BD VACUTAINER® BUFFERED TRISODIUM CITRATE PLUS BLOOD COLLECTION TUBES
Report
- Report Number
- 9617032-2022-01011
- Event Type
- Malfunction
- Date Received
- October 12, 2022
- Date of Event
- October 4, 2022
- Report Date
- November 22, 2022
- Manufacturer
- BECTON, DICKINSON AND COMPANY (BD)
- Product Code
- JKA
- UDI-DI
- 50382903630481
- PMA / PMN Number
- K013971
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
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 #: 2152421, MEDICAL DEVICE EXPIRATION DATE: 2023-02-28, DEVICE MANUFACTURE DATE: 2022-06-01. MEDICAL DEVICE LOT #: 2152402, MEDICAL DEVICE EXPIRATION DATE: 2023-02-28, DEVICE MANUFACTURE DATE: 2022-06-01. 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 DID NOT RECEIVE SAMPLES OR PHOTOGRAPHS FROM THE CUSTOMER IN SUPPORT OF THIS COMPLAINT. THEREFORE, 20 RETAINED SAMPLES FROM EACH BATCH NUMBERS: 2152402, AND 2152421 OF THE BD INVENTORY WERE FUNCTIONALLY TESTED AND THE ISSUE OF OVERFILL WAS NOT OBSERVED AS ALL 40 TUBES DREW WITHIN SPECIFICATION. BD WAS UNABLE TO CONFIRM CUSTOMERS¿ INDICATED FAILURE MODE BASED ON THE RETAINED SAMPLES¿ TEST RESULTS FOR BOTH BATCHES: 2152402, AND 2152421. BD WAS UNABLE TO DETERMINE A ROOT CAUSE FOR THE REPORTED DEFECT. A COMPLAINT HISTORY REVIEW WAS CONDUCTED AND ONLY THE CURRENT COMPLAINT WAS FOUND RELATING TO THE INCIDENT LOT NUMBERS: 2152402, 2152421 THE ¿AS REPORTED¿ DEFECT CODE. 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. H3 OTHER TEXT : SEE H.10.
THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D9: DEVICE AVAILABLE FOR EVAL: YES. D9: RETURNED TO MANUFACTURER ON 2022-11-23. H.6. INVESTIGATION SUMMARY: BD DID RECEIVE 20 SAMPLES (10 FROM EACH BATCH NUMBERS: 2152421, AND 10 FROM 2152402) FROM THE CUSTOMER IN SUPPORT OF THIS COMPLAINT. THE CUSTOMER SAMPLES ALONG WITH 20 RETENTION SAMPLES FROM EACH BATCH NUMBERS OF THE BD INVENTORY WERE FUNCTIONALLY TESTED AND THE ISSUE OF OVERFILL WAS NOT OBSERVED AS ALL 40 TUBES DREW WITHIN SPECIFICATION. BD WAS UNABLE TO CONFIRM CUSTOMERS¿ INDICATED FAILURE MODE BASED ON THE SAMPLES PROVIDED AND THE RETAINED SAMPLES¿ TEST RESULTS FOR BOTH BATCHES: 2152402, AND 2152421. BD WAS UNABLE TO DETERMINE A ROOT CAUSE FOR THE REPORTED DEFECT. 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.
IT WAS REPORTED WHEN USING THE BD VACUTAINER® BUFFERED TRISODIUM CITRATE PLUS BLOOD COLLECTION TUBE THERE WAS OVERFILL. THIS EVENT AFFECTED 2 TUBES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER AND TRANSLATED TO ENGLISH. THE CUSTOMER STATED: WE WOULD LIKE TO MAKE A CLAIM ON 2 LOTS OF TUBES FOR A VACUUM DEFECT. N° 2152421 EXP FEBRUARY 2023 AND N°2152402 EXP FEBRUARY 2023. THEY PUT IN ALARM THE AUTOMATON FOR A VOLUME OF FILLING TOO HIGH."
IT WAS REPORTED WHEN USING THE BD VACUTAINER® BUFFERED TRISODIUM CITRATE PLUS BLOOD COLLECTION TUBE THERE WAS OVERFILL. THIS EVENT AFFECTED 2 TUBES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER AND TRANSLATED TO ENGLISH. THE CUSTOMER STATED: WE WOULD LIKE TO MAKE A CLAIM ON 2 LOTS OF TUBES FOR A VACUUM DEFECT. N° 2152421 EXP FEBRUARY 2023 AND N°2152402 EXP FEBRUARY 2023. THEY PUT IN ALARM THE AUTOMATON FOR A VOLUME OF FILLING TOO HIGH."
IT WAS REPORTED WHEN USING THE BD VACUTAINER® BUFFERED TRISODIUM CITRATE PLUS BLOOD COLLECTION TUBE THERE WAS OVERFILL. THIS EVENT AFFECTED 2 TUBES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER AND TRANSLATED TO ENGLISH. THE CUSTOMER STATED: WE WOULD LIKE TO MAKE A CLAIM ON 2 LOTS OF TUBES FOR A VACUUM DEFECT. N° 2152421 EXP FEBRUARY 2023 AND N°2152402 EXP FEBRUARY 2023. THEY PUT IN ALARM THE AUTOMATON FOR A VOLUME OF FILLING TOO HIGH."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2658153 | BD VACUTAINER® BUFFERED TRISODIUM CITRATE PLUS BLOOD COLLECTION TUBES | BLOOD SPECIMEN COLLECTION DEVICE | JKA | BECTON, DICKINSON AND COMPANY (BD) | 363048 | SEE H.10 | 50382903630481 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |