BD VACUTAINER® SERUM BLOOD COLLECTION TUBES
Report
- Report Number
- 1024879-2022-00150
- Event Type
- Malfunction
- Date Received
- March 17, 2022
- Date of Event
- March 4, 2022
- Report Date
- July 20, 2022
- Manufacturer
- BECTON, DICKINSON & CO., (BD)
- Product Code
- JKA
- UDI-DI
- 00382903678204
- PMA / PMN Number
- BK050036
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AL, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
ADDITIONAL INFORMATION WAS RECEIVED TO CAPTURE THE ADDITIONAL LOTS PROVIDED. PLEASE SEE THE PROVIDED INFORMATION BELOW. THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: D.4. MEDICAL DEVICE LOT #: 1123114. D.4. MEDICAL DEVICE EXPIRATION DATE: 2023-04-30 . H.4. DEVICE MANUFACTURE DATE: 2021-05-03 . D.4. MEDICAL DEVICE LOT #: 1349713. D.4. MEDICAL DEVICE EXPIRATION DATE: 2023-12-31. H.4. DEVICE MANUFACTURE DATE: 2021-12-15. D.4. MEDICAL DEVICE LOT #: 1193348. D.4. MEDICAL DEVICE EXPIRATION DATE: 2023-07-31. H.4. DEVICE MANUFACTURE DATE: 2021-07-12.
DATE OF EVENT: 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 LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 1193347. MEDICAL DEVICE EXPIRATION DATE: 2023-07-31 . DEVICE MANUFACTURE DATE: 2021-07-12. MEDICAL DEVICE LOT #: 1319592 . MEDICAL DEVICE EXPIRATION DATE: 2023-11-30 . DEVICE MANUFACTURE DATE: 2021-11-15. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.
THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D9: DEVICE AVAILABLE FOR EVAL YES, D9: RETURNED TO MANUFACTURER ON: 18-MAR-2022. H6: INVESTIGATION SUMMARY: BD RECEIVED 18 SAMPLES FROM THE CUSTOMER IN SUPPORT OF THIS COMPLAINT. A VISUAL EVALUATION OF THE SAMPLES WAS PERFORMED, AND CONFIRM THE FAILURE MODE OF ADDITIVE ABNORMALITY AS THEY APPEAR TO HAVE UNEVEN ADDITIVE SPRAY PATTERN, RESULTING IN AN ABNORMAL APPEARANCE OF THE ADDITIVE COLLECTING ON THE INSIDE WALLS OF THE TUBES. IT IS IMPORTANT TO NOTE THAT THE ADDITIVE AMOUNT DISPENSED INTO THE TUBE IS ACCURATE, ONLY THE SPRAY PATTERN IS ABNORMAL. THE ROOT CAUSE OF THE ADDITIVE ABNORMALITY WAS CLOGGED NOZZLES AND AN INCONSISTENT FLOW OF TRAYS CAUSING THE TRAYS TO BE SLIGHTLY OUT OF ALIGNMENT CAUSING THE COATING NOZZLES TO SPRAY ALONG THE EDGE OF THE TUBE. CORRECTIVE MEASURES HAVE BEEN IMPLEMENTED TO MITIGATE THIS ISSUE AND REDUCE POTENTIAL FUTURE OCCURRENCES. THE DEVICE HISTORY RECORDS WERE REVIEWED WITH NO ISSUES BEING IDENTIFIED. THERE WAS 1 RELATED QUALITY NOTIFICATION FOR BATCH 1123114. THE ROOT CAUSE WAS ATTRIBUTED TO A NOZZLE SETTING THAT CAUSED THE COATING TO SPRAY ALONG THE TOP RIM OF THE TUBES AS WELL AS OUTSIDE OF THE TUBE. CORRECTIVE ACTION WAS INITIATED, AND THE PRODUCT WAS 100% REWORKED, SAMPLED, AND RELEASED. ALL PROCESS AND FINAL INSPECTIONS COMPLY WITH SPECIFICATION REQUIREMENTS. ALL PROCESS AND FINAL INSPECTIONS COMPLY WITH SPECIFICATION REQUIREMENTS.
IT WAS REPORTED WHEN USING THE BD VACUTAINER® SERUM BLOOD COLLECTION TUBES, THE DEVICE EXPERIENCED FOREIGN MATTER WITHIN THE TUBE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: IT WAS REPORTED THAT THERE IS CONDENSATION IN THE TUBES. ONE OF MY ACCOUNTS ORDERED SOME OF THE BLOOD COLLECTION TUBES AND SAID THERE WAS CONDENSATION IN THE TUBES. THEY HAVE 5 VIALS OF LOT# 1193347 AND 4 VIALS OF LOT# 1319592. ADDITIONAL LOT INFORMATION HAS BEEN PROVIDED. 03/22/2022. ANOTHER LOT HAS BEEN ADDED TO THE GRID, LOT #1123114,1349713, 1193348.
IT WAS REPORTED WHEN USING THE BD VACUTAINER® SERUM BLOOD COLLECTION TUBES, THE DEVICE EXPERIENCED FOREIGN MATTER WITHIN THE TUBE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: IT WAS REPORTED THAT THERE IS CONDENSATION IN THE TUBES. ONE OF MY ACCOUNTS ORDERED SOME OF THE BLOOD COLLECTION TUBES AND SAID THERE WAS CONDENSATION IN THE TUBES. THEY HAVE 5 VIALS OF LOT# 1193347 AND 4 VIALS OF LOT# 1319592.
IT WAS REPORTED WHEN USING THE BD VACUTAINER® SERUM BLOOD COLLECTION TUBES, THE DEVICE EXPERIENCED FOREIGN MATTER WITHIN THE TUBE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: IT WAS REPORTED THAT THERE IS CONDENSATION IN THE TUBES. ONE OF MY ACCOUNTS ORDERED SOME OF THE BLOOD COLLECTION TUBES AND SAID THERE WAS CONDENSATION IN THE TUBES. THEY HAVE 5 VIALS OF LOT# 1193347 AND 4 VIALS OF LOT# 1319592. ADDITIONAL LOT INFORMATION HAS BEEN PROVIDED. 03/22/2022. ANOTHER LOT HAS BEEN ADDED TO THE GRID, LOT #1123114,1349713, 1193348.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 938272 | BD VACUTAINER® SERUM BLOOD COLLECTION TUBES | BLOOD SPECIMEN COLLECTION DEVICE | JKA | BECTON, DICKINSON & CO., (BD) | SEE H.10. | 00382903678204 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |