BD VACUTAINER® SST¿ II ADVANCE PLUS BLOOD COLLECTION TUBES
Report
- Report Number
- 9617032-2022-00726
- Event Type
- Malfunction
- Date Received
- August 8, 2022
- Date of Event
- July 12, 2022
- Report Date
- August 25, 2022
- Manufacturer
- BECTON, DICKINSON AND COMPANY (BD)
- Product Code
- JKA
- PMA / PMN Number
- BK050036
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD.
H.6 INVESTIGATION SUMMARY BD RECEIVED 20 SAMPLES (LOT 2094470) AND A PHOTOGRAPH FROM THE CUSTOMER IN SUPPORT OF THIS COMPLAINT. 20 RETURNED SAMPLES (LOT 2094470) WERE VISUALLY EVALUATED, NO ADDITIVE ABNORMALITY WAS FOUND. SILICA SPRAY PATTERN WAS SATISFACTORY. ONE PHOTOGRAPH WAS ATTACHED SHOWING 6 TUBES AFTER CENTRIFUGATION. WHILE OBSERVING THE PHOTOGRAPH IT WAS NOTED THAT 4TH TUBE FROM THE LEFT HAD A POOR BARRIER SEPARATION, PART OF THE GEL WAS VISIBLE AT THE BOTTOM OF THE TUBE AND ANOTHER PART OF GEL WAS OBSERVED ON THE TOP OF RED BLOOD CELLS. ADDITIONALLY 100 RETAINED SAMPLES FROM EACH LOT NUMBER: 2094470 AND 2013379 WERE TAKEN AND VISUALLY INSPECTED. SILICA SPRAY PATTERN WAS FOUND TO BE SATISFACTORY. BD WAS ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE MODE BECAUSE THE DEFECT ¿ POOR BARRIER SEPARATION WAS EVIDENT IN THE ATTACHED PHOTOGRAPH. ADDITIVE ABNORMALITY WAS NOT OBSERVED IN THE RETURNED SAMPLES OR RETAINED SAMPLES AND WAS THEREFORE NOT CONFIRMED. CUSTOMER STATED THAT THE ISSUE WAS FOUND TO BE CENTRIFUGE PROGRAMMING. THE DEVICE HISTORY RECORDS WERE REVIEWED WITH NO ISSUES BEING IDENTIFIED. THERE WERE NO RELATED QUALITY NOTIFICATIONS. ALL PROCESS AND FINAL INSPECTIONS COMPLY WITH SPECIFICATION REQUIREMENTS.
THE FOLLOWING FIELDS HAVE BEEN UPDATED: D.4. MEDICAL DEVICE LOT #: 2013379. D.4. MEDICAL DEVICE EXPIRATION DATE: 2023-07-31. H.4. DEVICE MANUFACTURE DATE: 2022-01-13. B.5 DESCRIBE EVENT OR PROBLEM: IT WAS REPORTED BEFORE USING BD VACUTAINER® SST¿ II ADVANCE PLUS BLOOD COLLECTION TUBES ARE "SPOTTED". GEL DOES NOT RISE CORRECTLY. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: I STILL HAVE TUBES AVAILABLE FOR INVESTIGATION IF NEEDED. I AM ATTACHING A PICTURE OF THE TUBES FROM LOT 2094470 THAT WE HAVE ON HAND WE HAVE THE IMPRESSION THAT THE TUBES ARE "SPOTTED" MORE THAN USUAL! WE HAVE SOME PROBLEMS WITH THE DRY GEL TUBES REFERENCE 368498. DURING CENTRIFUGATION, THE GEL DOES NOT RISE CORRECTLY (SEE PICTURE). WE RULED OUT A CENTRIFUGE PROBLEM BECAUSE: -WE HAVE CHECKED OUR CENTRIFUGATION PROGRAMS, THEY ARE CORRECT AND HAVE NOT CHANGED. -IN THE SAME CENTRIFUGATION, SOME TUBES ARE CORRECT AND OTHERS NOT. -THIS PROBLEM CAN APPEAR INDIFFERENTLY ON OUR 2 CENTRIFUGES. D. MEDICAL DEVICE LOT #: 2013379. D.4. MEDICAL DEVICE EXPIRATION DATE: 07/31/2023. H.4. DEVICE MANUFACTURE DATE: 01/13/2022. D.9 DEVICE AVAILABLE FOR EVAL? YES. RETURNED TO MANUFACTURER ON - 5/24/2022.
IT WAS REPORTED BEFORE USING BD VACUTAINER® SST¿ II ADVANCE PLUS BLOOD COLLECTION TUBES ARE "SPOTTED". THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: I STILL HAVE TUBES AVAILABLE FOR INVESTIGATION IF NEEDED. I AM ATTACHING A PICTURE OF THE TUBES FROM LOT 2094470 THAT WE HAVE ON HAND WE HAVE THE IMPRESSION THAT THE TUBES ARE "SPOTTED" MORE THAN USUAL!
IT WAS REPORTED BEFORE USING BD VACUTAINER® SST¿ II ADVANCE PLUS BLOOD COLLECTION TUBES ARE "SPOTTED". GEL DOES NOT RISE CORRECTLY. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: I STILL HAVE TUBES AVAILABLE FOR INVESTIGATION IF NEEDED. I AM ATTACHING A PICTURE OF THE TUBES FROM LOT 2094470 THAT WE HAVE ON HAND WE HAVE THE IMPRESSION THAT THE TUBES ARE "SPOTTED" MORE THAN USUAL! WE HAVE SOME PROBLEMS WITH THE DRY GEL TUBES REFERENCE 368498. DURING CENTRIFUGATION, THE GEL DOES NOT RISE CORRECTLY (SEE PICTURE). WE RULED OUT A CENTRIFUGE PROBLEM BECAUSE: -WE HAVE CHECKED OUR CENTRIFUGATION PROGRAMS, THEY ARE CORRECT AND HAVE NOT CHANGED. -IN THE SAME CENTRIFUGATION, SOME TUBES ARE CORRECT AND OTHERS NOT. -THIS PROBLEM CAN APPEAR INDIFFERENTLY ON OUR 2 CENTRIFUGES.
IT WAS REPORTED BEFORE USING BD VACUTAINER® SST¿ II ADVANCE PLUS BLOOD COLLECTION TUBES ARE "SPOTTED". GEL DOES NOT RISE CORRECTLY. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: I STILL HAVE TUBES AVAILABLE FOR INVESTIGATION IF NEEDED. I AM ATTACHING A PICTURE OF THE TUBES FROM LOT 2094470 THAT WE HAVE ON HAND WE HAVE THE IMPRESSION THAT THE TUBES ARE "SPOTTED" MORE THAN USUAL! WE HAVE SOME PROBLEMS WITH THE DRY GEL TUBES REFERENCE 368498. DURING CENTRIFUGATION, THE GEL DOES NOT RISE CORRECTLY (SEE PICTURE). WE RULED OUT A CENTRIFUGE PROBLEM BECAUSE: -WE HAVE CHECKED OUR CENTRIFUGATION PROGRAMS, THEY ARE CORRECT AND HAVE NOT CHANGED. -IN THE SAME CENTRIFUGATION, SOME TUBES ARE CORRECT AND OTHERS NOT. -THIS PROBLEM CAN APPEAR INDIFFERENTLY ON OUR 2 CENTRIFUGES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2249268 | BD VACUTAINER® SST¿ II ADVANCE PLUS BLOOD COLLECTION TUBES | BLOOD SPECIMEN COLLECTION DEVICE | JKA | BECTON, DICKINSON AND COMPANY (BD) | 2013379 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |