BD VACUTAINER® LH PST¿ II PLUS BLOOD COLLECTION TUBES
Report
- Report Number
- 9617032-2023-00351
- Event Type
- Malfunction
- Date Received
- April 5, 2023
- Date of Event
- March 15, 2023
- Report Date
- July 27, 2023
- Manufacturer
- BECTON, DICKINSON AND COMPANY (BD)
- Product Code
- JKA
- PMA / PMN Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
B.3. DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. "MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: D.4. MEDICAL DEVICE LOT #: 2308629, D.4. MEDICAL DEVICE EXPIRATION DATE: 30-APR-2024, H.4. DEVICE MANUFACTURE DATE: 04-NOV-2022; D.4. MEDICAL DEVICE LOT #: 3019706, D.4. MEDICAL DEVICE EXPIRATION DATE: 31-JUL-2024, H.4. DEVICE MANUFACTURE DATE: 19-JAN-2023; D.4. MEDICAL DEVICE LOT #: UNKNOWN, D.4. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN, H.4. DEVICE MANUFACTURE DATE: UNKNOWN. H.3. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.
H.6 INVESTIGATION SUMMARY BD HAD NOT RECEIVED SAMPLES, BUT 1 PHOTO WAS PROVIDED FOR INVESTIGATION. THE PHOTO WAS REVIEWED AND THE INDICATED FAILURE MODE FOR GEL SMEARING WAS OBSERVED. ADDITIONALLY, 100 RETENTION SAMPLES FROM BD INVENTORY WERE VISUALLY INSPECTED AND GEL SMEARING WAS SEEN ON 8 TUBES. COMPLAINTS FOR SAMPLE QUALITY ARE UNDER STATISTICAL CONTROL FOR THE MONTH OF MARCH 2023. 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 GEL SMEARING. 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.
IT WAS REPORTED THAT AFTER CENTRIFUGATION WITH BD VACUTAINER® LH PST¿ II PLUS BLOOD COLLECTION TUBES GEL SMEARING IS OCCURRING. THIS OCCURRED WITH MULTIPLE LOTS AND PATIENT IMPACT WAS NOT REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM FRENCH TO ENGLISH: FOR THE LAST MONTH AND A HALF, WE HAVE HAD PROBLEMS WITH HEPARIN GEL TUBES 233678 WHICH CONTAIN GEL PARTICLES ON THE WALL (+ SUSPENSION) AFTER CENTRIFUGATION. THIS GENERATES ALARMS ON OUR ISE MODULE OF OUR COBAS 8000 CHAIN. THE MOST IMPACTED LOT NUMBERS ARE 3019706 AND 2308629, BUT THIS IS MORE LOTS.
IT WAS REPORTED THAT AFTER CENTRIFUGATION WITH BD VACUTAINER® LH PST¿ II PLUS BLOOD COLLECTION TUBES GEL SMEARING IS OCCURRING. THIS OCCURRED WITH MULTIPLE LOTS AND PATIENT IMPACT WAS NOT REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM FRENCH TO ENGLISH: FOR THE LAST MONTH AND A HALF, WE HAVE HAD PROBLEMS WITH HEPARIN GEL TUBES 233678 WHICH CONTAIN GEL PARTICLES ON THE WALL (+ SUSPENSION) AFTER CENTRIFUGATION. THIS GENERATES ALARMS ON OUR ISE MODULE OF OUR COBAS 8000 CHAIN. THE MOST IMPACTED LOT NUMBERS ARE 3019706 AND 2308629, BUT THIS IS MORE LOTS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2258546 | BD VACUTAINER® LH PST¿ II PLUS BLOOD COLLECTION TUBES | BLOOD SPECIMEN COLLECTION DEVICE | JKA | BECTON, DICKINSON AND COMPANY (BD) | SEE H.10 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |