BRAND NAME

PERIFIX

TYPE OF DEVICE

PERIFIX CONTINUOUS EPIDURAL TRAYS

BASELINE BRAND NAME

PERIFIX

BASELINE GENERIC NAME

CONTINUOUS EPIDURAL TRAY

BASELINE CATALOGUE NUMBER

332229

BASELINE MODEL NUMBER

CE17TKCD

BASELINE DEVICE FAMILY

CONTINUOUS EPIDURAL KIT

BASELINE DEVICE 510(K) NUMBER

K840179

BASELINE SHELF LIFE INFORMATION

YES

IS BASELINE PMA NUMBER PROVIDED?</< TH>

NO

BASELINE PREAMENDMENT?

NO

TRANSITIONAL?

NO

510(K) EXEMPT?

NO

SHELF LIFE(Months)

12

DATE FIRST MARKETED

02/24/1984

MANUFACTURER (Section F)

MANUFACTURER (Section D)

MANUFACTURER CONTACT

DEVICE EVENT KEY

422769

MDR REPORT KEY

433826

EVENT KEY

410502

REPORT NUMBER

2523676-2002-00071

DEVICE SEQUENCE NUMBER

1

PRODUCT CODE

CAZ

REPORT SOURCE

MANUFACTURER

SOURCE TYPE

USER FACILITY

REMEDIAL ACTION

OTHER

EVENT TYPE

INJURY

TYPE OF REPORT

INITIAL

REPORT DATE

12/09/2002

1 DEVICE WAS INVOLVED IN THE EVENT

1 PATIENT WAS INVOLVED IN THE EVENT

DATE FDA RECEIVED

12/16/2002

IS THIS AN ADVERSE EVENT REPORT?

YES

IS THIS A PRODUCT PROBLEM REPORT?

NO

DEVICE OPERATOR

HEALTH PROFESSIONAL

DEVICE MODEL NUMBER

CE17TKCD

DEVICE CATALOGUE NUMBER

332212

WAS DEVICE AVAILABLE FOR EVALUATION?

NO

IS THE REPORTER A HEALTH PROFESSIONAL?

YES

WAS THE REPORT SENT TO FDA?

NO

DISTRIBUTOR FACILITY AWARE DATE

11/06/2002

DEVICE AGE

UNKNOWN

EVENT LOCATION

HOSPITAL

DATE MANUFACTURER RECEIVED

11/20/2002

WAS DEVICE EVALUATED BY MANUFACTURER?

DEVICE NOT RETURNED TO MANUFACTURER

IS THE DEVICE SINGLE USE?

YES

TYPE OF DEVICE USAGE

UNKNOWN

PATIENT OUTCOME

OTHER 

ADVERSE EVENT OR PRODUCT PROBLEM DESCRIPTION

REPORT DATE: 12/09/2002  MDR TEXT KEY: 1505753 Patient Sequence Number: 1

EVENT AS REPORTED BY THE USER FACILITY: "DURING REMOVAL OF EPIDURAL CATHETER, PORTION OF CATHETER STAYED IN PT. VERIFIED BY XRAY."

ADDITIONAL MANUFACTURER NARRATIVE

REPORT DATE: 12/09/2002  MDR TEXT KEY: 1505756 

THE ACTUAL SAMPLE IS NOT AVAILABLE FOR THE MFR TO EVALUATE. WITHOUT THE SAMPLE, A COMPLETE EVALUATION COULD NOT BE PERFORMED. BASED ON THE INFO PROVIDED, NO SPECIFIC CONCLUSIONS CAN BE DRAWN.

BRAND NAME

PERIFIX

TYPE OF DEVICE

CONTINUOUS EPIDURAL KIT

BASELINE BRAND NAME

PERIFIX

BASELINE GENERIC NAME

CONTINUOUS EPIDURAL TRAY

BASELINE CATALOGUE NUMBER

332086

BASELINE MODEL NUMBER

CE17TKF

BASELINE DEVICE FAMILY

CONTINUOUS EPIDURAL KIT

BASELINE DEVICE 510(K) NUMBER

K840179

BASELINE SHELF LIFE INFORMATION

YES

IS BASELINE PMA NUMBER PROVIDED?</< TH>

NO

BASELINE PREAMENDMENT?

NO

TRANSITIONAL?

NO

510(K) EXEMPT?

NO

SHELF LIFE(Months)

12

DATE FIRST MARKETED

02/24/1984

MANUFACTURER (Section F)

MANUFACTURER (Section D)

MANUFACTURER CONTACT

DEVICE EVENT KEY

418446

MDR REPORT KEY

429440

EVENT KEY

406258

REPORT NUMBER

2523676-2002-00064

DEVICE SEQUENCE NUMBER

1

PRODUCT CODE

CAZ

REPORT SOURCE

MANUFACTURER

SOURCE TYPE

USER FACILITY

REMEDIAL ACTION

OTHER

EVENT TYPE

INJURY

TYPE OF REPORT

INITIAL

REPORT DATE

11/14/2002

1 DEVICE WAS INVOLVED IN THE EVENT

1 PATIENT WAS INVOLVED IN THE EVENT

DATE FDA RECEIVED

11/22/2002

IS THIS AN ADVERSE EVENT REPORT?

YES

IS THIS A PRODUCT PROBLEM REPORT?

NO

DEVICE OPERATOR

HEALTH PROFESSIONAL

DEVICE EXPIRATION DATE

04/30/2003

DEVICE MODEL NUMBER

CE17TKF

DEVICE CATALOGUE NUMBER

332086

DEVICE LOT NUMBER

60317566

WAS DEVICE AVAILABLE FOR EVALUATION?

YES

DATE RETURNED TO MANUFACTURER

11/05/2002

IS THE REPORTER A HEALTH PROFESSIONAL?

YES

WAS THE REPORT SENT TO FDA?

NO

DISTRIBUTOR FACILITY AWARE DATE

10/16/2002

DEVICE AGE

UNKNOWN

EVENT LOCATION

HOSPITAL

DATE MANUFACTURER RECEIVED

10/24/2002

WAS DEVICE EVALUATED BY MANUFACTURER?

YES

IS THE DEVICE SINGLE USE?

YES

TYPE OF DEVICE USAGE

UNKNOWN

PATIENT OUTCOME

OTHER 

ADVERSE EVENT OR PRODUCT PROBLEM DESCRIPTION

REPORT DATE: 11/14/2002  MDR TEXT KEY: 1490435 Patient Sequence Number: 1

WHEN PLASTIC STYLET WAS REMOVED FROM EPIDURAL NEEDLE, THE TIP OF THE STYLET SHEARED OFF AND REMAINED IN PATIENT.

ADDITIONAL MANUFACTURER NARRATIVE

REPORT DATE: 11/14/2002  MDR TEXT KEY: 1490438 

ONE USED TUOHY NEEDLE WAS RETURNED FOR EVVALUATION. THE STYLET APPEARS TO HAVE BEEN CUT TO THE APPROPRIATE LENGTH DURING ITS MANUFACTURING, HOWEVER, THE TIP OF THE STYLET'S BEVEL IS STRETCHED. BASED ON THE INFORMATION PROVIDED, NO SPECIFIC CONCLUSION CAN BE DRAWN. IF APPROPRIATE, A FOLLOW-UP REPORT WILL BE FILED WHEN ADDITIONAL INFORMATION PERTAINING TO THIS INCIDENT IS RECEIVED.

BRAND NAME

PERIFIX

TYPE OF DEVICE

CONTINUOUS EPIDURAL TRAY

BASELINE BRAND NAME

PERIFIX

BASELINE GENERIC NAME

CONTINUOUS EPIDURAL TRAY

BASELINE CATALOGUE NUMBER

332229

BASELINE MODEL NUMBER

CE17TKCD

BASELINE DEVICE FAMILY

CONTINUOUS EPIDURAL KIT

BASELINE DEVICE 510(K) NUMBER

K840179

BASELINE SHELF LIFE INFORMATION

YES

IS BASELINE PMA NUMBER PROVIDED?</< TH>

NO

BASELINE PREAMENDMENT?

NO

TRANSITIONAL?

NO

510(K) EXEMPT?

NO

SHELF LIFE(Months)

12

DATE FIRST MARKETED

02/24/1984

MANUFACTURER (Section F)

MANUFACTURER (Section D)

MANUFACTURER CONTACT

DEVICE EVENT KEY

412070

MDR REPORT KEY

423016

EVENT KEY

400109

REPORT NUMBER

2523676-2002-00060

DEVICE SEQUENCE NUMBER

1

PRODUCT CODE

CAZ

REPORT SOURCE

MANUFACTURER

SOURCE TYPE

USER FACILITY

REMEDIAL ACTION

OTHER

EVENT TYPE

INJURY

TYPE OF REPORT

INITIAL

REPORT DATE

10/07/2002

1 DEVICE WAS INVOLVED IN THE EVENT

1 PATIENT WAS INVOLVED IN THE EVENT

DATE FDA RECEIVED

10/15/2002

IS THIS AN ADVERSE EVENT REPORT?

YES

IS THIS A PRODUCT PROBLEM REPORT?

NO

DEVICE OPERATOR

HEALTH PROFESSIONAL

DEVICE EXPIRATION DATE

03/30/2004

DEVICE MODEL NUMBER

CE17TKCD

DEVICE CATALOGUE NUMBER

332229

DEVICE LOT NUMBER

60352183

WAS DEVICE AVAILABLE FOR EVALUATION?

NO

IS THE REPORTER A HEALTH PROFESSIONAL?

YES

WAS THE REPORT SENT TO FDA?

NO

DISTRIBUTOR FACILITY AWARE DATE

09/11/2002

DEVICE AGE

UNKNOWN

EVENT LOCATION

HOSPITAL

DATE MANUFACTURER RECEIVED

09/13/2002

WAS DEVICE EVALUATED BY MANUFACTURER?

DEVICE NOT RETURNED TO MANUFACTURER

IS THE DEVICE SINGLE USE?

YES

TYPE OF DEVICE USAGE

UNKNOWN

PATIENT OUTCOME

OTHER 

ADVERSE EVENT OR PRODUCT PROBLEM DESCRIPTION

REPORT DATE: 10/07/2002  MDR TEXT KEY: 1468141 Patient Sequence Number: 1

DOCTOR MET RESISTANCE UPON REMOVING EPIDURAL CATHETER, CONTINUED TO PULL. UPON REMOVAL, FOUND TIP OF CATHETER MISSING (APPROX 1 CM). PT IN FOR BOWEL CANCER. UNABLE TO SEE CATHETER ON X-RAY.

ADDITIONAL MANUFACTURER NARRATIVE

REPORT DATE: 10/07/2002  MDR TEXT KEY: 1468144 

THE ACTUAL SAMPLE IS NOT AVAILABLE FOR THE MFR'S EVAL. BASED ON THE INFO PROVIDED NO SPECIFIC CONCLUSIONS CAN BE DRAWN. HOWEVER, IT APPEARS THAT THE CATHETER BECAME LODGED IN BETWEEN TWO RIGID BODY STRUCTURES AND WAS PULLED BEYONG ITS DESIGN CAPABILITIES.

BRAND NAME

PERIFIX

TYPE OF DEVICE

CONTINUOUS EPIDURAL TRAY

BASELINE BRAND NAME

PERIFIX

BASELINE GENERIC NAME

CONTINUOUS EPIDURAL TRAY

BASELINE CATALOGUE NUMBER

332220

BASELINE MODEL NUMBER

CE18TK

BASELINE DEVICE FAMILY

CONTINUOUS EPIDURAL KIT

BASELINE DEVICE 510(K) NUMBER

K840179

BASELINE SHELF LIFE INFORMATION

YES

IS BASELINE PMA NUMBER PROVIDED?</< TH>

NO

BASELINE PREAMENDMENT?

NO

TRANSITIONAL?

NO

510(K) EXEMPT?

NO

SHELF LIFE(Months)

12

DATE FIRST MARKETED

02/24/1984

MANUFACTURER (Section F)

MANUFACTURER (Section D)

MANUFACTURER CONTACT

DEVICE EVENT KEY

403077

MDR REPORT KEY

414038

EVENT KEY

385346

REPORT NUMBER

2523676-2002-00050

DEVICE SEQUENCE NUMBER

1

PRODUCT CODE

CAZ

REPORT SOURCE

MANUFACTURER

SOURCE TYPE

USER FACILITY

REMEDIAL ACTION

OTHER

EVENT TYPE

INJURY

TYPE OF REPORT

INITIAL

REPORT DATE

08/27/2002

1 DEVICE WAS INVOLVED IN THE EVENT

1 PATIENT WAS INVOLVED IN THE EVENT

DATE FDA RECEIVED

08/30/2002

IS THIS AN ADVERSE EVENT REPORT?

YES

IS THIS A PRODUCT PROBLEM REPORT?

NO

DEVICE MODEL NUMBER

CE18TK

DEVICE CATALOGUE NUMBER

332220

WAS THE REPORT SENT TO FDA?

NO

DEVICE AGE

UNKNOWN

DATE MANUFACTURER RECEIVED

07/31/2002

WAS DEVICE EVALUATED BY MANUFACTURER?

DEVICE NOT RETURNED TO MANUFACTURER

IS THE DEVICE SINGLE USE?

YES

TYPE OF DEVICE USAGE

UNKNOWN

ADDITIONAL MANUFACTURER NARRATIVE

REPORT DATE: 08/27/2002  MDR TEXT KEY: 1438206 

THE ACTUAL SAMPLE WAS NOT MADE AVAILABLE TO THE MFR FOR EVALUATION. WITHOUT THE SAMPLE, A COMPLETE INVESTIGATION COULD NOT BE PERFORMED. BASED ON THE INFO PROVIDED, NO SPECIFIC CONCLUSIONS CAN BE DRAWN.

BRAND NAME

PERIFIX

TYPE OF DEVICE

CONTINUOUS EPIDURAL TRAY

BASELINE BRAND NAME

PERIFIX

BASELINE GENERIC NAME

CONTINUOUS EPIDURAL TRAY

BASELINE CATALOGUE NUMBER

332220

BASELINE MODEL NUMBER

CE18TK

BASELINE DEVICE FAMILY

CONTINUOUS EPIDURAL KIT

BASELINE DEVICE 510(K) NUMBER

K840179

BASELINE SHELF LIFE INFORMATION

YES

IS BASELINE PMA NUMBER PROVIDED?</< TH>

NO

BASELINE PREAMENDMENT?

NO

TRANSITIONAL?

NO

510(K) EXEMPT?

NO

SHELF LIFE(Months)

12

DATE FIRST MARKETED

02/24/1984

MANUFACTURER (Section D)

DEVICE EVENT KEY

393245

MDR REPORT KEY

404253

EVENT KEY

382060

REPORT NUMBER

404253

DEVICE SEQUENCE NUMBER

1

PRODUCT CODE

CAZ

REPORT SOURCE

USER FACILITY

TYPE OF REPORT

INITIAL

REPORT DATE

06/27/2002

1 DEVICE WAS INVOLVED IN THE EVENT

1 PATIENT WAS INVOLVED IN THE EVENT

DATE FDA RECEIVED

07/09/2002

IS THIS AN ADVERSE EVENT REPORT?

YES

IS THIS A PRODUCT PROBLEM REPORT?

NO

DEVICE OPERATOR

HEALTH PROFESSIONAL

DEVICE EXPIRATION DATE

10/31/2003

DEVICE MODEL NUMBER

CE18TK

DEVICE CATALOGUE NUMBER

332220

DEVICE LOT NUMBER

60315607

WAS DEVICE AVAILABLE FOR EVALUATION?

YES

IS THE REPORTER A HEALTH PROFESSIONAL?

YES

WAS THE REPORT SENT TO FDA?

NO

DISTRIBUTOR FACILITY AWARE DATE

06/08/2002

DEVICE AGE

UNKNOWN

EVENT LOCATION

HOSPITAL

PATIENT OUTCOME

HOSPITALIZATION 

ADVERSE EVENT OR PRODUCT PROBLEM DESCRIPTION

REPORT DATE: 06/27/2002  MDR TEXT KEY: 1404325 Patient Sequence Number: 1

AS REPORTED BY USER FACILITY ON MEDWATCH: DURING REMOVAL OF THE EPIDURAL CATHETER IT STRETCHED AND BROKE. AS REPORTED BY USER FACILITY TO MFR: UPON REMOVAL OF THE EPIDURAL CATHETER RESISTANCE WAS MET AND WHEN THEY PULLED THE CATHETER OUT, IT WAS NOT INTACT. DR BELIEVES THIS WAS A 20G CLOSED TIP CATHETER. 5-6 CM WERE VISABLE ON CT SCAN.

BRAND NAME

PERIFIX

TYPE OF DEVICE

CONTINUOUS EPIDURAL TRAY

BASELINE BRAND NAME

PERIFIX

BASELINE GENERIC NAME

CONTINUOUS EPIDURAL TRAY

BASELINE CATALOGUE NUMBER

332229

BASELINE MODEL NUMBER

CE17TKCD

BASELINE DEVICE FAMILY

CONTINUOUS EPIDURAL KIT

BASELINE DEVICE 510(K) NUMBER

K840179

BASELINE SHELF LIFE INFORMATION

YES

IS BASELINE PMA NUMBER PROVIDED?</< TH>

NO

BASELINE PREAMENDMENT?

NO

TRANSITIONAL?

NO

510(K) EXEMPT?

NO

SHELF LIFE(Months)

12

DATE FIRST MARKETED

02/24/1984

MANUFACTURER (Section F)

MANUFACTURER (Section D)

MANUFACTURER CONTACT

DEVICE EVENT KEY

384788

MDR REPORT KEY

395781

EVENT KEY

373935

REPORT NUMBER

2523676-2002-00019

DEVICE SEQUENCE NUMBER

1

PRODUCT CODE

CAZ

REPORT SOURCE

MANUFACTURER

SOURCE TYPE

USER FACILITY

EVENT TYPE

OTHER

TYPE OF REPORT

INITIAL

REPORT DATE

05/01/2002

1 DEVICE WAS INVOLVED IN THE EVENT

1 PATIENT WAS INVOLVED IN THE EVENT

DATE FDA RECEIVED

05/20/2002

IS THIS AN ADVERSE EVENT REPORT?

YES

IS THIS A PRODUCT PROBLEM REPORT?

NO

DEVICE OPERATOR

INVALID DATA

DEVICE EXPIRATION DATE

07/31/2003

IS THE REPORTER A HEALTH PROFESSIONAL?

NO ANSWER PROVIDED

WAS THE REPORT SENT TO FDA?

NO

DEVICE AGE

UNKNOWN

DATE MANUFACTURER RECEIVED

04/25/2002

WAS DEVICE EVALUATED BY MANUFACTURER?

DEVICE NOT RETURNED TO MANUFACTURER

IS THE DEVICE SINGLE USE?

YES

TYPE OF DEVICE USAGE

UNKNOWN

ADDITIONAL MANUFACTURER NARRATIVE

REPORT DATE: 05/20/2002  MDR TEXT KEY: 1373881 

THE ACTUAL DEVICE IS NOT AVAILABLE FOR EVALUATION. BASED ON THE INFORMATION PROVIDED AT THIS TIME NO SPECIFIC CONCLUSIONS CAN BE DRAWN. THE PT HAS, TO DATE, SUFFERED NO ADVERSE EFFFECTS AS A RESULT OF THIS OCCURRENCE. IT SHOULD ALSO BE NOTED THAT THE LABELING ON THE TRAY STATES, "DO NOT WITHDRAW CATHETER THROUGH THE NEEDLE BECAUSE OF POSSIBLE DANGER OF SHEARING".

BRAND NAME

PERIFIX

TYPE OF DEVICE

CONTINUOUS EPIDURAL TRAY

BASELINE BRAND NAME

PERIFIX

BASELINE GENERIC NAME

CONTINUOUS EPIDURAL TRAY

BASELINE CATALOGUE NUMBER

332230

BASELINE MODEL NUMBER

CE18HK

BASELINE DEVICE FAMILY

CONTINUOUS EPIDURAL KIT

BASELINE DEVICE 510(K) NUMBER

K840179

BASELINE SHELF LIFE INFORMATION

YES

IS BASELINE PMA NUMBER PROVIDED?</< TH>

NO

BASELINE PREAMENDMENT?

NO

TRANSITIONAL?

NO

510(K) EXEMPT?

NO

SHELF LIFE(Months)

12

DATE FIRST MARKETED

02/24/1984

MANUFACTURER (Section F)

MANUFACTURER (Section D)

MANUFACTURER CONTACT

DEVICE EVENT KEY

384803

MDR REPORT KEY

395796

EVENT KEY

373950

REPORT NUMBER

2523676-2002-00018

DEVICE SEQUENCE NUMBER

1

PRODUCT CODE

CAZ

REPORT SOURCE

MANUFACTURER

SOURCE TYPE

USER FACILITY

REMEDIAL ACTION

OTHER

EVENT TYPE

INJURY

TYPE OF REPORT

INITIAL

REPORT DATE

04/30/2002

1 DEVICE WAS INVOLVED IN THE EVENT

1 PATIENT WAS INVOLVED IN THE EVENT

DATE FDA RECEIVED

05/20/2002

IS THIS AN ADVERSE EVENT REPORT?

YES

IS THIS A PRODUCT PROBLEM REPORT?

NO

DEVICE OPERATOR

HEALTH PROFESSIONAL

DEVICE EXPIRATION DATE

08/31/2003

DEVICE MODEL NUMBER

CE18HK

DEVICE CATALOGUE NUMBER

332230

DEVICE LOT NUMBER

60293189