BRAND NAME

SPROTTE SPINAL TRAY

TYPE OF DEVICE

SPINAL NEEDLE

MANUFACTURER (Section F)

MANUFACTURER (Section D)

DEVICE EVENT KEY

404417

MDR REPORT KEY

415379

EVENT KEY

392807

REPORT NUMBER

415379

DEVICE SEQUENCE NUMBER

1

PRODUCT CODE

BSP

REPORT SOURCE

USER FACILITY

TYPE OF REPORT

INITIAL

REPORT DATE

08/30/2002

1 DEVICE WAS INVOLVED IN THE EVENT

1 PATIENT WAS INVOLVED IN THE EVENT

DATE FDA RECEIVED

09/04/2002

IS THIS AN ADVERSE EVENT REPORT?

YES

IS THIS A PRODUCT PROBLEM REPORT?

YES

DEVICE OPERATOR

HEALTH PROFESSIONAL

DEVICE EXPIRATION DATE

11/01/2003

DEVICE MODEL NUMBER

SP25BK

DEVICE CATALOGUE NUMBER

333750

DEVICE LOT NUMBER

60315313 200 3-11

WAS DEVICE AVAILABLE FOR EVALUATION?

DEVICE NOT RETURNED TO MANUFACTURER

DATE RETURNED TO MANUFACTURER

08/30/2002

IS THE REPORTER A HEALTH PROFESSIONAL?

YES

WAS THE REPORT SENT TO FDA?

YES

DATE REPORT TO FDA

08/12/2002

DISTRIBUTOR FACILITY AWARE DATE

07/17/2002

EVENT LOCATION

HOSPITAL

DATE REPORT TO MANUFACTURER

07/17/2002

PATIENT OUTCOME

REQUIRED INTERVENTION 

ADVERSE EVENT OR PRODUCT PROBLEM DESCRIPTION

REPORT DATE: 08/30/2002  MDR TEXT KEY: 1442849 Patient Sequence Number: 1

PT WAS UNDERGOING REPAIR OF INCISIONAL HERNIA UNDER SPINAL BLOCK AT L4-5. BETADINE PREP, 1% LIDO INTRODUCER NEEDLE PLACED. 25G SPROTTE NEEDLE PLACED WITHOUT CSF. WHEN NEEDLE WAS WITHDRAWN, HALF OF NEEDLE WAS LEFT IN PT. RETAINED PORTION OF NEEDLE WAS REMOVED WITH FLUOROSCOPY.

BRAND NAME

SPROTTE SPINAL NEEDLE TRAY

TYPE OF DEVICE

SPINAL NEEDLE TRAY

BASELINE BRAND NAME

SPROTTE SPINAL NEEDLE TRAY

BASELINE GENERIC NAME

SPINAL NEEDLE KIT

BASELINE CATALOGUE NUMBER

333750

BASELINE MODEL NUMBER

SP25BK

BASELINE DEVICE FAMILY

SPINAL NEEDLE KIT

BASELINE DEVICE 510(K) NUMBER

K932569

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

01/26/1994

MANUFACTURER (Section F)

MANUFACTURER (Section D)

MANUFACTURER CONTACT

DEVICE EVENT KEY

400665

MDR REPORT KEY

411652

EVENT KEY

389224

REPORT NUMBER

2523676-2002-00045

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

08/09/2002

1 DEVICE WAS INVOLVED IN THE EVENT

1 PATIENT WAS INVOLVED IN THE EVENT

DATE FDA RECEIVED

08/19/2002

IS THIS AN ADVERSE EVENT REPORT?

YES

IS THIS A PRODUCT PROBLEM REPORT?

NO

DEVICE OPERATOR

HEALTH PROFESSIONAL

DEVICE EXPIRATION DATE

11/30/2003

DEVICE MODEL NUMBER

SP25BK

DEVICE CATALOGUE NUMBER

333750

WAS DEVICE AVAILABLE FOR EVALUATION?

YES

IS THE REPORTER A HEALTH PROFESSIONAL?

YES

WAS THE REPORT SENT TO FDA?

NO

DISTRIBUTOR FACILITY AWARE DATE

07/17/2002

DEVICE AGE

UNKNOWN

EVENT LOCATION

HOSPITAL

DATE MANUFACTURER RECEIVED

07/17/2002

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 

ADDITIONAL MANUFACTURER NARRATIVE

REPORT DATE: 08/09/2002  MDR TEXT KEY: 1430300 

THE ACTUAL SAMPLE HAS NOT YET BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. BASED ON THE INFORMATION PROVIDED, NO SPECIFIC CONCLUSIONS CAN BE DRAWN. IF APPLICABLE, A FOLLOW UP REPORT WILL BE FILED WHEN THE SAMPLE IS RETURNED.

ADVERSE EVENT OR PRODUCT PROBLEM DESCRIPTION

REPORT DATE: 08/09/2002  MDR TEXT KEY: 1430297 Patient Sequence Number: 1

USER FACILITY REPORTS THE FOLLOWING: OBESE PATIENT UNDERGOING UMBILICAL REPAIR. SPINAL NEEDLE WAS INTRODUCED THROUGH INTRODUCER AND DOCTOR DETERMINED HE HAD NOT ENTERED SUBARACHNOID SPACE AND DECIDED TO WITHDRAW NEEDLE TO REPOSITION. DURING WITHDRAWAL OF SPINAL NEEDLE, NEEDLE BROKE APPROXIMATELY IN HALF, DISTAL HALF REMAINING IN PATIENT. THE FRAGMENT WAS SURGICALLY REMOVED. ACCORDING TO DOCTOR, THE PATIENT IS DOING WELL.

BRAND NAME

SPROTTE SPINAL NEEDLE TRAY

TYPE OF DEVICE

ANESTHESIA AGENT - SPINAL NEEDLE TRAY

MANUFACTURER (Section D)

DEVICE EVENT KEY

391600

MDR REPORT KEY

402591

EVENT KEY

380478

REPORT NUMBER

402591

DEVICE SEQUENCE NUMBER

1

PRODUCT CODE

CAZ

REPORT SOURCE

VOLUNTARY

REPORT DATE

06/20/2002

1 DEVICE WAS INVOLVED IN THE EVENT

1 PATIENT WAS INVOLVED IN THE EVENT

DATE FDA RECEIVED

06/26/2002

IS THIS AN ADVERSE EVENT REPORT?

NO

IS THIS A PRODUCT PROBLEM REPORT?

YES

DEVICE OPERATOR

HEALTH PROFESSIONAL

DEVICE EXPIRATION DATE

11/01/2003

DEVICE LOT NUMBER

60306444

WAS DEVICE AVAILABLE FOR EVALUATION?

NO ANSWER PROVIDED

PATIENT OUTCOME

OTHER 

ADVERSE EVENT OR PRODUCT PROBLEM DESCRIPTION

REPORT DATE: 06/20/2002  MDR TEXT KEY: 1398498 Patient Sequence Number: 1

PT SCHEDULED TO UNDERGO TOTAL KNEE REPLACEMENT WITH SPINAL ANESTHESIA. GOOD SPINAL TAP, NO RESULTS WITH ANESTHETIC AGENT. PT CONVERTED TO GENERAL ANESTHESIA DUE TO FAILED SPINAL.

BRAND NAME

SPROTTE

TYPE OF DEVICE

SPINAL NEEDLE

BASELINE BRAND NAME

SPROTTE

BASELINE GENERIC NAME

SPINAL NEEDLE

BASELINE CATALOGUE NUMBER

333769

BASELINE MODEL NUMBER

SP27123

BASELINE DEVICE FAMILY

SPINAL NEEDLE

BASELINE DEVICE 510(K) NUMBER

K932569

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

01/26/1994

MANUFACTURER (Section F)

MANUFACTURER (Section D)

MANUFACTURER CONTACT

DEVICE EVENT KEY

351455

MDR REPORT KEY

362312

EVENT KEY

341566

REPORT NUMBER

2523676-2001-00055

DEVICE SEQUENCE NUMBER

1

PRODUCT CODE

BSP

REPORT SOURCE

MANUFACTURER

SOURCE TYPE

USER FACILITY

REMEDIAL ACTION

OTHER

EVENT TYPE

INJURY

TYPE OF REPORT

INITIAL

REPORT DATE

11/14/2001

1 DEVICE WAS INVOLVED IN THE EVENT

1 PATIENT WAS INVOLVED IN THE EVENT

DATE FDA RECEIVED

11/19/2001

IS THIS AN ADVERSE EVENT REPORT?

YES

IS THIS A PRODUCT PROBLEM REPORT?

NO

DEVICE OPERATOR

HEALTH PROFESSIONAL

DEVICE MODEL NUMBER

SP27123

DEVICE CATALOGUE NUMBER

333769

DEVICE LOT NUMBER

60083531

WAS DEVICE AVAILABLE FOR EVALUATION?

YES

IS THE REPORTER A HEALTH PROFESSIONAL?

YES

WAS THE REPORT SENT TO FDA?

NO

DISTRIBUTOR FACILITY AWARE DATE

10/19/2001

DEVICE AGE

1.5 YR

EVENT LOCATION

HOSPITAL

DATE MANUFACTURER RECEIVED

10/22/2001

WAS DEVICE EVALUATED BY MANUFACTURER?

YES

DATE DEVICE MANUFACTURED

03/01/2000

IS THE DEVICE SINGLE USE?

YES

TYPE OF DEVICE USAGE

INITIAL

PATIENT OUTCOME

OTHER 

ADVERSE EVENT OR PRODUCT PROBLEM DESCRIPTION

REPORT DATE: 11/14/2001  MDR TEXT KEY: 1258947 Patient Sequence Number: 1

THE USER FACILITY REPORTED THE FOLLOWING: "PERFORMING SPINAL ANESTHESIA ON A PT TWO ATTEMPTS AT ADVANCEMENT OF NEEDLE RESISTANCE WAS FELT. ON THIRD ATTEMPT TO ADVANCE NEEDLE, APPROX 1/2 INCH OF DISTAL END OF NEEDLE BROKE OFF. UNABLE TO REMOVE FRAGMENT IN PERI-SPINOUS MUSCLE. SCHEDULED PROCEDURE WAS COMPLETED WITHOUT FURTHER INCIDENT."

ADDITIONAL MANUFACTURER NARRATIVE

REPORT DATE: 11/19/2001  MDR TEXT KEY: 1258950 

ONE USED SPINAL NEEDLE WAS RETURNED FOR EVAL. APPROX 14MM OF THE UNSHEATHED NEEDLE WAS MISSING. THE NEEDLE LENGTH MEASURED 109MM (SPECIFICATION IS 123MM +/- 1MM). INFO PROVIDED BY THE USER FACILITY INDICATES THAT RESISTANCE WAS FELT DURING INSERTION IN PT. IN ADDITION THE APPEARANCE OF THE BREAK SUGGESTS THAT THE NEEDLE WAS BENT BEYOND ITS INTENDED DESIGN CAPABILITIES WHICH CAUSED IT TO BREAK. THERE WAS NO INDICATION THAT THIS OCCURRENCE WAS THE RESULT OF THE PRODUCT MALFUNCTION. NO FURTHER INFO IS AVAILABLE ON THE PT'S STATUS.

BRAND NAME

SPINAL 24G SPROTTE

TYPE OF DEVICE

REGIONAL ANESTHESIA TRAY

BASELINE BRAND NAME

SPINAL 24G SPROTTE

BASELINE GENERIC NAME

REGIONAL ANESTHESIA TRAY

BASELINE CATALOGUE NUMBER

15858

MANUFACTURER (Section F)

MANUFACTURER (Section D)

MANUFACTURER (Section G)

MANUFACTURER CONTACT

DEVICE EVENT KEY

329218

MDR REPORT KEY

339894

EVENT KEY

320010

REPORT NUMBER

1018381-2001-00050

DEVICE SEQUENCE NUMBER

1

PRODUCT CODE

CAZ

REPORT SOURCE

MANUFACTURER

SOURCE TYPE

HEALTH PROFESSIONAL

EVENT TYPE

INJURY

TYPE OF REPORT

INITIAL,FOLLOWUP

REPORT DATE

05/24/2001

1 DEVICE WAS INVOLVED IN THE EVENT

1 PATIENT WAS INVOLVED IN THE EVENT

DATE FDA RECEIVED

06/29/2001

IS THIS AN ADVERSE EVENT REPORT?

YES

IS THIS A PRODUCT PROBLEM REPORT?

NO

DEVICE OPERATOR

HEALTH PROFESSIONAL

DEVICE CATALOGUE NUMBER

15858

DEVICE LOT NUMBER

66-571-Z1

WAS DEVICE AVAILABLE FOR EVALUATION?

NO

IS THE REPORTER A HEALTH PROFESSIONAL?

YES

WAS THE REPORT SENT TO FDA?

NO

DATE MANUFACTURER RECEIVED

05/24/2001

WAS DEVICE EVALUATED BY MANUFACTURER?

NO

DATE DEVICE MANUFACTURED

06/01/2000

IS THE DEVICE SINGLE USE?

YES

TYPE OF DEVICE USAGE

INITIAL

PATIENT OUTCOME

REQUIRED INTERVENTION 

ADVERSE EVENT OR PRODUCT PROBLEM DESCRIPTION

REPORT DATE: 05/24/2001  MDR TEXT KEY: 1176126 Patient Sequence Number: 1

REPORT RECEIVED OF A SPINAL NEEDLE BREAK DURING A C-SECTION PROCEDURE. THE CUSTOMER REPORTS THAT THE PT WAS IN THE OPERATING ROOM FOR A C-SECTION "WHEN THE SPROTTE NEEDLE BROKE OFF." THE PT WAS REPORTED TO BE "DOING FINE." THERE WAS NO REPORT OF ANY ADVERSE PT EFFECT. MULTIPLE ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE, BUT NO FURTHER INFO WAS RECEIVED.

ADDITIONAL MANUFACTURER NARRATIVE

REPORT DATE: 06/29/2001  MDR TEXT KEY: 1176129 

THE DEVICE IS EXPECTED TO BE RETURNED FOR TESTING AND INVESTIGATION. IT HAS NOT YET BEEN RECEIVED. THIS REPORT REPRESENTS ALL THE INFO KNOWN BY THE RPTR UPON QUERY BY ABBOTT PERSONNEL.

ADDITIONAL MANUFACTURER NARRATIVE

REPORT DATE: 05/24/2001  MDR TEXT KEY: 1500411 

IT WAS INITIALLY REPORTED THAT THE USED DEVICE WOULD BE RETURNED FOR ANALYSIS. HOWEVER, THE ACTUAL DEVICE INVOLVED IN THE REPORTED INCIDENT WAS NOT RECD. WE WERE UNABLE TO CONFIRM THE REPORTED INCIDENT DURING VISUAL EXAMINATION OF THE FILE SAMPLE FROM THE INVOLVED LOT NUMBER. A REVIEW OF THE BATCH RECORD REVEALED THE LOT MET PRODUCT SPECIFICATION REQUIREMENT. A REVIEW OF OUR PRODUCT SURVEILLANCE FILES REVEALED THIS LOT NUMBER RECD NO OTHER SIMILAR REPORTS.

BRAND NAME

SPROTTE

TYPE OF DEVICE

SPINAL NEEDLE

MANUFACTURER (Section D)

DEVICE EVENT KEY

248763

MDR REPORT KEY

256886

EVENT KEY

240773

REPORT NUMBER

256886

DEVICE SEQUENCE NUMBER

1

PRODUCT CODE

BSP

REPORT SOURCE

VOLUNTARY

REPORT DATE

12/17/1999

1 DEVICE WAS INVOLVED IN THE EVENT

1 PATIENT WAS INVOLVED IN THE EVENT

DATE FDA RECEIVED

12/17/1999

IS THIS AN ADVERSE EVENT REPORT?

NO

IS THIS A PRODUCT PROBLEM REPORT?

YES

DEVICE OPERATOR

HEALTH PROFESSIONAL

DEVICE LOT NUMBER

60044070

OTHER DEVICE ID NUMBER

2001-02

WAS DEVICE AVAILABLE FOR EVALUATION?

DEVICE NOT RETURNED TO MANUFACTURER

DATE RETURNED TO MANUFACTURER

12/15/1999

PATIENT OUTCOME

OTHER 

ADVERSE EVENT OR PRODUCT PROBLEM DESCRIPTION

REPORT DATE: 12/17/1999  MDR TEXT KEY: 871368 Patient Sequence Number: 1

SPINAL ANESTHESIA BEING ATTEMPTED IN PREPARATION FOR ARTHROSCOPY OF LEFT ANKLE. PT SLIGHTLY UNCOOPERATIVE, RAISING UP AND MOVING WITH THE SLIGHTEST TOUCH TO BACK.

BRAND NAME

SPROTTE PENCIL POINT SPINAL NEEDLE (WITHOUT INTRODUCER)

TYPE OF DEVICE

SPINAL NEEDLE

BASELINE BRAND NAME

SPROTTE PENCIL POINT SPINAL NEEDLE

BASELINE GENERIC NAME

SPINAL NEEDLE

BASELINE CATALOGUE NUMBER

03115130A

BASELINE DEVICE FAMILY

EPIDURAL NEEDLE

BASELINE DEVICE 510(K) NUMBER

K911260

BASELINE SHELF LIFE INFORMATION

*

IS BASELINE PMA NUMBER PROVIDED?</< TH>

NO

BASELINE PREAMENDMENT?

NO

TRANSITIONAL?

NO

510(K) EXEMPT?

NO

MANUFACTURER (Section F)

MANUFACTURER (Section D)

MANUFACTURER (Section G)

MANUFACTURER CONTACT

DEVICE EVENT KEY

223213

MDR REPORT KEY

230157

EVENT KEY

216058

REPORT NUMBER

2429473-1999-00058

DEVICE SEQUENCE NUMBER

1

PRODUCT CODE

GDM

REPORT SOURCE

MANUFACTURER

SOURCE TYPE

USER FACILITY

EVENT TYPE

INJURY

TYPE OF REPORT

INITIAL,FOLLOWUP

REPORT DATE

06/29/1999

1 DEVICE WAS INVOLVED IN THE EVENT

1 PATIENT WAS INVOLVED IN THE EVENT

DATE FDA RECEIVED

07/01/1999

IS THIS AN ADVERSE EVENT REPORT?

YES

IS THIS A PRODUCT PROBLEM REPORT?

YES

DEVICE OPERATOR

HEALTH PROFESSIONAL

DEVICE CATALOGUE NUMBER

03115130A

WAS DEVICE AVAILABLE FOR EVALUATION?

YES

IS THE REPORTER A HEALTH PROFESSIONAL?

UNKNOWN

WAS THE REPORT SENT TO FDA?

NO

DATE MANUFACTURER RECEIVED

06/17/1999

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: 06/29/1999  MDR TEXT KEY: 767910 Patient Sequence Number: 1

IT WAS REPORTED THAT THE PT WAS UNDERGOING AN ELECTIVE CESAREAN SECTION UNDER SPINAL BLOCK ANESTHESIA. AN INTRODUCER WAS PLACED, AND THEN THE SPROTTE NEEDLE WAS PLACED. SPINAL FLUID WAS NOT OBTAINED; THE INTRODUCER AND NEEDLE WERE REMOVED. UPON REMOVAL, IT WAS NOTED THAT THE DISTAL PORTION OF THE NEEDLE WAS NOT REMOVED. AFTER THE PROCEDURE, THE PT UNDERWENT AN ADD'L PROCEDURE TO REMOVE THE TIP. NO FURTHER CONSEQUENCES WERE NOTED.

ADDITIONAL MANUFACTURER NARRATIVE

REPORT DATE: 06/29/1999  MDR TEXT KEY: 767913 

DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN.

ADDITIONAL MANUFACTURER NARRATIVE

REPORT DATE: 06/29/1999  MDR TEXT KEY: 787394 

DEVICE EVAL NOT POSSIBLE, AS ALLEGEDLY DEFECTIVE DEVICE HAS NOT BEEN RETURNED FOR MFR'S INVESTIGATION.

BRAND NAME

SPROTTE PENCIL POINT SPINAL NEEDLE

TYPE OF DEVICE

SPINAL NEEDLE

BASELINE BRAND NAME

SPROTTE PENCIL POINT SPINAL NEEDLE

BASELINE GENERIC NAME

SPROTTE NEEDLE

BASELINE CATALOGUE NUMBER

00115130A

BASELINE DEVICE FAMILY

SPROTTE, TUOHY NEEDLE

BASELINE DEVICE 510(K) NUMBER

K911260

BASELINE SHELF LIFE INFORMATION

*

IS BASELINE PMA NUMBER PROVIDED?</< TH>

NO

BASELINE PREAMENDMENT?

NO

TRANSITIONAL?

NO

510(K) EXEMPT?

NO

MANUFACTURER (Section G)

MANUFACTURER CONTACT

DEVICE EVENT KEY

85965

MDR REPORT KEY

90315

EVENT KEY

81654

REPORT NUMBER

2429473-1997-00045

DEVICE SEQUENCE NUMBER

1

PRODUCT CODE

BSP

REPORT SOURCE

MANUFACTURER

SOURCE TYPE

USER FACILITY

EVENT TYPE

INJURY

TYPE OF REPORT

INITIAL

1 DEVICE WAS INVOLVED IN THE EVENT

1 PATIENT WAS INVOLVED IN THE EVENT

DATE FDA RECEIVED

05/09/1997

IS THIS AN ADVERSE EVENT REPORT?

NO

DEVICE OPERATOR

HEALTH PROFESSIONAL

DEVICE CATALOGUE NUMBER

00115130A

DEVICE LOT NUMBER

299

WAS DEVICE AVAILABLE FOR EVALUATION?

YES

DATE MANUFACTURER RECEIVED

05/08/1997

WAS DEVICE EVALUATED BY MANUFACTURER?

NO

IS THE DEVICE SINGLE USE?

NO ANSWER PROVIDED

TYPE OF DEVICE USAGE

UNKNOWN

BRAND NAME

SPROTTE SPINAL NEEDLE

TYPE OF DEVICE

SPINAL NEEDLE

BASELINE BRAND NAME

SPROTTE PENCIL POINT SPINAL NEEDLE

BASELINE GENERIC NAME

SPROTTE NEEDLE

BASELINE CATALOGUE NUMBER

00115130A

BASELINE DEVICE FAMILY

SPROTTE, TUOHY NEEDLE

BASELINE DEVICE 510(K) NUMBER

K911260

BASELINE SHELF LIFE INFORMATION