BD VACUTAINER® BUFFERED SODIUM CITRATE (9NC) BLOOD COLLECTION TUBES
Report
- Report Number
- 1917413-2023-00151
- Event Type
- Malfunction
- Date Received
- February 26, 2023
- Date of Event
- February 13, 2023
- Report Date
- March 13, 2023
- Manufacturer
- BECTON, DICKINSON & CO. (BROKEN BOW)
- Product Code
- JKA
- UDI-DI
- 50382903630832
- PMA / PMN Number
- K013971
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 2166978. MEDICAL DEVICE EXPIRATION DATE: 2023-03-31. DEVICE MANUFACTURE DATE: 2022-06-15. MEDICAL DEVICE LOT #: 2200057. MEDICAL DEVICE EXPIRATION DATE: 2023-04-30. DEVICE MANUFACTURE DATE: 2022-07-19. MEDICAL DEVICE LOT #: 2200054. MEDICAL DEVICE EXPIRATION DATE: 2023-04-30. DEVICE MANUFACTURE DATE: 2022-07-19. MEDICAL DEVICE LOT #: 2132051. MEDICAL DEVICE EXPIRATION DATE: 2023-02-28. DEVICE MANUFACTURE DATE: 2022-05-12. 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 WITH ADDITIONAL INFORMATION: D.10 DEVICE AVAILABLE FOR EVAL? YES; D.10 RETURNED TO MANUFACTURER ON: 3-MAR-2023. H.6. INVESTIGATION SUMMARY: BD RECEIVED 8 CUSTOMER SAMPLES FROM LOT 2200057 (NO SAMPLES WERE RECEIVED FROM 2166978, 2200054, AND 2132051) AND 3 PHOTOS WERE RETURNED BY THE CUSTOMER IN SUPPORT OF THIS COMPLAINT. THE PHOTOS WERE EVALUATED AND DO NOT SHOW OVERFILL. THE BLOOD MENISCUS IS VISIBLE UNDER THE BOTTOM EDGE OF THE CLOSURE. 8 SAMPLE TUBES WERE INSPECTED WITH 0 VISIBLE DEFECTS. FUNCTIONAL TESTING WAS PERFORMED AT THE MANUFACTURING SITE ON THE SAMPLE TUBES AND THE ISSUE OF OVERFILL WAS NOT OBSERVED AS ALL TUBES WERE WITHIN SPECIFICATION LIMITS. THE QUANTITY OF BLOOD DRAWN INTO EVALUATED TUBES VARIES WITH ALTITUDE, AMBIENT TEMPERATURE, BAROMETRIC PRESSURE, TUBE AGE, VENOUS PRESSURE, AND FILLING TECHNIQUE. ADDITIONALLY, 10 RETENTION SAMPLES FROM EACH LOT WERE FUNCTIONALLY TESTED AND THE ISSUE OF OVERFILL WAS NOT OBSERVED AS ALL TUBES WERE WITHIN SPECIFICATION LIMITS. BD WAS UNABLE TO CONFIRM THE CUSTOMER¿S INDICATED FAILURE MODE WITH THE SAMPLES AND PHOTOS PROVIDED. THE DEFECT WAS NOT OBSERVED IN THE SAMPLE AND RETENTION TESTING. THE DEVICE HISTORY RECORDS FOR ALL LOTS 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. H3 OTHER TEXT : SEE H.10.
IT WAS REPORTED WHEN USING THE BD VACUTAINER® BUFFERED SODIUM CITRATE (9NC) BLOOD COLLECTION TUBE THERE WAS OVERFILL. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "THE TUBES ARE OVERFILLING FOR CAT 363083 LOTS 2166978, 2200057, 2200054, AND 2132051.".
IT WAS REPORTED WHEN USING THE BD VACUTAINER® BUFFERED SODIUM CITRATE (9NC) BLOOD COLLECTION TUBE THERE WAS OVERFILL. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "THE TUBES ARE OVERFILLING FOR CAT 363083 LOTS 2166978, 2200057, 2200054, AND 2132051.".
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 388175 | BD VACUTAINER® BUFFERED SODIUM CITRATE (9NC) BLOOD COLLECTION TUBES | BLOOD SPECIMEN COLLECTION DEVICE | JKA | BECTON, DICKINSON & CO. (BROKEN BOW) | 363083 | SEE H.10 | 50382903630832 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |