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)

MANUFACTURER (Section D)

MANUFACTURER (Section G)

MANUFACTURER CONTACT

DEVICE EVENT KEY

222633

MDR REPORT KEY

229565

EVENT KEY

215494

REPORT NUMBER

2618282-1999-00007

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

06/24/1999

1 DEVICE WAS INVOLVED IN THE EVENT

1 PATIENT WAS INVOLVED IN THE EVENT

DATE FDA RECEIVED

06/24/1999

IS THIS AN ADVERSE EVENT REPORT?

YES

IS THIS A PRODUCT PROBLEM REPORT?

NO

DEVICE OPERATOR

HEALTH PROFESSIONAL

DEVICE CATALOGUE NUMBER

405138

DEVICE LOT NUMBER

8M959

WAS DEVICE AVAILABLE FOR EVALUATION?

NO

IS THE REPORTER A HEALTH PROFESSIONAL?

YES

WAS THE REPORT SENT TO FDA?

NO

DATE MANUFACTURER RECEIVED

05/27/1999

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

INVALID DATA

PATIENT OUTCOME

REQUIRED INTERVENTION 

ADVERSE EVENT OR PRODUCT PROBLEM DESCRIPTION

REPORT DATE: 06/24/1999  MDR TEXT KEY: 765683 Patient Sequence Number: 1

A 47 YEAR OLD UNDERWENT AN ARTHROSCOPY FOR A TORN MENISCUS LEFT KNEE. DURING ATTEMPT AT SPINAL ANESTHESIA, DISTAL PORTION OF SPINAL NEEDLE BROKE OFF (APPROX. 1 INCH) IN THE L4 PROCESS. S/P X-RAYS RETURNED TO OR FOR EXPLORATION OF SPINE L4 AREA UNDER FLUOROSCOPY. FOREIGN BODY RETRIEVED AND REMOVED IN IT'S ENTIRETY.

BRAND NAME

SPINAL 25 G WHITACRE

TYPE OF DEVICE

SPINAL NEEDLE

BASELINE BRAND NAME

SPINAL 25 G TRAY WITH DRUGS

BASELINE GENERIC NAME

SPINAL TRAY

BASELINE CATALOGUE NUMBER

15545

BASELINE DEVICE FAMILY

KIT, CONDUCTION, ANESTHESIA

BASELINE SHELF LIFE INFORMATION

*

IS BASELINE PMA NUMBER PROVIDED?</< TH>

NO

IS BASELINE 510(K) NUMBER PROVIDED?

NO

BASELINE PREAMENDMENT?

YES

TRANSITIONAL?

NO

510(K) EXEMPT?

NO

DATE FIRST MARKETED

09/01/1992

MANUFACTURER (Section D)

DEVICE EVENT KEY

216985

MDR REPORT KEY

223744

EVENT KEY

209982

REPORT NUMBER

223744

DEVICE SEQUENCE NUMBER

1

PRODUCT CODE

CAZ

REPORT SOURCE

VOLUNTARY

REPORT DATE

05/17/1999

1 DEVICE WAS INVOLVED IN THE EVENT

1 PATIENT WAS INVOLVED IN THE EVENT

DATE FDA RECEIVED

05/17/1999

IS THIS AN ADVERSE EVENT REPORT?

NO

IS THIS A PRODUCT PROBLEM REPORT?

YES

DEVICE OPERATOR

HEALTH PROFESSIONAL

DEVICE EXPIRATION DATE

12/01/1999

DEVICE LOT NUMBER

45-561-Z1-01

WAS DEVICE AVAILABLE FOR EVALUATION?

YES

PATIENT OUTCOME

OTHER 

ADVERSE EVENT OR PRODUCT PROBLEM DESCRIPTION

REPORT DATE: 05/17/1999  MDR TEXT KEY: 744727 Patient Sequence Number: 1

PT AT FACILITY FOR ELECTIVE C-SECTION. WHILE INSERTING THE NEEDLE TO ADMINISTER SPINAL ANESTHESIA, THE TIP BROKE OFF. ATTEMPTS WERE MADE TO RETRIEVE, BUT WERE UNSUCCESSFUL. STAFF FELT THAT SINCE PT IS ASYMPTOMATIC, IT WAS BEST TO LEAVE TIP IN FOR NOW, AND ATTEMPT WILL BE MADE IN FUTURE IF PT BECOMES SYMPTOMATIC.

BRAND NAME

WHITACRE NEEDLE

TYPE OF DEVICE

25G X 3 1/2" DISPOSABLE SPINAL NEEDLE

BASELINE BRAND NAME

WHITACRE NEEDLE

BASELINE GENERIC NAME

25G X 3 1/2" DISPOSABLE SPINAL NEEDLE

BASELINE CATALOGUE NUMBER

402050

MANUFACTURER (Section F)

MANUFACTURER (Section D)

MANUFACTURER (Section G)

DEVICE EVENT KEY

158418

MDR REPORT KEY

162709

EVENT KEY

152924

REPORT NUMBER

2618282-1998-00004

DEVICE SEQUENCE NUMBER

1

PRODUCT CODE

BSP

REPORT SOURCE

MANUFACTURER

SOURCE TYPE

FOREIGN,USER FACILITY

EVENT TYPE

INJURY

TYPE OF REPORT

INITIAL

REPORT DATE

04/14/1998

1 DEVICE WAS INVOLVED IN THE EVENT

1 PATIENT WAS INVOLVED IN THE EVENT

DATE FDA RECEIVED

04/14/1998

IS THIS AN ADVERSE EVENT REPORT?

YES

IS THIS A PRODUCT PROBLEM REPORT?

NO

DEVICE OPERATOR

HEALTH PROFESSIONAL

DEVICE CATALOGUE NUMBER

402050

DEVICE LOT NUMBER

7D738 OR 7D753

WAS DEVICE AVAILABLE FOR EVALUATION?

YES

IS THE REPORTER A HEALTH PROFESSIONAL?

YES

WAS THE REPORT SENT TO FDA?

NO

DATE MANUFACTURER RECEIVED

03/25/1998

WAS DEVICE EVALUATED BY MANUFACTURER?

YES

DATE DEVICE MANUFACTURED

04/01/1997

IS THE DEVICE SINGLE USE?

YES

TYPE OF DEVICE USAGE

INITIAL

PATIENT OUTCOME

REQUIRED INTERVENTION 

ADVERSE EVENT OR PRODUCT PROBLEM DESCRIPTION

REPORT DATE: 04/14/1998  MDR TEXT KEY: 504948 Patient Sequence Number: 1

DURING SPINAL ANAESTHETIC, THE SPINAL NEEDLE WITH INTRODUCER WAS BEING USED. THERE WAS SOME SLIGHT RESISTANCE TO THE INSERTION OF THE SPINAL NEEDLE. THE INTRODUCER AND SPINAL NEEDLE WERE THEREFORE REMOVED. IT WAS FOUND THAT THE SPINAL NEEDLE HAD BROKEN OFF AT ABOUT 4CM FROM THE TIP AND IT WAS LODGED IN THE PT'S BACK. OPEN SURGERY UNDER GENERAL ANAESTHETIC WAS THEN CARRIED OUT TO REMOVE THE SECTION OF THE NEEDLE LEFT IN THE PT'S BACK.

ADDITIONAL MANUFACTURER NARRATIVE

REPORT DATE: 04/14/1998  MDR TEXT KEY: 504951 

THE BD ANESTHESIA SYSTEMS QUALITY ASSURANCE DEPARTMENT HAS EVALUATED THE REPORT AND SAMPLES. THE SPINAL NEEDLE IS BENT APPROXIMATELY 1 INCH FROM DISTAL TIP AND IS BROKEN AT 1 3/8" FROM DISTAL TIP. THE SPINAL CANNULA IS BENT APPARENTLY FROM HITTING AN OBSTRUCTION AND APPEARS TO HAVE BROKEN FROM BEING PULLED BACK THROUGH THE INTRODUCER NEEDLE. THE SPINAL NEEDLE IS BROKEN AT THE MATCHING AREA WITH POINT OF INTRODUCER NEEDLE. THE NEEDLE WAS BENT PRIOR TO BREAKAGE, POSSIBLY DUE TO HITTING AN OBSTRUCTION, WHICH IS INDICATED BY THE PINCHED END OF THE BROKEN NEEDLE. THE INTRODUCER NEEDLE IS ALSO BENT AND EXHIBITS A HOOKED POINT. CAUTIONS PROVIDED ON THE PACKAGE STATE THAT NO ATTEMPT TO WITHDRAW A BENT NEEDLE THROUGH THE INTRODUCER NEEDLE SHOULD BE MADE. THE SPINAL NEEDLE AND THE INTRODUCER SHALL BE WITHDRAWN AS ONE AND THE PROCEDURE SHOULD BE TRIED AGAIN WITH A NEW SET. A REVIEW OF THE DEVICE HISTORY RECORD DID NOT REVEAL ANY PROBLEMS DURING THE PROCESS. A TOTAL OF TEN RETENTION SAMPLES FROM EACH LOT WERE INSPECTED BUT NO EVIDENCE OF DEFECTS WERE UNCOVERED.

BRAND NAME

WHITACRE NEEDLE

TYPE OF DEVICE

SPINAL NEEDLE

MANUFACTURER (Section F)

MANUFACTURER (Section D)

DEVICE EVENT KEY

144500

MDR REPORT KEY

148288

EVENT KEY

139196

REPORT NUMBER

148288

DEVICE SEQUENCE NUMBER

1

PRODUCT CODE

MIA

REPORT SOURCE

USER FACILITY

TYPE OF REPORT

INITIAL

REPORT DATE

07/03/1997

1 DEVICE WAS INVOLVED IN THE EVENT

1 PATIENT WAS INVOLVED IN THE EVENT

DATE FDA RECEIVED

01/09/1998

IS THIS AN ADVERSE EVENT REPORT?

YES

IS THIS A PRODUCT PROBLEM REPORT?

YES

DEVICE OPERATOR

HEALTH PROFESSIONAL

DEVICE MODEL NUMBER

WHITACRE NEEDLE

DEVICE CATALOGUE NUMBER

27G 3 1/2

DEVICE LOT NUMBER

6M980

WAS DEVICE AVAILABLE FOR EVALUATION?

YES

IS THE REPORTER A HEALTH PROFESSIONAL?

YES

WAS THE REPORT SENT TO FDA?

NO

DISTRIBUTOR FACILITY AWARE DATE

07/01/1997

DEVICE AGE

NA

EVENT LOCATION

HOSPITAL

DATE REPORT TO MANUFACTURER

07/03/1997

PATIENT OUTCOME

REQUIRED INTERVENTION 

ADVERSE EVENT OR PRODUCT PROBLEM DESCRIPTION

REPORT DATE: 07/03/1997  MDR TEXT KEY: 449833 Patient Sequence Number: 1

TIP OF SPINAL NEEDLE BROKE OFF IN PT DURING A PROCEDURE. TIP HAD TO BE SURGICALLY REMOVED.

BRAND NAME

WHITACRE NEEDLE

TYPE OF DEVICE

27G X 3 1/2" DISPOSABLE SPINAL NEEDLE

BASELINE BRAND NAME

WHITACRE NEEDLE

BASELINE GENERIC NAME

27G X 3 1/2" DISPOSABLE SPINAL NEEDLE

BASELINE CATALOGUE NUMBER

405075

MANUFACTURER (Section F)

MANUFACTURER (Section D)

MANUFACTURER (Section G)

DEVICE EVENT KEY

132081

MDR REPORT KEY

135188

EVENT KEY

127115

REPORT NUMBER

2618282-1997-00019

DEVICE SEQUENCE NUMBER

1

PRODUCT CODE

BSP

REPORT SOURCE

MANUFACTURER

SOURCE TYPE

FOREIGN,HEALTH PROFESSIONAL

EVENT TYPE

MALFUNCTION

TYPE OF REPORT

INITIAL

REPORT DATE

11/21/1997

1 DEVICE WAS INVOLVED IN THE EVENT

1 PATIENT WAS INVOLVED IN THE EVENT

DATE FDA RECEIVED

11/25/1997

IS THIS AN ADVERSE EVENT REPORT?

YES

IS THIS A PRODUCT PROBLEM REPORT?

NO

DEVICE OPERATOR

HEALTH PROFESSIONAL

DEVICE EXPIRATION DATE

02/28/2002

DEVICE CATALOGUE NUMBER

405075

DEVICE LOT NUMBER

7B754

WAS DEVICE AVAILABLE FOR EVALUATION?

YES

IS THE REPORTER A HEALTH PROFESSIONAL?

YES

WAS THE REPORT SENT TO FDA?

NO

DATE MANUFACTURER RECEIVED

10/28/1997

WAS DEVICE EVALUATED BY MANUFACTURER?

YES

DATE DEVICE MANUFACTURED

02/01/1997

IS THE DEVICE SINGLE USE?

YES

TYPE OF DEVICE USAGE

INITIAL

PATIENT OUTCOME

REQUIRED INTERVENTION 

ADVERSE EVENT OR PRODUCT PROBLEM DESCRIPTION

REPORT DATE: 11/21/1997  MDR TEXT KEY: 402398 Patient Sequence Number: 1

DURING A RACHI-ANESTHESIA THE CANNULA HAS BEEN BROKEN IN THE BACK OF PATIENT WHEN THE ANESTHESIST WAS TRYING TO RETRIEVE (OR TAKE OFF) THE CANNULA.

ADDITIONAL MANUFACTURER NARRATIVE

REPORT DATE: 11/25/1997  MDR TEXT KEY: 402399 

CO UNDERSTANDS THAT THE CUSTOMER REPORTED THAT THE NEEDLE BROKE OFF IN THE BACK OF THE PATIENT AND A PIECE OF THE NEEDLE REMAINS IN THE BACK OF THE PATIENT. CO LOOKS FORWARD TO MORE INFORMATION AS TO THE CONDITION OF THE PATIENT. THE BD ANESTHESIA SYSTEMS QUALITY ASSURANCE STAFF HAS REVIEWED THE REPORT AND EVALUATED THE SAMPLES CUST RETURNED, AND HAS CONFIRMED THAT THE CANNULA WAS SHEARED WHILE BENDING AND RESTRAIGHTENING IT, OR SHEARED WHILE WITHDRAWING IT THROUGH THE INTRODUCER NEEDLE. TO HELP AVOID NEEDLE BREAKAGE AS LABELING INDICATES, NO ATTEMPT TO STRAIGHTEN A BENT NEEDLE SHOULD BE MADE. IF EXCESS RESISTANCE IS MET THE NEEDLE SHOULD NOT BE FORCED AS DAMAGE MAY OCCUR. THE INTRODUCER NEEDLE AND SPINAL NEEDLE SHOULD BE WITHDRAWN AS ONE, THE NEEDLE SET SHOULD BE DISCARDED, AND THE PROCEDURE COMPLETED WITH A REPLACEMENT SET. THE NEEDLE WILL BE FORWARDED TO THE MICROSCOPY LAB FOR AN SEM PHOTO TO CONFIRM CO'S INITIAL EVALUATION. THAT INFORMATION WILL BE ADDED TO THE FILE AS CO RECEIVES IT. A COPY OF THE REPORT WILL BE FORWARDED TO THE R&D DEPARTMENT FOR REVIEW. THE SAMPLE AND REPORT WILL BE FORWARDED TO THE MANUFACTURING PLANT FOR REVIEW OF THE DEVICE HISTORY RECORD.

BRAND NAME

WHITACRE NEEDLE

TYPE OF DEVICE

27G X 3 1/2" DISPOSABLE SPINAL NEEDLE

BASELINE BRAND NAME

WHITACRE NEEDLE

BASELINE GENERIC NAME

27G X 3 1/2" DISPOSABLE SPINAL NEEDLE

BASELINE CATALOGUE NUMBER

405075

MANUFACTURER (Section F)

MANUFACTURER (Section D)

MANUFACTURER (Section G)

DEVICE EVENT KEY

122394

MDR REPORT KEY

125017

EVENT KEY

117555

REPORT NUMBER

2618282-1997-00018

DEVICE SEQUENCE NUMBER

1

PRODUCT CODE

BSP

REPORT SOURCE

MANUFACTURER

SOURCE TYPE

FOREIGN,USER FACILITY

EVENT TYPE

INJURY

TYPE OF REPORT

INITIAL

REPORT DATE

10/06/1997

1 DEVICE WAS INVOLVED IN THE EVENT

1 PATIENT WAS INVOLVED IN THE EVENT

DATE FDA RECEIVED

10/06/1997

IS THIS AN ADVERSE EVENT REPORT?

YES

IS THIS A PRODUCT PROBLEM REPORT?

NO

DEVICE OPERATOR

HEALTH PROFESSIONAL

DEVICE EXPIRATION DATE

02/28/2002

DEVICE CATALOGUE NUMBER

405075

DEVICE LOT NUMBER

7B754

WAS DEVICE AVAILABLE FOR EVALUATION?

NO

IS THE REPORTER A HEALTH PROFESSIONAL?

YES

WAS THE REPORT SENT TO FDA?

NO

DATE MANUFACTURER RECEIVED

09/09/1997

WAS DEVICE EVALUATED BY MANUFACTURER?

DEVICE NOT RETURNED TO MANUFACTURER

DATE DEVICE MANUFACTURED

02/01/1997

IS THE DEVICE SINGLE USE?

YES

TYPE OF DEVICE USAGE

INITIAL

PATIENT OUTCOME

REQUIRED INTERVENTION 

ADVERSE EVENT OR PRODUCT PROBLEM DESCRIPTION

REPORT DATE: 10/06/1997  MDR TEXT KEY: 362503 Patient Sequence Number: 1

DURING A RACHI-ANESTHESIA THE CANNULA BROKE IN THE BACK OF PT WHEN THE ANESTHESIST WAS TRYING TO RETRIEVE (OR TAKE OFF) THE CANNULA.

BRAND NAME

WHITACRE NEEDLE

TYPE OF DEVICE

27G X 3 1/2" DISPOSABLE SPINAL NEEDLE

MANUFACTURER (Section F)

MANUFACTURER (Section D)

MANUFACTURER (Section G)

DEVICE EVENT KEY

111422

MDR REPORT KEY

113499

EVENT KEY

106722

REPORT NUMBER

2618282-1997-00017

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

08/15/1997

1 DEVICE WAS INVOLVED IN THE EVENT

1 PATIENT WAS INVOLVED IN THE EVENT

DATE FDA RECEIVED

08/15/1997

IS THIS AN ADVERSE EVENT REPORT?

YES

IS THIS A PRODUCT PROBLEM REPORT?

NO

DEVICE OPERATOR

HEALTH PROFESSIONAL

DEVICE CATALOGUE NUMBER

402051

DEVICE LOT NUMBER

6M980

WAS DEVICE AVAILABLE FOR EVALUATION?

NO

IS THE REPORTER A HEALTH PROFESSIONAL?

YES

WAS THE REPORT SENT TO FDA?

NO

DATE MANUFACTURER RECEIVED

07/24/1997

WAS DEVICE EVALUATED BY MANUFACTURER?

DEVICE NOT RETURNED TO MANUFACTURER

DATE DEVICE MANUFACTURED

12/01/1996

IS THE DEVICE SINGLE USE?

YES

TYPE OF DEVICE USAGE

INITIAL

PATIENT OUTCOME

REQUIRED INTERVENTION 

ADVERSE EVENT OR PRODUCT PROBLEM DESCRIPTION

REPORT DATE: 08/15/1997  MDR TEXT KEY: 319972 Patient Sequence Number: 1

NEEDLE BROKE IN USE. BROKEN PORTION OF NEEDLE REMAINED IN PT AND HAD TO BE REMOVED SURGICALLY.

BRAND NAME

WHITACRE NEEDLE

TYPE OF DEVICE

NEEDLE, SPINAL

MANUFACTURER (Section F)

MANUFACTURER (Section D)

DEVICE EVENT KEY

103337

MDR REPORT KEY

105087

EVENT KEY

98783

REPORT NUMBER

105087

DEVICE SEQUENCE NUMBER

1

PRODUCT CODE

BSP

REPORT SOURCE

USER FACILITY

TYPE OF REPORT

INITIAL

REPORT DATE

01/21/1997

1 DEVICE WAS INVOLVED IN THE EVENT

1 PATIENT WAS INVOLVED IN THE EVENT

DATE FDA RECEIVED

07/01/1997

IS THIS AN ADVERSE EVENT REPORT?

YES

IS THIS A PRODUCT PROBLEM REPORT?

NO

DEVICE OPERATOR

HEALTH PROFESSIONAL

DEVICE MODEL NUMBER

WHITACRE NEEDLE

DEVICE CATALOGUE NUMBER

405079

OTHER DEVICE ID NUMBER

27G3.5

WAS DEVICE AVAILABLE FOR EVALUATION?

YES

IS THE REPORTER A HEALTH PROFESSIONAL?

YES

WAS THE REPORT SENT TO FDA?

NO

DISTRIBUTOR FACILITY AWARE DATE

01/03/1997

EVENT LOCATION

HOSPITAL

DATE REPORT TO MANUFACTURER

01/04/1997

PATIENT OUTCOME

REQUIRED INTERVENTION 

ADVERSE EVENT OR PRODUCT PROBLEM DESCRIPTION

REPORT DATE: 01/21/1997  MDR TEXT KEY: 291342 Patient Sequence Number: 1

DURING SPINAL TAP, GIVEN PRE-DELIVERY, THE NEEDLE BROKE INTO, APPROX. 1" FROM THE END. THE PT DELIVERED WITHOUT INCIDENT, AND WAS TAKEN TO X-RAY FOR SURGERY TO REMOVE. NEEDLE WAS REMOVED SUCCESSFULLY, AND PT OKAY. NOTE: THE ORIGINAL REPORT WAS MADE VERBALLY ON 1/4/97 TO BECTON DICKINSON. THE REMAINING NEEDLES OF THIS BRAND AND CATALOG NUMBER WERE REMOVED FROM STOCK AND RETURNED TO THE MFR.

BRAND NAME

SPINAL NDL. SET 25 GAUGE WHITACRE

TYPE OF DEVICE

SPINAL NEEDLE (WHITACARE)

BASELINE BRAND NAME

SPINAL NEEDLE, WHITCARE

BASELINE GENERIC NAME

SPINAL TRAY

BASELINE CATALOGUE NUMBER

0M122

BASELINE DEVICE FAMILY

KIT, INDUCTION, ANESTHESIA

BASELINE SHELF LIFE INFORMATION

YES

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)

12

MANUFACTURER (Section F)

MANUFACTURER (Section D)

MANUFACTURER (Section G)

MANUFACTURER CONTACT

DEVICE EVENT KEY

88458

MDR REPORT KEY

89478

EVENT KEY

84119

REPORT NUMBER

1018381-1997-00019

DEVICE SEQUENCE NUMBER

1

PRODUCT CODE

BSP

REPORT SOURCE

MANUFACTURER

SOURCE TYPE

FOREIGN

EVENT TYPE

MALFUNCTION

TYPE OF REPORT

INITIAL

REPORT DATE

04/08/1997

1 DEVICE WAS INVOLVED IN THE EVENT

1 PATIENT WAS INVOLVED IN THE EVENT

DATE FDA RECEIVED

05/03/1997

IS THIS AN ADVERSE EVENT REPORT?

NO

IS THIS A PRODUCT PROBLEM REPORT?

YES

DEVICE OPERATOR

HEALTH PROFESSIONAL

DEVICE CATALOGUE NUMBER

0M122

DEVICE LOT NUMBER

25-505-VM

WAS DEVICE AVAILABLE FOR EVALUATION?

DEVICE NOT RETURNED TO MANUFACTURER

IS THE REPORTER A HEALTH PROFESSIONAL?

YES

WAS THE REPORT SENT TO FDA?

NO

DISTRIBUTOR FACILITY AWARE DATE

04/07/1997

DEVICE AGE

5 MO

EVENT LOCATION

HOSPITAL

DATE MANUFACTURER RECEIVED

04/08/1997

WAS DEVICE EVALUATED BY MANUFACTURER?

YES

DATE DEVICE MANUFACTURED

01/01/1989

IS THE DEVICE SINGLE USE?

YES

TYPE OF DEVICE USAGE

INITIAL

PATIENT OUTCOME

OTHER 

ADVERSE EVENT OR PRODUCT PROBLEM DESCRIPTION

REPORT DATE: 04/08/1997  MDR TEXT KEY: 234555 Patient Sequence Number: 1

DURING INDUCTION OF SPINAL ANESTHESIA FOR VARICOSE SURGERY, A SPINAL NEEDLE REPORTEDLY "TOUCHED" A LUMBAR VERTEBRA AND BROKE. UPON RECOMMENDATION OF A NEUROSURGEON, NO ATTEMPT WAS MADE TO REMOVE THE DISTAL FRAGMENT OF THE NEEDLE FROM THE PT.

ADDITIONAL MANUFACTURER NARRATIVE

REPORT DATE: 04/08/1997  MDR TEXT KEY: 234558 

THE RETURNED SAMPLE CONSISTED OF A SPINAL NEEDLE WITH A SEGMENT ABOUT 25 MM IN LENGTH MISSING FROM THE TIP AND A STYLET LOCATED SEPARATELY IN THE PACKAGING. THE 25 MM SEGMENT OF THE TIP WAS MISSING ENTIRELY. THERE WAS A SECONDARY BEND ON THE NEEDLE AT THE SITE WHERE IT PROTRUDED FROM THE BEVEL OF THE INTRODUCER NEEDLE. EXAM UNDER MAGNIFICATION OF THE BEAKAGE SITE ON THE PROXIMAL PORTION OF THE NEEDLE SHOWED CHARACTERISTICS CONSISTENT WITH THE NEEDLE HAVING BEEN BENT BACKWARDS AND FORWARDS WITH NO STYLET IN PLACE PRIOR TO DETACHMENT. FINDINGS WERE REPRODUCED USING A NEEDLE FROM THE STORES AT THE MFG SITE. THE STYLET WAS REMOVED, AND THE NEEDLE WAS BENT OVER AND BACK UNTIL A PIECE ABOUT 25 MM LONG SNAPPED OFF. EXAM OF THE BREAKAGE SITE UNDER MAGNIFICATION SHOWED THE SAME CHARACTERISTICS OF THE RETURNED SAMPLE. FURTHER EXAM USING ANOTHER NEEDLE WITH A STYLET IN PLACE SHOWED THAT THE NEEDLE COULD ONLY BE BENT FORWARD, THE STYLET PREVENTING ANY BACKWARD BENDING. WHEN THE NEEDLE WAS BENT WITH THE STYLET IN PLACE, THE STYLET COULD NOT BE REMOVED. IF THE STYLET HAD BEEN IN PLACE DURING INTRODUCTION OF THE NEEDLE INTO A PT IN ORDER TO PROVIDE ADD'L STRENGTH AND RIGIDITY. THE FINDINGS ARE HIGHLY SUGGESTIVE OF ROUGH HANDLING OF THE DEVICE BY THE CLINICIAN.

BRAND NAME

BECTON DICKINSON WHITACRE NEEDLE

TYPE OF DEVICE

27G X 3 1/2" DISPOSABLE SPINAL NEEDLE

BASELINE BRAND NAME

WHITACRE PENCIL POINT SPINAL NEEDLES

BASELINE GENERIC NAME

SPINAL NEEDLE

BASELINE CATALOGUE NUMBER

405079

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 (Section G)

MANUFACTURER CONTACT

DEVICE EVENT KEY

68467

MDR REPORT KEY

72957

EVENT KEY

64373

REPORT NUMBER

2618282-1997-00004

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

02/24/1997

1 DEVICE WAS INVOLVED IN THE EVENT

1 PATIENT WAS INVOLVED IN THE EVENT

DATE FDA RECEIVED

02/25/1997

IS THIS AN ADVERSE EVENT REPORT?

YES

IS THIS A PRODUCT PROBLEM REPORT?

YES

DEVICE OPERATOR

HEALTH PROFESSIONAL

DEVICE CATALOGUE NUMBER

405079

WAS DEVICE AVAILABLE FOR EVALUATION?

YES

IS THE REPORTER A HEALTH PROFESSIONAL?

YES

WAS THE REPORT SENT TO FDA?

NO

DEVICE AGE

NA

EVENT LOCATION

NOT APPLICABLE

DATE MANUFACTURER RECEIVED

02/06/1997

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: 02/24/1997  MDR TEXT KEY: 176570 Patient Sequence Number: 1

SHEARING OF APPROX 2CM OF SPINAL NEEDLE TIP. PT WAS SCHEDULED FOR ELECTIVE CESAREAN SECTION. PT HAD AN EPIDURAL, BUT ONLY A PARTIAL BLOCK WAS OBTAINED. PT WAS TO RECEIVE SPINAL BLOCK. DURING THE PROCESS OF SPINAL BLOCK, PT'S PARTNER GOT DIZZY AND FAINTED AND WAS CAUGHT BY ANESTHESIOLOGIST. NURSE ANESTHETIST WAS DOING SPINAL BLOCK, AS THE NEEDLE WAS PULLED OUT APPROX 2 CM OF NEEDLE WAS LEFT IN PT. SURGERY WAS CANCELLED. NEUROSURGEON CONSULTED.

ADDITIONAL MANUFACTURER NARRATIVE

REPORT DATE: 02/25/1997  MDR TEXT KEY: 176573 

CO'S ENGINEERING STAFF HAS CONFIRMED THAT THE CANNULA WAS SHEARED WHILE BENDING AND RESTRAIGHTENING IT, OR SHEARED WHILE WITHDRAWING IT THROUGH THE INTRODUCER NEEDLE. TO HELP AVOID NEEDLE BREAKAGE AS LABELING INDICATES, NO ATTEMPT TO STRAIGHTEN A BENT NEEDLE SHOULD BE MADE. IF EXCESS RESISTANCE IS MET DO NOT FORCE THE NEEDLE AS DAMAGE MAY OCCUR. THE INTRODUCER NEEDLE AND SPINAL NEEDLE SHOULD BE WITHDRAWN AS ONE, THE NEEDLE SET SHOULD BE DISCARDED, AND THE PROCEDURE COMPLETED WITH A REPLACEMENT SET.

BRAND NAME

B-D WHITACRE NEEDLE

TYPE OF DEVICE

SPINAL NEEDLE

MANUFACTURER (Section D)

DEVICE EVENT KEY

68345

MDR REPORT KEY

68348

EVENT KEY

64253

REPORT NUMBER

68348

DEVICE SEQUENCE NUMBER

1

PRODUCT CODE

BSP

REPORT SOURCE

USER FACILITY

TYPE OF REPORT

INITIAL

REPORT DATE

02/03/1997,02/02/1997

1 DEVICE WAS INVOLVED IN THE EVENT

1 PATIENT WAS INVOLVED IN THE EVENT

DATE FDA RECEIVED

02/13/1997

IS THIS AN ADVERSE EVENT REPORT?

YES

IS THIS A PRODUCT PROBLEM REPORT?

YES

DEVICE OPERATOR

HEALTH PROFESSIONAL

DEVICE MODEL NUMBER

PRODUCT # 405079

DEVICE CATALOGUE NUMBER

405079

OTHER DEVICE ID NUMBER

SIZE 27G 3 1/2

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

01/27/1997

EVENT LOCATION

INVALID DATA

PATIENT OUTCOME

OTHER 

ADVERSE EVENT OR PRODUCT PROBLEM DESCRIPTION

REPORT DATE: 02/02/1997  MDR TEXT KEY: 160762 Patient Sequence Number: 1

SHEARING OF APPROX 2 CM OF SPINAL NEEDLE TIP. THE 40 WEEK PT WAS SCHEDULED FOR CEASEREAN SECTION DUE TO FAILED INDUCTION AND OTHER FACTORS. IN COURSE OF SPINAL ANESTHETIC, ON 1ST INTRODUCTION OF INTRODUCER AND NEEDLE, UNIT WAS PASSED TO HUB WITH NO CSF RETURN. A "CRACK" WAS FELT AS UNIT ASSEMBLY EXITED WITH OBVIOUS LOSS OF PORTION (APPROX 2 CM) OF SPINAL NEEDLE. NEUROSURGEON WAS CONSULTED.

BRAND NAME

WHITACRE NEEDLE

TYPE OF DEVICE

SPIRAL NEEDLE

BASELINE BRAND NAME

WHITACRE PENCIL POINT SPINAL NEEDLES

BASELINE GENERIC NAME

SPINAL NEEDLE

BASELINE CATALOGUE NUMBER

405079

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 D)

DEVICE EVENT KEY

68467

MDR REPORT KEY

68485

EVENT KEY

64373

REPORT NUMBER

68485

DEVICE SEQUENCE NUMBER

1

PRODUCT CODE

BSP

REPORT SOURCE

VOLUNTARY

REPORT DATE

02/02/1997

1 DEVICE WAS INVOLVED IN THE EVENT

1 PATIENT WAS INVOLVED IN THE EVENT

DATE FDA RECEIVED

02/13/1997

IS THIS AN ADVERSE EVENT REPORT?

NO

IS THIS A PRODUCT PROBLEM REPORT?

YES

DEVICE OPERATOR

HEALTH PROFESSIONAL

DEVICE MODEL NUMBER

PRODUCT # 405079

DEVICE CATALOGUE NUMBER

#405079

DEVICE LOT NUMBER

UNSURE

OTHER DEVICE ID NUMBER

SIZE: 27 G 3 1/2

WAS DEVICE AVAILABLE FOR EVALUATION?

YES

ADVERSE EVENT OR PRODUCT PROBLEM DESCRIPTION

REPORT DATE: 02/02/1997  MDR TEXT KEY: 161178 Patient Sequence Number: 1

PT WAS SCHEDULED FOR ELECTIVE CESAREAN SECTION. PT HAD AN EPIDURAL, BUT ONLY A PARTIAL BLOCK WAS OBTAINED. PT WAS TO RECEIVE SPINAL BLOCK. DURING THE PROCESS OF SPINAL BLOCK, PT'S PARTNER GOT DIZZY AND FAINTED AND WAS CAUGHT BY ANESTHESIOLOGIST. NURSE ANESTHETIST WAS DOING SPINAL BLOCK, AS THE NEEDLE WAS PULLED OUT, APPROX 2CM OF NEEDLE WAS LEFT INSIDE PT. SURGERY WAS CANCELLED. NEUROSURGEON CONSULTED.

BRAND NAME

BECTON DICKINSON WHITACRE NEEDLE

TYPE OF DEVICE

27G X 3 1/2" DISPOSABLE SPINAL NEEDLE

BASELINE BRAND NAME

SPINAL NEEDLES

BASELINE GENERIC NAME

SPINAL NEEDLE

BASELINE CATALOGUE NUMBER

405081

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 (Section G)

MANUFACTURER CONTACT

DEVICE EVENT KEY

69897

MDR REPORT KEY

69964

EVENT KEY

65791

REPORT NUMBER

2618282-1997-00002

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

02/07/1997

1 DEVICE WAS INVOLVED IN THE EVENT

1 PATIENT WAS INVOLVED IN THE EVENT

DATE FDA RECEIVED

02/11/1997

IS THIS AN ADVERSE EVENT REPORT?

YES

IS THIS A PRODUCT PROBLEM REPORT?

YES

DEVICE OPERATOR

HEALTH PROFESSIONAL

DEVICE CATALOGUE NUMBER

405081

WAS DEVICE AVAILABLE FOR EVALUATION?

YES

IS THE REPORTER A HEALTH PROFESSIONAL?

YES

WAS THE REPORT SENT TO FDA?

NO

EVENT LOCATION

INVALID DATA

DATE MANUFACTURER RECEIVED

01/15/1997

WAS DEVICE EVALUATED BY MANUFACTURER?

YES

DATE DEVICE MANUFACTURED

03/01/1995

IS THE DEVICE SINGLE USE?

YES

TYPE OF DEVICE USAGE

INITIAL

PATIENT OUTCOME

REQUIRED INTERVENTION 

ADVERSE EVENT OR PRODUCT PROBLEM DESCRIPTION

REPORT DATE: 02/07/1997  MDR TEXT KEY: 165793 Patient Sequence Number: 1

ANESTHESIOLOGIST STRUCK BONE WHEN INSERTING THE NEEDLE. HE PULLED BACK THE NEEDLE AND TRIED AGAIN. WHEN HE DIDN'T GET ANY LIQUOR RESPONSE HE PULLED BACK AND FORTH A COUPLE OF TIME. WHEN THIS DIDN'T WORK, HE INTENDED TO PULL THE WHOLE NEEDLE OUT TO TRY THE PROCEDURE FROM THE BEGINNING (USING THE SAME NEEDLE). WHEN HE TRIED TO PULL OUT THE NEEDLE, IT BROKE AND A PIECE WAS LEFT IN THE PT. IT WAS LATER REMOVED SURGICALLY.

ADDITIONAL MANUFACTURER NARRATIVE

REPORT DATE: 02/11/1997  MDR TEXT KEY: 165796 

CO'S ENGINEERING STAFF HAS REVIEWED THE REPORT AND EXAMINED THE SAMPLE RETURNED, AND HAS CONFIRMED THAT THE CANNULA WAS SHEARED WHILE BENDING AND RESTRAIGHTENING IT, OR SHEARED WHILE WITHDRAWING IT THROUGH THE INTRODUCER NEEDLE. TO HELP AVOID NEEDLE BREAKAGE AS LABELING INDICATES, NO ATTEMPT TO STRAIGHTEN A BENT NEEDLE SHOULD BE MADE. IF EXCESS RESISTANCE IS MET THE NEEDLE SHOULD NOT BE FORCED AS DAMAGE MAY OCCUR. THE INTRODUCER NEEDLE AND SPINAL NEEDLE SHOULD WITHDRAWN AS ONE, THE NEEDLE SET SHOULD BE DISCARDED, AND THE PROCEDURE COMPLETED WITH A REPLACEMENT SET. THIS IS ONLY THE SECOND INCIDENT WITH THIS PARTICULAR CATALOGUE NUMBER SINCE 1993. THE MANUFACTURING PLANT WILL BE NOTIFIED OF THIS INCIDENT FOR THEIR REVIEW.

BRAND NAME

WHITACRE NEEDLE

TYPE OF DEVICE

SPINAL NEEDLE

MANUFACTURER (Section D)

DEVICE EVENT KEY

63716

MDR REPORT KEY

63537

EVENT KEY

59706

REPORT NUMBER

63537

DEVICE SEQUENCE NUMBER

1

PRODUCT CODE

BSP

REPORT SOURCE

USER FACILITY

TYPE OF REPORT

INITIAL

REPORT DATE

01/15/1997

1 DEVICE WAS INVOLVED IN THE EVENT

1 PATIENT WAS INVOLVED IN THE EVENT

DATE FDA RECEIVED

01/16/1997

IS THIS AN ADVERSE EVENT REPORT?

NO

IS THIS A PRODUCT PROBLEM REPORT?

YES

DEVICE OPERATOR

HEALTH PROFESSIONAL

DEVICE MODEL NUMBER

WHITACRE NEEDLE

DEVICE CATALOGUE NUMBER

405079

DEVICE LOT NUMBER

65966

OTHER DEVICE ID NUMBER

2763 1/2

WAS DEVICE AVAILABLE FOR EVALUATION?

YES

IS THE REPORTER A HEALTH PROFESSIONAL?

YES

WAS THE REPORT SENT TO FDA?

YES

DATE REPORT TO FDA

01/15/1997

DISTRIBUTOR FACILITY AWARE DATE

01/08/1997

EVENT LOCATION

HOSPITAL

DATE REPORT TO MANUFACTURER

01/14/1997

PATIENT OUTCOME

OTHER  REQUIRED INTERVENTION 

ADVERSE EVENT OR PRODUCT PROBLEM DESCRIPTION

REPORT DATE: 01/15/1997  MDR TEXT KEY: 143987 Patient Sequence Number: 1

DURING ATTEMPT AT SPINAL ANESTHESIA THE NEEDLE SHEARED OFF IN PT WHILE BEING WITHDRAWN FROM INTRO NEEDLE BY THE ANESTHESIOLOGIST. APPROX 1 1/4 INCHES OF NEEDLE REMAINS IN PT SPINAL AREA. ATTEMPTS MADE BY THE SURGEON TO RETRIEVE THE BROKEN NEEDLE WERE UNSUCCESSFUL.

BRAND NAME

BECTON-DICKINSON WHITACRE NEEDLE

TYPE OF DEVICE

27 GAUGE SPINAL NEEDLE 3-1/2"

MANUFACTURER (Section F)

MANUFACTURER (Section D)

DEVICE EVENT KEY

58644

MDR REPORT KEY

58161

EVENT KEY

54674

REPORT NUMBER

58161

DEVICE SEQUENCE NUMBER

1

PRODUCT CODE

BSP

REPORT SOURCE

USER FACILITY

TYPE OF REPORT

INITIAL

REPORT DATE

07/26/1996,07/22/1996

1 DEVICE WAS INVOLVED IN THE EVENT

1 PATIENT WAS INVOLVED IN THE EVENT

DATE FDA RECEIVED

12/18/1996

IS THIS AN ADVERSE EVENT REPORT?

NO

IS THIS A PRODUCT PROBLEM REPORT?

YES

DEVICE OPERATOR

HEALTH PROFESSIONAL

DEVICE MODEL NUMBER

405079

WAS DEVICE AVAILABLE FOR EVALUATION?

NO

IS THE REPORTER A HEALTH PROFESSIONAL?

YES

WAS THE REPORT SENT TO FDA?

NO

DISTRIBUTOR FACILITY AWARE DATE

07/22/1996

EVENT LOCATION

HOSPITAL

DATE REPORT TO MANUFACTURER

07/22/1996

PATIENT OUTCOME

REQUIRED INTERVENTION 

ADVERSE EVENT OR PRODUCT PROBLEM DESCRIPTION

REPORT DATE: 07/22/1996  MDR TEXT KEY: 126182 Patient Sequence Number: 1

A 27 GAUGE SPINAL NEEDLE TIP WAS SHEARED OFF DURING PLACEMENT OF SPINAL ANESTHESIA FOR CESAREAN SECTION. REQUIRED A LOCAL EXPLORATION FOR REMOVAL OF NEEDLE FRAGMENT. PT DID NOT SUFFER ANY IMPAIRMENT. RPTR DOES NOT BELIEVE THIS WAS A USER ERROR ISSUE.

BRAND NAME

BECTON DICKINSON WHITACRE NEEDLE

TYPE OF DEVICE

27G X 3 1/2" DISPOSABLE SPINAL NEEDLE

BASELINE BRAND NAME

WHITACRE PENCIL POINT SPINAL NEEDLES

BASELINE GENERIC NAME

SPINAL NEEDLE

BASELINE CATALOGUE NUMBER

405079

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 (Section G)

MANUFACTURER CONTACT

DEVICE EVENT KEY

41691

MDR REPORT KEY

40598

EVENT KEY

38043

REPORT NUMBER

2618282-1996-00002

DEVICE SEQUENCE NUMBER

1

PRODUCT CODE

BSP

REPORT SOURCE

MANUFACTURER

SOURCE TYPE

HEALTH PROFESSIONAL,USER FACILITY

EVENT TYPE

INJURY

TYPE OF REPORT

INITIAL

REPORT DATE

07/26/1996,09/05/1996

1 DEVICE WAS INVOLVED IN THE EVENT

1 PATIENT WAS INVOLVED IN THE EVENT

DATE FDA RECEIVED

09/11/1996

IS THIS AN ADVERSE EVENT REPORT?

NO

IS THIS A PRODUCT PROBLEM REPORT?

YES

DEVICE OPERATOR

HEALTH PROFESSIONAL

DEVICE CATALOGUE NUMBER

405079

WAS DEVICE AVAILABLE FOR EVALUATION?

NO

IS THE REPORTER A HEALTH PROFESSIONAL?

YES

WAS THE REPORT SENT TO FDA?

YES

DISTRIBUTOR FACILITY AWARE DATE

07/22/1996

DEVICE AGE

UNKNOWN

EVENT LOCATION

HOSPITAL

DATE REPORT TO MANUFACTURER

07/22/1996

DATE MANUFACTURER RECEIVED

08/16/1996

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: 09/05/1996  MDR TEXT KEY: 66092 Patient Sequence Number: 1

A 27 GAUGE SINAL NEEDLE TIP WAS SHEARED OFF DURING PLACEMENT OF SPINAL ANESTHESIA FOR CESAREAM SECTION. REQUIRED A LOCAL EXPLORATION FOR REMOVAL OF NEEDLE FRAGMENT. PT DID NOT SUFFER ANY IMPAIRMENT.

ADDITIONAL MANUFACTURER NARRATIVE

REPORT DATE: 09/11/1996  MDR TEXT KEY: 66095 

NA

BRAND NAME

BECTON-DICKINSON WHITACRE NEEDLE

TYPE OF DEVICE

27 GAUGE SPINAL NEEDLE 3-1/2"

MANUFACTURER (Section F)

MANUFACTURER (Section D)

DEVICE EVENT KEY

36447

MDR REPORT KEY

35030

EVENT KEY

32923

REPORT NUMBER

35030

DEVICE SEQUENCE NUMBER

1

PRODUCT CODE

BSP

REPORT SOURCE

USER FACILITY

TYPE OF REPORT

INITIAL

REPORT DATE

07/26/1996,07/22/1996

1 DEVICE WAS INVOLVED IN THE EVENT

1 PATIENT WAS INVOLVED IN THE EVENT

DATE FDA RECEIVED

07/26/1996

IS THIS AN ADVERSE EVENT REPORT?

NO

IS THIS A PRODUCT PROBLEM REPORT?

YES

DEVICE OPERATOR

HEALTH PROFESSIONAL

DEVICE MODEL NUMBER

405079

WAS DEVICE AVAILABLE FOR EVALUATION?

NO

IS THE REPORTER A HEALTH PROFESSIONAL?

YES

WAS THE REPORT SENT TO FDA?

NO

DISTRIBUTOR FACILITY AWARE DATE

07/22/1996

DEVICE AGE

NA

EVENT LOCATION

HOSPITAL

DATE REPORT TO MANUFACTURER

07/22/1996

PATIENT OUTCOME

REQUIRED INTERVENTION 

ADVERSE EVENT OR PRODUCT PROBLEM DESCRIPTION

REPORT DATE: 07/22/1996  MDR TEXT KEY: 50109 Patient Sequence Number: 1

A 27 GAUGE SPINAL NEEDLE TIP WAS SHEARED OFF DURING PLACEMENT OF SPINAL ANESTHESIA FOR CESAREAN SECTION. REQUIRED A LOCAL EXPLORATION FOR REMOVAL OF NEEDLE FRAGMENT. PT DID NOT SUFFER ANY IMPAIRMENT. CO DOES NOT BELIEVE THIS WAS A USER ERROR ISSUE.

BRAND NAME

WHITACRE SPINAL NEEDLE

TYPE OF DEVICE

SPINAL NEEDLE

MANUFACTURER (Section D)

DEVICE EVENT KEY

34554

MDR REPORT KEY

33234

EVENT KEY

31218

REPORT NUMBER

33234

DEVICE SEQUENCE NUMBER

1

PRODUCT CODE

MIA

REPORT SOURCE

VOLUNTARY

REPORT DATE

05/28/1996

1 DEVICE WAS INVOLVED IN THE EVENT

1 PATIENT WAS INVOLVED IN THE EVENT

DATE FDA RECEIVED

05/29/1996

IS THIS AN ADVERSE EVENT REPORT?

NO

IS THIS A PRODUCT PROBLEM REPORT?

YES

DEVICE OPERATOR

HEALTH PROFESSIONAL

DEVICE EXPIRATION DATE

09/01/1997

DEVICE MODEL NUMBER

1 T 2356

DEVICE LOT NUMBER

GD530568

WAS DEVICE AVAILABLE FOR EVALUATION?

YES

PATIENT OUTCOME

OTHER 

ADVERSE EVENT OR PRODUCT PROBLEM DESCRIPTION

REPORT DATE: 05/28/1996  MDR TEXT KEY: 46597 Patient Sequence Number: 1

AFTER BETADINE PREP AND DRAPE, 25GA NEEDLE INSERTED AT L3-L4 WITH PT RIGHT SIDE DOWN. STYLET WITHDRAWN AND SMALL DARK FOREIGN BODY NOTED INSIDE NEEDLE HUB. CSF FLOWING OUT, FLOATED FOREIGN BODY TO EDGE OF HUB. NEEDLE MOVED AND SENT TO PATHOLOGY. SECOND 25GA NEEDLE INSERTED AND SUCCESSFUL SPINAL ANESTHESIA OBTAINED. NEEDLE SENT TO PATHOLOGY FOR EXAMINATION AND CULTURE. NONE (PT'S OPERATION WAS TO BE RIGHT INGUINAL HERNIORRAPHY, BUT WAS CANCELLED DUE TO SURGEON'S CONCERN FOR POSSIBILITY OF INFECTION (REMOTE POSSIBILITY).

BRAND NAME

WHITACRE NEEDLE

TYPE OF DEVICE

SPINAL NEEDLE, 27 G 3 1/2"

MANUFACTURER (Section D)

DEVICE EVENT KEY

34164

MDR REPORT KEY

32864

EVENT KEY

30867

REPORT NUMBER

32864

DEVICE SEQUENCE NUMBER

1

PRODUCT CODE

BSP

REPORT SOURCE

VOLUNTARY

REPORT DATE

04/30/1996

1 DEVICE WAS INVOLVED IN THE EVENT

1 PATIENT WAS INVOLVED IN THE EVENT

DATE FDA RECEIVED

05/10/1996

IS THIS AN ADVERSE EVENT REPORT?

NO

IS THIS A PRODUCT PROBLEM REPORT?

YES

DEVICE OPERATOR

HEALTH PROFESSIONAL

DEVICE MODEL NUMBER

405079

DEVICE CATALOGUE NUMBER

405079

DEVICE LOT NUMBER

6A928

WAS DEVICE AVAILABLE FOR EVALUATION?

YES

ADVERSE EVENT OR PRODUCT PROBLEM DESCRIPTION

REPORT DATE: 04/30/1996  MDR TEXT KEY: 46036 Patient Sequence Number: 1

FOREIGN MATERIAL ATTACHED TO STYLET AT THE HUB/BASE AREA. ANESTHESIOLOGIST NOTED IT AFTER PLACING NEEDLE INTO PT.

BRAND NAME

WHITACRE SPINAL NEEDLE

TYPE OF DEVICE

SPINAL NEEDLE

MANUFACTURER (Section F)

MANUFACTURER (Section D)

DEVICE EVENT KEY

31738

MDR REPORT KEY

30678

EVENT KEY

28764

REPORT NUMBER

30678

DEVICE SEQUENCE NUMBER

1

PRODUCT CODE

BSP

REPORT SOURCE

USER FACILITY

TYPE OF REPORT

INITIAL

REPORT DATE

10/17/1995

1 DEVICE WAS INVOLVED IN THE EVENT

1 PATIENT WAS INVOLVED IN THE EVENT

DATE FDA RECEIVED

01/26/1996

IS THIS AN ADVERSE EVENT REPORT?

NO

IS THIS A PRODUCT PROBLEM REPORT?

YES

DEVICE OPERATOR

HEALTH PROFESSIONAL

DEVICE CATALOGUE NUMBER

405079

DEVICE LOT NUMBER

4J914

WAS DEVICE AVAILABLE FOR EVALUATION?

NO

IS THE REPORTER A HEALTH PROFESSIONAL?

YES

WAS THE REPORT SENT TO FDA?

NO

DISTRIBUTOR FACILITY AWARE DATE

10/11/1995

EVENT LOCATION

HOSPITAL

DATE REPORT TO MANUFACTURER

10/17/1995

PATIENT OUTCOME

REQUIRED INTERVENTION 

ADVERSE EVENT OR PRODUCT PROBLEM DESCRIPTION

REPORT DATE: 10/17/1995  MDR TEXT KEY: 42370 Patient Sequence Number: 1

A 27 GAUGE 3-1/2" NEEDLE BROKE DURING AN ATTEMPTED SPINAL ANESTHESIA. ONE AND ONE HALF INCHES OF THE NEEDLE REMAINED IMBEDDED AND HAD TO BE SURGICALLY REMOVED. INITIAL SKIN PUNCTURE WAS MADE WITH A 17 GAUGE NEEDLE.

BRAND NAME

B-D WHITACRE NEEDLE, 22 G, 3 1/2

MANUFACTURER (Section D)

DEVICE EVENT KEY

14747

MDR REPORT KEY

14753

EVENT KEY

11539

REPORT NUMBER

14753

DEVICE SEQUENCE NUMBER

1

PRODUCT CODE

BSO

REPORT SOURCE

VOLUNTARY

REPORT DATE

07/05/1994

1 DEVICE WAS INVOLVED IN THE EVENT

1 PATIENT WAS INVOLVED IN THE EVENT

DATE FDA RECEIVED

07/19/1994

IS THIS AN ADVERSE EVENT REPORT?

NO

DEVICE OPERATOR

INVALID DATA

DEVICE CATALOGUE NUMBER

405010

DEVICE LOT NUMBER

3A390

WAS DEVICE AVAILABLE FOR EVALUATION?

YES

ADVERSE EVENT OR PRODUCT PROBLEM DESCRIPTION

REPORT DATE:   MDR TEXT KEY: 14891 Patient Sequence Number: 1

STEEL NEEDLE BECAME DETACHED FROM PLASTIC LUER-LOK HUB AT CEMENTED FITTING. NO ABNORMAL USAGE OR TORQUE APPLIED. NO EVIDENT PACKAGE DAMAGE. COULD RESULT IN RETAINED, IMBEDDED NEEDLE IN PT. ENTIRE NEEDLE, HUB, AND STYLET AVAILABLE. OTHER NEEDLES FROM SAME LOT WITHIN FACILITY INSPECTED AND NO SIMILAR DESCRIPTION NOTED.