BRAND NAME

BD WHITACRE NEEDLE

TYPE OF DEVICE

27G X 4 11/16 LONG WHITACRE SPINAL NEEDLE

BASELINE BRAND NAME

LONG LENGTH WHITACRE PENCIL POINT SPINAL NEEDLES

BASELINE GENERIC NAME

SPINAL NEEDLE

BASELINE CATALOGUE NUMBER

409443

BASELINE DEVICE FAMILY

SPINAL NEEDLES & SPINAL NEEDLE INTRODUCERS

IS BASELINE PMA NUMBER PROVIDED?</< TH>

NO

IS BASELINE 510(K) NUMBER PROVIDED?

NO

BASELINE PREAMENDMENT?

YES

TRANSITIONAL?

NO

510(K) EXEMPT?

NO

SHELF LIFE(Months)

NA

DATE FIRST MARKETED

01/01/1964

MANUFACTURER (Section F)

MANUFACTURER (Section D)

MANUFACTURER CONTACT

DEVICE EVENT KEY

421015

MDR REPORT KEY

432036

EVENT KEY

408766

REPORT NUMBER

2618282-2002-00007

DEVICE SEQUENCE NUMBER

1

PRODUCT CODE

BSP

REPORT SOURCE

MANUFACTURER

SOURCE TYPE

USER FACILITY

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

12/09/2002

IS THIS AN ADVERSE EVENT REPORT?

YES

IS THIS A PRODUCT PROBLEM REPORT?

NO

DEVICE OPERATOR

HEALTH PROFESSIONAL

DEVICE CATALOGUE NUMBER

409443

DEVICE LOT NUMBER

9906958

WAS DEVICE AVAILABLE FOR EVALUATION?

NO

IS THE REPORTER A HEALTH PROFESSIONAL?

NO

WAS THE REPORT SENT TO FDA?

NO

DATE MANUFACTURER RECEIVED

11/12/2002

WAS DEVICE EVALUATED BY MANUFACTURER?

DEVICE NOT RETURNED TO MANUFACTURER

DATE DEVICE MANUFACTURED

03/01/1999

IS THE DEVICE SINGLE USE?

YES

TYPE OF DEVICE USAGE

INITIAL

PATIENT OUTCOME

REQUIRED INTERVENTION 

ADVERSE EVENT OR PRODUCT PROBLEM DESCRIPTION

REPORT DATE: 12/09/2002  MDR TEXT KEY: 1499698 Patient Sequence Number: 1

WHEN INSERTING THE WHITACRE SPINAL NEEDLE INTO A PATIENT, THE NEEDLE BROKE OFF. THE NEEDLE THEN HAD TO BE SURGICALLY REMOVED.

BRAND NAME

BECTON DICKINSON WHITACRE SPINAL NEEDLE

TYPE OF DEVICE

SPINAL NEEDLE 27 GA 3-1/2"

MANUFACTURER (Section D)

DEVICE EVENT KEY

410964

MDR REPORT KEY

421912

EVENT KEY

399043

REPORT NUMBER

421912

DEVICE SEQUENCE NUMBER

1

PRODUCT CODE

BSP

REPORT SOURCE

VOLUNTARY

REPORT DATE

10/09/2002

1 DEVICE WAS INVOLVED IN THE EVENT

1 PATIENT WAS INVOLVED IN THE EVENT

DATE FDA RECEIVED

10/09/2002

IS THIS AN ADVERSE EVENT REPORT?

NO

IS THIS A PRODUCT PROBLEM REPORT?

YES

DEVICE OPERATOR

HEALTH PROFESSIONAL

DEVICE LOT NUMBER

0111989

WAS DEVICE AVAILABLE FOR EVALUATION?

NO ANSWER PROVIDED

PATIENT OUTCOME

OTHER 

ADVERSE EVENT OR PRODUCT PROBLEM DESCRIPTION

REPORT DATE: 10/09/2002  MDR TEXT KEY: 1464432 Patient Sequence Number: 1

BECTON-DICKINSON WHITACRE 27 GAUGE 3-1/2" SPINAL NEEDLES, LOT # 0111989 HAS A DEFECT. NORMALLY IT IS POSSIBLE, EASILY, TO REPLACE THE STYLET WITHIN THE NEEDLE. THE AFOREMENTIONED LOT NUMBER HAS A "RIDGE" WITHIN WHAT SHOULD BE A SMOOTH FUNNEL-SHAPED AREA IN THE NUB OF THE OUTER CANNULA SO THAT THE STYLET MUST BE VERY PRECISELY CENTERED IN ORDER TO BE RE-THREADED WITHIN THE OUTER CANNULA. THIS CAUSES UNNECESSARY DELAY AND PT DISCOMFORT.

BRAND NAME

SPINAL 27G WHITACRE

TYPE OF DEVICE

REGIONAL ANESTHESIA TRAY

BASELINE BRAND NAME

SPINAL 27G WHITCARE

BASELINE GENERIC NAME

ADMINISTRATION SET

BASELINE CATALOGUE NUMBER

15646

BASELINE DEVICE FAMILY

SET, ADM, INTRAVASCULAR

BASELINE SHELF LIFE INFORMATION

*

IS BASELINE PMA NUMBER PROVIDED?</< TH>

NO

IS BASELINE 510(K) NUMBER PROVIDED?

NO

BASELINE PREAMENDMENT?

NO

TRANSITIONAL?

NO

510(K) EXEMPT?

NO

DATE FIRST MARKETED

05/01/1993

MANUFACTURER (Section F)

MANUFACTURER (Section D)

MANUFACTURER (Section G)

MANUFACTURER CONTACT

DEVICE EVENT KEY

351911

MDR REPORT KEY

362773

EVENT KEY

342026

REPORT NUMBER

1018381-2001-00105

DEVICE SEQUENCE NUMBER

1

PRODUCT CODE

FPA

REPORT SOURCE

MANUFACTURER

SOURCE TYPE

HEALTH PROFESSIONAL,COMPANY REPRESENTATIVE

EVENT TYPE

MALFUNCTION

TYPE OF REPORT

INITIAL

REPORT DATE

10/24/2001

1 DEVICE WAS INVOLVED IN THE EVENT

1 PATIENT WAS INVOLVED IN THE EVENT

DATE FDA RECEIVED

11/23/2001

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 CATALOGUE NUMBER

15646

DEVICE LOT NUMBER

78-930-Z1

WAS DEVICE AVAILABLE FOR EVALUATION?

DEVICE NOT RETURNED TO MANUFACTURER

DATE RETURNED TO MANUFACTURER

10/29/2001

IS THE REPORTER A HEALTH PROFESSIONAL?

YES

WAS THE REPORT SENT TO FDA?

NO

DATE MANUFACTURER RECEIVED

10/24/2001

WAS DEVICE EVALUATED BY MANUFACTURER?

NO

DATE DEVICE MANUFACTURED

06/01/2001

IS THE DEVICE SINGLE USE?

YES

TYPE OF DEVICE USAGE

INITIAL

PATIENT OUTCOME

OTHER 

ADVERSE EVENT OR PRODUCT PROBLEM DESCRIPTION

REPORT DATE: 10/24/2001  MDR TEXT KEY: 1260558 Patient Sequence Number: 1

GENERAL REPORT REC'D OF AN UNDOCUMENTED NUMBER OF UNDOCUMENTED INCIDENTS OF A LEAK OCCURRING BETWEEN THE SPINAL NEEDLE HUB AND THE GLASS SYRINGE. THE CUSTOMER REPORTS THAT THIS HAS BEEN OCCURRING ON SURGICAL PATIENTS THAT ARE TO RECEIVE A SPINAL ANESTHETIC. THE SPINAL NEEDLES HAVE BEEN INSERTED WITHOUT PROBLEM. THE CUSTOMER REPORTS THAT THE APPEARANCE OF THE NEEDLES AND SYRINGES DOES NOT SEEM DIFFERENT. STATES THAT WHEN THE SYRINGE IS CONNECTED TO THE HUB OF THE NEEDLE, WITH THE FIRST ATTEMPT TO INJECT THE MEDICATION, THERE IS LEAKAGE OCCURRING IMMEDIATELY. THE LEAK HAS HAPPENED WITH VARIOUS MEDICATIONS. THE PHYSICIANS HAVE TRIED DIFFERENT SYRINGES, BUT THE LEAKGE HAS CONTINUED TO OCCUR. THE AMOUNT OF LEAKAGE VARIES. REPORT SOURCE STATES THAT SOME OF THE PATIENTS DO GET THE EFFECT OF THE ANESTHETIC AND SOME OF THE PATIENTS HAVE NOT ACHIEVED THE ANESTHETIC EFFECT AND THEN REQUIRE GENERAL ANESTHETIC. THERE ARE NO REPORTS OF THE PATIENTS HAVING HAD DIFFICULTIES COMING OUT OF THE GENERAL ANESTHETIC. THERE IS NO REPORT OF ADVERSE PATIENT EVENTS. ADDITIONAL PATIENT INFO WAS REQUESTED, BUT NO FURTHER INFO IS AVAILABLE.

ADDITIONAL MANUFACTURER NARRATIVE

REPORT DATE: 10/24/2001  MDR TEXT KEY: 1260561 

THE SAMPLE WAS REC'D FOR TESTING AND INVESTIGATION ON 10/29/2001. TESTING IS NOT COMPLETE.

BRAND NAME

BD WHITACRE NEEDLE

TYPE OF DEVICE

25G TW X 3 1/2" WHITACRE SPINAL NEEDLE, BNS

BASELINE BRAND NAME

WHITACRE PENCIL POINT SPINAL NEEDLES,BNS

BASELINE GENERIC NAME

SPINAL NEEDLE

BASELINE CATALOGUE NUMBER

400621

BASELINE DEVICE FAMILY

SPINAL NEEDLES

IS BASELINE PMA NUMBER PROVIDED?</< TH>

NO

IS BASELINE 510(K) NUMBER PROVIDED?

NO

BASELINE PREAMENDMENT?

YES

TRANSITIONAL?

NO

510(K) EXEMPT?

NO

SHELF LIFE(Months)

NA

DATE FIRST MARKETED

01/01/1964

MANUFACTURER (Section F)

MANUFACTURER (Section D)

MANUFACTURER CONTACT

DEVICE EVENT KEY

342872

MDR REPORT KEY

353656

EVENT KEY

333201

REPORT NUMBER

2618282-2001-00012

DEVICE SEQUENCE NUMBER

1

PRODUCT CODE

BSP

REPORT SOURCE

MANUFACTURER

EVENT TYPE

INJURY

TYPE OF REPORT

INITIAL

REPORT DATE

09/28/2001

1 DEVICE WAS INVOLVED IN THE EVENT

1 PATIENT WAS INVOLVED IN THE EVENT

DATE FDA RECEIVED

09/28/2001

IS THIS AN ADVERSE EVENT REPORT?

YES

IS THIS A PRODUCT PROBLEM REPORT?

NO

DEVICE OPERATOR

HEALTH PROFESSIONAL

DEVICE CATALOGUE NUMBER

400621

WAS DEVICE AVAILABLE FOR EVALUATION?

YES

IS THE REPORTER A HEALTH PROFESSIONAL?

YES

WAS THE REPORT SENT TO FDA?

NO

DATE MANUFACTURER RECEIVED

09/04/2001

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: 09/28/2001  MDR TEXT KEY: 1228166 Patient Sequence Number: 1

SPINAL NEEDLE BROKE FOLLOWING A CESAREAN SECTION. BROKEN FRAGMENT WAS RETRIEVED SURGICALLY WITH PATIENT UNDER GENERAL ANESTHESIA. BOTH THE CESAREAN SECTION PROCEDURE AND NEEDLE FRAGMENT RETRIEVAL WERE SUCCESSFUL.

ADDITIONAL MANUFACTURER NARRATIVE

REPORT DATE: 09/28/2001  MDR TEXT KEY: 1228169 

BD QUALITY/REGULATORY SYSTEMS HAS EVALUATED THE REPORT AND SAMPLES. THE CONDITION REPORTED HAS BEEN CONFIRMED BASED ON THE ACTUAL SAMPLE RETURNED. THE SAMPLE WAS FORWARDED TO THE MICROSCOPY LABORATORY FOR EXAMINATION. OBSERVATION OF THE SAMPLE IN THE "AS RECEIVED" CONDITION WAS PERFORMED WITH A LOW POWER OPTICAL MICROSCOPE AND REPRESENTATIVE IMAGES WERE RECORDED [OPTICAL PHOTOS 1-7]. NOTE THAT THERE WAS ALSO EVIDENCE OF A SECOND BEND IN THE CANNULA [OPTICAL PHOTO 3]. FURTHERMORE DETAILED EXAMINATION OF THIS SAMPLE WAS PERFORMED BY SCANNING ELECTRON MICROSCOPE [SEM] IN ORDER TO CONFIRM THE FINDING OF BENDING AS A MODE OF FAILURE FOR THIS SAMPLE. A FEW IMPORTANT OBSERVATIONS WERE MADE AT THIS POINT IN THE ANALYSIS WHICH ARE RELEVANT TO IDENTIFICATION OF THIS NEEDLE FAILURE AS A "BENDING" TYPE, THESE ARE: 1. - TUBING OVALITY. IS A DEFORMATION OF THE TUBING FROM CIRCULAR CROSS-SECTIONAL SHAPE TO AN OVAL CROSS-SECTIONAL SHAPE. THIS OCCURS WHEN A RIGID TUBE IS BENT TO SOME DEGREE AWAY FROM ITS NORMAL POSITION. 2. - DEGREE OF BEND AT THE POINT OF FRACTURE. IN SEM PHOTOS 3 & 8, IT IS CLEARLY VISIBLE THAT THE NEEDLE IN THE HUB SHOWS SIGNS OF ANGULARITY, WHICH IS AN INDICATION THAT THE NEEDLE WAS BENT. 3. - MICROVOID COALESCENCE, OR DIMPLING. THIS IS AN IDENTIFYING CHARACTERISTIC OF A DUCTILE FAILURE, AND OCCURS AT A POINT OF MATERIAL SEPARATION. IT WAS CONCLUDED THAT THE MICROSCOPIC EVALUATION OF THIS SAMPLE CLEARLY EXHIBITS THE FOLLOWING ATTRIBUTES: 1. TUBING OVALITY IS CLEARLY EVIDENT. 2. A SECOND BEND OF THE CANNULA IS CLEARLY VISIBLE. 3. MICROVOID COALESCENCE, EVIDENCE OF TENSILE FAILURE OF THE STEEL IS PRESENT. 4. EVIDENCE OF A RESIDUAL BEND IS EXHIBITED AT THE FRACTURE SURFACE. THESE OBSERVATIONS, WHEN VIEWED IN CONTEXT TOGETHER, ARE RELIABLE INDICATORS THAT THE SUBJECT NEEDLE HAS BEEN BENT, THIS LEADING TO FAILURE OF THE NEEDLE. BASED ON THIS ANALYSIS IT HAS BEEN DETERMINED THAT THE BREAKAGE OF THIS NEEDLE DID NOT RESULT FROM ANY MANUFACTURING DEFECT AND THEREFORE NO CORRECTIVE ACTION IS REQUIRED.

BRAND NAME

WHITACRE SPINAL NEEDLE

TYPE OF DEVICE

25 X 3 1/2" SPINAL NEEDLE

BASELINE BRAND NAME

WHITACRE HIGH FLOW PENCIL POINT SPINAL NEEDLE STERILE, SINGLE USE

BASELINE GENERIC NAME

SPINAL NEEDLE

BASELINE CATALOGUE NUMBER

405138

BASELINE DEVICE FAMILY

SPINAL NEEDLES

IS BASELINE PMA NUMBER PROVIDED?</< TH>

NO

IS BASELINE 510(K) NUMBER PROVIDED?

NO

BASELINE PREAMENDMENT?

YES

TRANSITIONAL?

NO

510(K) EXEMPT?

NO

SHELF LIFE(Months)

NA

DATE FIRST MARKETED

01/01/1964

MANUFACTURER (Section F)

MANUFACTURER (Section D)

MANUFACTURER CONTACT

DEVICE EVENT KEY

256150

MDR REPORT KEY

264597

EVENT KEY

247995

REPORT NUMBER

2618282-2000-00002

DEVICE SEQUENCE NUMBER

1

PRODUCT CODE

BSP

REPORT SOURCE

MANUFACTURER

SOURCE TYPE

HEALTH PROFESSIONAL,USER FACILITY

EVENT TYPE

MALFUNCTION

TYPE OF REPORT

INITIAL

REPORT DATE

02/22/2000

1 DEVICE WAS INVOLVED IN THE EVENT

1 PATIENT WAS INVOLVED IN THE EVENT

DATE FDA RECEIVED

02/22/2000

IS THIS AN ADVERSE EVENT REPORT?

YES

IS THIS A PRODUCT PROBLEM REPORT?

NO

DEVICE OPERATOR

HEALTH PROFESSIONAL

DEVICE CATALOGUE NUMBER

405138

WAS DEVICE AVAILABLE FOR EVALUATION?

NO

IS THE REPORTER A HEALTH PROFESSIONAL?

YES

WAS THE REPORT SENT TO FDA?

NO

DATE MANUFACTURER RECEIVED

02/07/2000

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: 02/22/2000  MDR TEXT KEY: 900185 Patient Sequence Number: 1

NEEDLE BROKE OFF IN PT WHILE PERFORMING SPINAL ANESTHESIA, BROKEN END WILL BE SURGICALLY REMOVED. NEEDLE FORWARDED TO HOSPITAL RISK MANAGEMENT-NOT RELEASED.

ADDITIONAL MANUFACTURER NARRATIVE

REPORT DATE: 02/22/2000  MDR TEXT KEY: 900188 

DEVICE NOT RETURNED FOR EVALUATION.

BRAND NAME

WHITACRE NEEDLE

TYPE OF DEVICE

SPINAL NEEDLE

BASELINE BRAND NAME

WHITACRE PENCIL POINT SPINAL NEEDLES,BNS

BASELINE GENERIC NAME

SPINAL NEEDLE

BASELINE CATALOGUE NUMBER

400600

BASELINE DEVICE FAMILY

SPINAL NEEDLES

IS BASELINE PMA NUMBER PROVIDED?</< TH>

NO

IS BASELINE 510(K) NUMBER PROVIDED?

NO

BASELINE PREAMENDMENT?

YES

TRANSITIONAL?

NO

510(K) EXEMPT?

NO

SHELF LIFE(Months)

NA

DATE FIRST MARKETED

01/01/1964

MANUFACTURER (Section F)

MANUFACTURER (Section D)

MANUFACTURER (Section G)

MANUFACTURER CONTACT

DEVICE EVENT KEY

230065

MDR REPORT KEY

237409

EVENT KEY

222752

REPORT NUMBER

2618282-1999-00009

DEVICE SEQUENCE NUMBER

1

PRODUCT CODE

BSP

REPORT SOURCE

MANUFACTURER

SOURCE TYPE

FOREIGN,HEALTH PROFESSIONAL,COMPANY REPRESENTATIVE

EVENT TYPE

MALFUNCTION

TYPE OF REPORT

INITIAL

REPORT DATE

08/18/1999

1 DEVICE WAS INVOLVED IN THE EVENT

1 PATIENT WAS INVOLVED IN THE EVENT

DATE FDA RECEIVED

08/24/1999

IS THIS AN ADVERSE EVENT REPORT?

YES

IS THIS A PRODUCT PROBLEM REPORT?

NO

DEVICE OPERATOR

HEALTH PROFESSIONAL

DEVICE CATALOGUE NUMBER

400600

DEVICE LOT NUMBER

7H707

WAS DEVICE AVAILABLE FOR EVALUATION?

DEVICE NOT RETURNED TO MANUFACTURER

DATE RETURNED TO MANUFACTURER

08/10/1999

IS THE REPORTER A HEALTH PROFESSIONAL?

YES

WAS THE REPORT SENT TO FDA?

NO

DATE MANUFACTURER RECEIVED

08/10/1999

WAS DEVICE EVALUATED BY MANUFACTURER?

YES

DATE DEVICE MANUFACTURED

08/01/1997

IS THE DEVICE SINGLE USE?

YES

TYPE OF DEVICE USAGE

INVALID DATA

PATIENT OUTCOME

REQUIRED INTERVENTION 

ADVERSE EVENT OR PRODUCT PROBLEM DESCRIPTION

REPORT DATE: 08/18/1999  MDR TEXT KEY: 796833 Patient Sequence Number: 1

DURING A SPINAL BIRTHING PROCEDURE, WHILE THE PHYSICIAN WAS INTRODUCING THE NEEDLE, AN INVOLUNTARY MOVEMENT BY THE PT CAUSED THE NEEDLE TO PULL OUT. IT WAS THEN THAT THE PHYSICIAN NOTICED THE NEEDLE HAD BROKEN. ADDITIONAL SURGERY WAS REQUIRED TO REMOVE THE BROKEN END. THE PT WAS NOT HARMED BY THE ADDITIONAL PROCEDURE.

ADDITIONAL MANUFACTURER NARRATIVE

REPORT DATE: 08/24/1999  MDR TEXT KEY: 796834 

BECTON DICKINSON ANESTHESIA SYSTEMS HAS EVALUATED THE REPORT AND SAMPLES. THE SPINAL CANNULA IS BENT AND BROKE, POSSIBLY DUE TO HITTING AN OBSTRUCTION AND APPEARS TO HAVE BEEN BENT AND RESTRAIGHTENED DURING REMOVAL. NORMALLY IF AN OBSTRUCTION IS HIT, THE NEEDLE AND THE INTRODUCER SHOULD BE REMOVED AS ONE, THUS ELIMINATING BENDING AND RESTRAIGHTENING. PT INVOLVEMENT MAY ALSO HAVE CONTRIBUTED TO THE FAILURE OF THE NEEDLE CANNULA. A CLOSE ANALYSIS BY SCANNING ELECTRON MICROSCOPY SUPPORTS NEEDLE FAILURE DUE TO BENDING, RESTRAIGHTENING AND A FINAL TWIST. A COPY OF THE LABRATORY REPORT AND PHOTOS IS ATTACHED. SINCE ADDITIONAL SURGERY WAS REQUIRED TO REMOVE THE BROKEN END OF THE NEEDLE, AN MDR HAS BEEN FILED WITH THE U.S. FDA. A REVIEW OF THE DEVICE HISTORY RECORDS DID NOT REVEAL ANY DIFFICULTY DURING MFG. THE RETENTION SAMPLES WERE ALSO REVIEWED AND FOUND ACCEPTABLE. NO FURTHER ACTION IS EMINENT.

BRAND NAME

25G WHITACRE NEEDLE SPINAL TRAY

TYPE OF DEVICE

ANESTHETIC CONDUCTION KIT

MANUFACTURER (Section F)

MANUFACTURER (Section D)

MANUFACTURER (Section G)

DEVICE EVENT KEY

223217

MDR REPORT KEY

230161

EVENT KEY

216062

REPORT NUMBER

1217052-1999-00023

DEVICE SEQUENCE NUMBER

1

PRODUCT CODE

CAZ

REPORT SOURCE

MANUFACTURER

SOURCE TYPE

HEALTH PROFESSIONAL

EVENT TYPE

INJURY

TYPE OF REPORT

INITIAL

REPORT DATE

06/08/1999

1 DEVICE WAS INVOLVED IN THE EVENT

1 PATIENT WAS INVOLVED IN THE EVENT

DATE FDA RECEIVED

07/06/1999

IS THIS AN ADVERSE EVENT REPORT?

YES

IS THIS A PRODUCT PROBLEM REPORT?

YES

DEVICE OPERATOR

HEALTH PROFESSIONAL

DEVICE EXPIRATION DATE

06/01/2000

DEVICE CATALOGUE NUMBER

4965-25

DEVICE LOT NUMBER

812177

OTHER DEVICE ID NUMBER

NE039

WAS DEVICE AVAILABLE FOR EVALUATION?

YES

IS THE REPORTER A HEALTH PROFESSIONAL?

YES

WAS THE REPORT SENT TO FDA?

NO

DATE MANUFACTURER RECEIVED

06/08/1999

WAS DEVICE EVALUATED BY MANUFACTURER?

DEVICE NOT RETURNED TO MANUFACTURER

DATE DEVICE MANUFACTURED

12/01/1998

IS THE DEVICE SINGLE USE?

YES

TYPE OF DEVICE USAGE

INITIAL

PATIENT OUTCOME

REQUIRED INTERVENTION 

ADVERSE EVENT OR PRODUCT PROBLEM DESCRIPTION

REPORT DATE: 06/08/1999  MDR TEXT KEY: 767926 Patient Sequence Number: 1

THE INTRODUCER NEEDLE HUB DETACHED FROM THE SHAFT REQUIRING SURGICAL REMOVAL.

ADDITIONAL MANUFACTURER NARRATIVE

REPORT DATE: 07/06/1999  MDR TEXT KEY: 767929 

NI ENTRY THROUGHOUT THIS REPORT: SIMS HAS CONTACTED THE RISK MGR AT THE USER FACILITY TO OBTAIN THIS INFO. H.6. EVALUATION CODES: (OTHER): SIMS IS ANTICIPATING THE HUB OF THIS NEEDLE WILL BE RETURNED FOR EVALUATION. SIMS DOES NOT HAVE ANY OF THIS SUSPECT NEEDLE LOT INVENTORY. SIMS HAS NOT RECEIVED ANY SIMILAR REPORTS ON THIS NEEDLE LOT NUMBER FROM ANY OTHER USER.

BRAND NAME

BECTON DICKINSON WHITACRE SPINAL NEEDLE

TYPE OF DEVICE

SPINAL NEEDLE

BASELINE BRAND NAME

WHITACRE HIGH FLOW PENCIL POINT SPINAL NEEDLE STERILE, SINGLE USE

BASELINE GENERIC NAME

SPINAL NEEDLE

BASELINE CATALOGUE NUMBER

405138

BASELINE DEVICE FAMILY

SPINAL NEEDLES

IS BASELINE PMA NUMBER PROVIDED?</< TH>

NO

IS BASELINE 510(K) NUMBER PROVIDED?

NO

BASELINE PREAMENDMENT?

YES

TRANSITIONAL?

NO

510(K) EXEMPT?

NO

SHELF LIFE(Months)

NA

DATE FIRST MARKETED

01/01/1964

MANUFACTURER (Section F)