

B. BRAUN MEDICAL, INC.

901 MARCON BLVD.

 

ALLENTOWN PA 18109

 

MANUFACTURER CONTACT

ANDREW HARAKAL

901 MARCON BLVD

ALLENTOWN , PA 18103

(610) 266 -0500 ext 2334

 

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)

B. BRAUN MEDICAL, INC.

901 MARCON BLVD.

ALLENTOWN PA 18103

 

MANUFACTURER (Section D)

B. BRAUN MEDICAL, INC.

901 MARCON BLVD.

ALLENTOWN PA 18103

 

MANUFACTURER (Section G)

B. BRAUN MEDICAL, INC.

901 MARCON BLVD.

 

ALLENTOWN PA 18109

 

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)

B. BRAUN MEDICAL, INC.

901 MARCON BLVD.

ALLENTOWN PA 18103

 

MANUFACTURER (Section D)

B. BRAUN MEDICAL, INC.

901 MARCON BLVD.

ALLENTOWN PA 18103

 

MANUFACTURER (Section G)

B. BRAUN MEDICAL, INC.

901 MARCON BLVD.

 

ALLENTOWN PA 18109

 

MANUFACTURER CONTACT

ANDREW HARAKAL

901 MARCON BLVD.

ALLENTOWN , PA 18103

(610) 266 -0500 ext 2334

 

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