BD VACUTAINER® SAFETY-LOK¿ BLOOD COLLECTION SET PRE-ATTACHED HOLDER
Report
- Report Number
- 1024879-2024-00992
- Event Type
- Malfunction
- Date Received
- November 5, 2024
- Date of Event
- October 7, 2024
- Report Date
- March 6, 2025
- Manufacturer
- BECTON, DICKINSON & CO., (BD)
- Product Code
- JKA
- UDI-DI
- 00382903686544
- PMA / PMN Number
- K980414
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D9: DEVICE AVAILABLE FOR EVALUATION: YES. H.3 DEVICE EVAL BY MANUFACTURER? YES. D9: RETURNED TO MANUFACTURER ON: 15-NOV-2024. INVESTIGATION SUMMARY: BD RECEIVED ONE SAMPLE AND FOUR PHOTOS FOR INVESTIGATION RELATED TO LOT 4193133. THE PHOTOS SHOW SEVERAL DEVICES WITH FOREIGN MATTER ON OR IN THE BLISTER PACK OR SEAL. THE RETURNED SAMPLE PASSED TESTING WITH NO FOREIGN MATTER FOUND ON OR IN THE DEVICE PACKAGING. ADDITIONALLY, 100 RETAINED SAMPLES WERE INSPECTED AND ALL PASSED TESTING WITH NO FOREIGN MATTER FOUND. FOR LOT 4190004, BD RECEIVED FOUR SAMPLES FOR INVESTIGATION. UPON INSPECTION, TWO OF THE FOUR RETURNED SAMPLES FAILED TESTING DUE TO FOREIGN MATTER IN THE DEVICE PACKAGING OR SEAL. ANOTHER 100 RETAINED SAMPLES WERE INSPECTED AND ALL PASSED TESTING WITH NO FOREIGN MATTER FOUND. FOR LOT 4190002, BD RECEIVED ONE SAMPLE FOR INVESTIGATION. THE RETURNED SAMPLE PASSED TESTING WITH NO FOREIGN MATTER FOUND ON OR IN THE DEVICE PACKAGING. ADDITIONALLY, 100 RETAINED SAMPLES WERE INSPECTED AND ALL PASSED TESTING WITH NO FOREIGN MATTER FOUND. BASED ON A REVIEW OF THE DEVICE HISTORY RECORD FOR THE INCIDENT LOTS, ALL PRODUCT SPECIFICATIONS AND REQUIREMENTS FOR LOT RELEASE WERE MET. THIS COMPLAINT HAS BEEN CONFIRMED FOR THE LOTS 4190002, 4190004 AND 4193133, FOR THE INDICATED FAILURE MODE: FOREIGN MATTER - UNKNOWN. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR THE IDENTIFICATION OF EMERGING TRENDS.
THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH ADDITIONAL LOT NUMBER IS AS FOLLOWS: D4. MEDICAL DEVICE LOT#:4190004. D4. MEDICAL DEVICE EXPIRATION DATE: 30-JUN-2026. H4. DEVICE MANUFACTURE DATE: 02-AUG-2024. UNIQUE IDENTIFIER (UDI) #: (B)(4). D4. MEDICAL DEVICE LOT#: 4193133. D4. MEDICAL DEVICE EXPIRATION DATE: 30-JUN-2026. H4. DEVICE MANUFACTURE DATE: 01-AUG-2024. UNIQUE IDENTIFIER (UDI) #:(B)(4). DATE OF EVENT IS UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.
IT WAS REPORTED PRIOR TO USING BD VACUTAINER® SAFETY-LOK¿ BLOOD COLLECTION SET WITH PRE-ATTACHED HOLDER, THERE WERE PARTICLES AND FOREIGN BODIES OBSERVED IN 4 UNITS OF BATCH NUMBER 4190004, AND 1 UNIT FOR EACH BATCH 4193133 AND 4190002. NO PATIENT IMPACT REPORTED.
IT WAS REPORTED PRIOR TO USING BD VACUTAINER® SAFETY-LOK¿ BLOOD COLLECTION SET WITH PRE-ATTACHED HOLDER, THERE WERE PARTICLES AND FOREIGN BODIES OBSERVED IN 4 UNITS OF BATCH NUMBER 4190004, AND 1 UNIT FOR EACH BATCH 4193133 AND 4190002. NO PATIENT IMPACT REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1395951 | BD VACUTAINER® SAFETY-LOK¿ BLOOD COLLECTION SET PRE-ATTACHED HOLDER | TUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION | JKA | BECTON, DICKINSON & CO., (BD) | 4190002 | 00382903686544 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |