BD VACUTAINER® SST¿ II ADVANCE PLUS BLOOD COLLECTION TUBES
Report
- Report Number
- 9617032-2025-00139
- Event Type
- Malfunction
- Date Received
- February 11, 2025
- Date of Event
- January 15, 2025
- Report Date
- June 27, 2025
- Manufacturer
- BECTON, DICKINSON AND COMPANY (BD)
- Product Code
- JKA
- UDI-DI
- 30382903668800
- PMA / PMN Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
THE FOLLOWING FIELDS HAVE BEEN UPDATED WITH CORRECTED AND/OR ADDITIONAL INFORMATION. D9: DEVICE AVAILABLE FOR EVALUATION: YES. H3: DEVICE EVAL BY MANUFACTURER? YES. D9: RETURNED TO MANUFACTURER ON: 11-FEB-2025. INVESTIGATION SUMMARY: BD RECEIVED FOUR PHOTOS AND FIVE SAMPLES FOR INVESTIGATION. THE SAMPLES INCLUDED ONE FROM LOT NUMBER: 4152060, ONE FROM LOT NUMBER 4198930, AND THREE FROM LOT NUMBER: 4241835. EVALUATION OF THE PHOTOS REVEALED FIBRIN AND RED CELL HANG-UP IN THE SERUM. ALL RETURNED SAMPLES WERE INVESTIGATED, AND NO ADDITIVE DEFECTS RELATED TO FIBRIN OR RED CELL HANG-UP WERE IDENTIFIED. ADDITIONALLY, 100 RETAINED SAMPLES FROM EACH LOT NUMBER: 4241835, 4152060, AND 4198930 WERE VISUALLY INSPECTED, AND NO ADDITIVE DEFECTS WERE FOUND. COMPLAINTS FOR SAMPLE QUALITY WERE NOT UNDER STATISTICAL CONTROL FOR THE MONTH OF JANUARY 2025; ADDITIONAL TESTING WAS PERFORMED. THERE WERE NO DIFFICULTIES ENCOUNTERED DURING BLOOD COLLECTION AND ALL TUBES EXHIBITED PROPER FILL. BD WAS UNABLE TO DUPLICATE THE CUSTOMER¿S INDICATED FAILURE MODE (FIBRIN, RED CELL HANG UP) VIA CLINICAL INVESTIGATION BECAUSE THE DEFECTS WERE NOT EVIDENT IN THE TESTING OF THE COMPLAINT LOT SAMPLES. ALL VISUAL OBSERVATIONS OF BOTH RETENTION AND CONTROL SAMPLES DEMONSTRATED CLINICALLY ACCEPTABLE PERFORMANCE. 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 INDICATED FAILURE MODE: FIBRIN AND RED CELL HANG-UP BASED ON THE PHOTOS PROVIDED. A CORRECTIVE AND PREVENTIVE ACTION (CAPA) HAS BEEN OPENED FOR SAMPLE QUALITY ISSUES. 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. BD QUALITY WILL CONTINUE TO MONITOR SAMPLE QUALITY COMPLAINTS.
B3: DATE OF EVENT IS UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH ADDITIONAL LOT NUMBER IS AS FOLLOWS: D4. MEDICAL DEVICE LOT #: 4241835 D4. MEDICAL DEVICE EXPIRATION DATE: 28-FEB-2026 H4. DEVICE MANUFACTURE DATE: 28-AUG-2024 D4. UNIQUE IDENTIFIER (UDI) #: (B)(4). D4. MEDICAL DEVICE LOT #: 4152060 D4. MEDICAL DEVICE EXPIRATION DATE: 30-NOV-2025 H4. DEVICE MANUFACTURE DATE: 31-MAY-2024 D4. UNIQUE IDENTIFIER (UDI) #:(B)(4). 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 WHILE USING BD VACUTAINER® SST¿ II ADVANCE PLUS BLOOD COLLECTION TUBES, AN UNSPECIFIED NUMBER OF TUBES EXHIBIT FIBRIN AND RED CELL HANG UP AFTER CENTRIFUGATION. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.
IT WAS REPORTED WHILE USING BD VACUTAINER® SST¿ II ADVANCE PLUS BLOOD COLLECTION TUBES, AN UNSPECIFIED NUMBER OF TUBES EXHIBIT FIBRIN AND RED CELL HANG UP AFTER CENTRIFUGATION. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 856959 | BD VACUTAINER® SST¿ II ADVANCE PLUS BLOOD COLLECTION TUBES | TUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION | JKA | BECTON, DICKINSON AND COMPANY (BD) | 4198930 | 30382903668800 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |