BD VACUTAINER® BLOOD COLLECTION TUBES BUFFERED SODIUM CITRATE 0.3ML - 0.109M
Report
- Report Number
- 9617032-2023-00142
- Event Type
- Malfunction
- Date Received
- February 8, 2023
- Date of Event
- January 26, 2023
- Report Date
- March 27, 2023
- Manufacturer
- BECTON, DICKINSON AND COMPANY (BD)
- Product Code
- JKA
- UDI-DI
- 50382903643054
- PMA / PMN Number
- K013971
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SW
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
THE FOLLOWING FIELDS WERE UPDATED WITH ADDITIONAL INFORMATION: H6. MAT: 364305. LOTS: 2189016, 2145266, 2277401, 2237440, 7184682 AND, 8163528. BD RECEIVED 7 PHOTOGRAPHS FROM THE CUSTOMER IN SUPPORT OF THIS COMPLAINT SHOWING UNDERFILL. ADDITIONALLY, 20 RETAINED SAMPLES OF EACH BATCH NUMBER (2189016, 2145266, 2277401 AND 2237440) OF THE BD INVENTORY, WERE FUNCTIONALLY TESTED AND IT WAS DETERMINED THAT ALL 80 TUBES DREW WITHIN SPECIFICATION. BD WAS ABLE TO CONFIRM THE CUSTOMER¿S INDICATED FAILURE MODE BASED ON THE PHOTOGRAPHS PROVIDED HOWEVER, THE ISSUE OF UNDERFILL WAS NOT OBSERVED IN THE RETENTION SAMPLE ANALYSIS RESULTS. BD WAS UNABLE TO DETERMINE A ROOT CAUSE FOR THE REPORTED ISSUE OF UNDERFILL. THE EXPIRATION DATES OF THE LOTS NUMBERS INVOLVED WERE: BATCH 7184682 EX. 31/03/2018, BATCH: 8163528 31/03/2019 AND BATCH: 2122532 EX. 31/01/2023 THEREFORE, TUBES FOR THESE LOTS WERE UNABLE TO BE TESTED. 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. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.
THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: UNKNOWN, MEDICAL DEVICE EXPIRATION DATE: UNKNOWN, AND DEVICE MANUFACTURE DATE: UNKNOWN. MEDICAL DEVICE LOT #: 7184682, MEDICAL DEVICE EXPIRATION DATE: 31-MAR-2018, AND DEVICE MANUFACTURE DATE: 03-JUL-2017. MEDICAL DEVICE LOT #: 8163528, MEDICAL DEVICE EXPIRATION DATE: 31-MAR-2019, AND DEVICE MANUFACTURE DATE: 12-JUN-2018. MEDICAL DEVICE LOT #: 2189016, MEDICAL DEVICE EXPIRATION DATE: 31-MAR-2023, AND DEVICE MANUFACTURE DATE: 08-JUL-2022. MEDICAL DEVICE LOT #: 2122532, MEDICAL DEVICE EXPIRATION DATE: 31-JAN-2023, AND DEVICE MANUFACTURE DATE: 02-MAY-2022. MEDICAL DEVICE LOT #: 2145266, MEDICAL DEVICE EXPIRATION DATE: 28-FEB-2023, AND DEVICE MANUFACTURE DATE: 25-MAY-2022. MEDICAL DEVICE LOT #: 2277401, MEDICAL DEVICE EXPIRATION DATE: 30-JUN-2023, AND DEVICE MANUFACTURE DATE: 04-OCT-2022. MEDICAL DEVICE LOT #: 2237440, MEDICAL DEVICE EXPIRATION DATE: 31-MAY-2023, AND DEVICE MANUFACTURE DATE: 25-AUG-2022. DEVICE EVALUATED BY MFR: 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 OF EACH BATCH NUMBER (2189016, 2145266, 2277401 AND 2237440) OF THE BD INVENTORY, WERE FUNCTIONALLY TESTED AND IT WAS DETERMINED THAT ALL 80 TUBES DREW WITHIN SPECIFICATION. BD WAS UNABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE MODE OF UNDERFILL BASED ON THE RETENTION SAMPLE TESTING. THE EXPIRATION DATES OF THE LOTS NUMBERS INVOLVED WERE: BATCH 7184682 EX. 31/03/2018, BATCH: 8163528 31/03/2019 AND BATCH: 2122532 EX. 31/01/2023 THEREFORE, TUBES FOR THESE LOTS WERE UNABLE TO BE TESTED. BD WAS UNABLE TO DETERMINE A ROOT CAUSE FOR THE REPORTED ISSUE OF UNDERFILL. 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. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.
IT WAS REPORTED THAT DURING USE WITH 7 KNOWN LOTS AND AN UNKNOWN LOT OF BD VACUTAINER® BLOOD COLLECTION TUBES BUFFERED SODIUM CITRATE 0.3ML - 0.109M THE TUBES WERE UNDERFILLING. THERE WAS NO PATIENT IMPACT REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM SWEDISH TO ENGLISH: DURING A TIME THE CUSTOMER HAS EXPERIENCED UNDERFILLING OF TUBES. INCIDENT OCCURRED: DURING USE. ADDITIONALLY, THE FSE PROVIDED THE FOLLOWING ADDITIONAL INFORMATION: THE CUSTOMER HAS DONE SOME INTERNAL INVESTIGATION OF THEIR OWN. THEY THINK THAT THE MARK ON THE TUBES ARE IN THE INCORRECT PLACE. THEY THINK THAT IS WHAT CAUSES TUBES TO BE CONSIDERED UNDERFILLED UNNECESSARY. I AM NOT SURE THAT THE INVESTIGATION IS CORRECTLY DONE, AS THEY HAVE TAKEN THAT THE LOWEST VOLUME THAT SHOULD BE ACCEPTED IS 2,4ML BLOOD. I HAVE NOT BEEN ABLE TO SEE IF THIS IS CORRECT OR NOT, SO CANNOT COMMENT ON THEIR INVESTIGATION.
IT WAS REPORTED THAT DURING USE WITH 7 KNOWN LOTS AND AN UNKNOWN LOT OF BD VACUTAINER® BLOOD COLLECTION TUBES BUFFERED SODIUM CITRATE 0.3ML - 0.109M THE TUBES WERE UNDERFILLING. THERE WAS NO PATIENT IMPACT REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM SWEDISH TO ENGLISH: DURING A TIME THE CUSTOMER HAS EXPERIENCED UNDERFILLING OF TUBES. INCIDENT OCCURRED: DURING USE. ADDITIONALLY, THE FSE PROVIDED THE FOLLOWING ADDITIONAL INFORMATION: THE CUSTOMER HAS DONE SOME INTERNAL INVESTIGATION OF THEIR OWN. THEY THINK THAT THE MARK ON THE TUBES ARE IN THE INCORRECT PLACE. THEY THINK THAT IS WHAT CAUSES TUBES TO BE CONSIDERED UNDERFILLED UNNECESSARY. I AM NOT SURE THAT THE INVESTIGATION IS CORRECTLY DONE, AS THEY HAVE TAKEN THAT THE LOWEST VOLUME THAT SHOULD BE ACCEPTED IS 2,4ML BLOOD. I HAVE NOT BEEN ABLE TO SEE IF THIS IS CORRECT OR NOT, SO CANNOT COMMENT ON THEIR INVESTIGATION.
IT WAS REPORTED THAT DURING USE WITH 7 KNOWN LOTS AND AN UNKNOWN LOT OF BD VACUTAINER® BLOOD COLLECTION TUBES BUFFERED SODIUM CITRATE 0.3ML - 0.109M THE TUBES WERE UNDERFILLING. THERE WAS NO PATIENT IMPACT REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM SWEDISH TO ENGLISH: DURING A TIME THE CUSTOMER HAS EXPERIENCED UNDERFILLING OF TUBES. INCIDENT OCCURRED: DURING USE. ADDITIONALLY, THE FSE PROVIDED THE FOLLOWING ADDITIONAL INFORMATION: THE CUSTOMER HAS DONE SOME INTERNAL INVESTIGATION OF THEIR OWN. THEY THINK THAT THE MARK ON THE TUBES ARE IN THE INCORRECT PLACE. THEY THINK THAT IS WHAT CAUSES TUBES TO BE CONSIDERED UNDERFILLED UNNECESSARY. I AM NOT SURE THAT THE INVESTIGATION IS CORRECTLY DONE, AS THEY HAVE TAKEN THAT THE LOWEST VOLUME THAT SHOULD BE ACCEPTED IS 2,4ML BLOOD. I HAVE NOT BEEN ABLE TO SEE IF THIS IS CORRECT OR NOT, SO CANNOT COMMENT ON THEIR INVESTIGATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2316515 | BD VACUTAINER® BLOOD COLLECTION TUBES BUFFERED SODIUM CITRATE 0.3ML - 0.109M | BLOOD SPECIMEN COLLECTION DEVICE | JKA | BECTON, DICKINSON AND COMPANY (BD) | 364305 | SEE H.10 | 50382903643054 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |