BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES
Report
- Report Number
- 3003916417-2025-00005
- Event Type
- Malfunction
- Date Received
- January 23, 2025
- Date of Event
- December 27, 2024
- Report Date
- May 23, 2025
- Manufacturer
- BECTON DICKINSON IND. CIRURGICAS LTDA
- Product Code
- JKA
- UDI-DI
- 30382903600602
- PMA / PMN Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
INVESTIGATION SUMMARY BD HAD NOT RECEIVED SAMPLES, BUT 19 PHOTOS WERE PROVIDED FOR INVESTIGATION. THE PHOTOS WERE REVIEWED AND THE INDICATED FAILURE MODES FOR ADDITIVE ABNORMALITY, POOR BARRIER SEPARATION, AND POOR SERUM WAS OBSERVED. IN ADDITION, IT IS NOTED THAT THE PHOTOS PROVIDED BATCH VERIFICATION FOR LOT# 4088554. ADDITIONALLY, 200 RETENTION SAMPLES FROM BD INVENTORY FOR LOTS 4088544 AND 4150231 WERE VISUALLY INSPECTED AND NO ISSUES WERE OBSERVED. RETAINS FOR LOT # 4088554 WERE NOT INSPECTED SINCE THE DEFECTS WERE CONFIRMED THROUGH PHOTOGRAPHIC EVIDENCE SHOWING BATCH VERIFICATION. COMPLAINTS FOR SAMPLE QUALITY ARE UNDER STATISTICAL CONTROL FOR THE MONTH OF DECEMBER 2024. AT THIS TIME, FURTHER TESTING IS NOT INDICATED. BASED ON A REVIEW OF THE DEVICE HISTORY RECORD FOR THE INCIDENT LOT, ALL PRODUCT SPECIFICATIONS AND REQUIREMENTS FOR LOT RELEASE WERE MET. THERE WERE NO RELATED QUALITY ISSUES DURING MANUFACTURING OF THE PRODUCT. THIS COMPLAINT HAS BEEN CONFIRMED FOR THE INDICATED FAILURE MODES ADDITIVE ABNORMALITY, POOR BARRIER SEPARATION, AND POOR SERUM BASED ON THE PHOTOS PROVIDED. BD WAS NOT ABLE TO IDENTIFY A ROOT CAUSE FOR THE INDICATED FAILURE MODE. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS. BD QUALITY WILL CONTINUE TO MONITOR SAMPLE QUALITY COMPLAINTS.
THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH ADDITIONAL LOT NUMBER IS AS FOLLOWS: D4. MEDICAL DEVICE LOT #:4150231. D4. MEDICAL DEVICE EXPIRATION DATE: 31-MAY-2025. H4. DEVICE MANUFACTURE DATE: 02-JUL-2024. D4. UNIQUE IDENTIFIER (UDI) #: (B)(4). D4. MEDICAL DEVICE LOT #:4088544. D4. MEDICAL DEVICE EXPIRATION DATE: 31-MAR-2025. H4. DEVICE MANUFACTURE DATE: 22-APR-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 DURING USE OF BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES, AN UNSPECIFIED NUMBER OF TUBES ARE EXHIBITING ADDITIVE ABNORMALITY (MICRONIZED SILICON PARTICLES ON THE TUBE WALLS), AND PATIENT SAMPLES ARE EXHIBITING POOR SERUM (WALLS OF TUBES ARE STAINED RED) AND AFTER PROCESSING/CENTRIFUGATION POOR BARRIER SEPARATION IS OBSERVED WITH EXCESS RBC'S ON GEL LAYER. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.
IT WAS REPORTED DURING USE OF BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES, AN UNSPECIFIED NUMBER OF TUBES ARE EXHIBITING ADDITIVE ABNORMALITY (MICRONIZED SILICON PARTICLES ON THE TUBE WALLS), AND PATIENT SAMPLES ARE EXHIBITING POOR SERUM (WALLS OF TUBES ARE STAINED RED) AND AFTER PROCESSING/CENTRIFUGATION POOR BARRIER SEPARATION IS OBSERVED WITH EXCESS RBC'S ON GEL LAYER. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 420350 | BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES | TUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION | JKA | BECTON DICKINSON IND. CIRURGICAS LTDA | 4088554 | 30382903600602 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |