BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER BUFFERED SODIUM CITRATE (9NC) BLOOD COLLECTION TUBES

    MDR report key: 11871821 · Received May 24, 2021

    Report

    Report Number
    1917413-2021-00433
    Event Type
    Malfunction
    Date Received
    May 24, 2021
    Date of Event
    April 27, 2021
    Report Date
    July 2, 2021
    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
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY: NO CUSTOMER SAMPLES AND NO PHOTO WERE RETURNED BY THE CUSTOMER IN SUPPORT OF THIS COMPLAINT. THEREFORE, 10 PRODUCTION LOT IN-HOUSE RETENTION SAMPLES FROM THE BD INVENTORY WERE FUNCTIONALLY TESTED AND NO ISSUES WERE OBSERVED RELATING TO DRAW VOLUME OR INSTRUMENT INCAPABILITY AS ALL SAMPLES MET SPECIFICATIONS. BD WAS UNABLE TO CONFIRM AND/OR DUPLICATE THE CUSTOMER¿S INDICATED FAILURE MODE BECAUSE NO SAMPLES WERE RETURNED TO BE TESTED AND THE DEFECT WAS NOT OBSERVED IN THE RETENTION TESTING. 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. H3 OTHER TEXT : SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD VACUTAINER® BUFFERED SODIUM CITRATE (9NC) BLOOD COLLECTION TUBES, THE DEVICE EXPERIENCED UNDERFILL OR LOW DRAW OF A TUBE WITH BLOOD, OVERFILL. THIS EVENT (UNDERFILL) OCCURRED ONCE WITH LOT 0316275. THIS EVENT (OVERFILL) OCCURRED TWO TIMES WITH LOT 1014037. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: IT WAS REPORTED THAT TUBES ARE UNDER FILLING AND OVERFILLING. THEY ALSO NON COMPATIBLE WITH THE LAB INSTRUMENT. VERBIAGE RECEIVED, - "PER EMAIL: I SPOKE WITH STOREROOM AND THEY HAVE BEEN DISCARDING THOSE WITH THE LOT # 0316275 EXP 5/31/21. THERE HAVE BEEN ISSUES WITH THIS TUBE PREVIOUSLY REGARDING NON-COMPATIBILITY WITH OUR LAB INSTRUMENTS. THE ONE I USED TODAY WAS CLEARLY UNDER FILLED. WE ARE PULLING ALL OF THOSE TUBES FROM THE ED. THE STOREROOM MANGER AND I FOLLOWING UP WITH HIS TEAM TO DETERMINE NEXT STEPS. THE OTHER TUBES THAT EXPIRE IN OCTOBER WERE TESTED BY ME. I DREW 3 SEPARATE ONES AND TWO OF THEM OVERFILLED AUTOMATICALLY AND ONE OF THEM WAS ON THE MARK."

    Additional Manufacturer Narrative · 1

    MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 0316275- THE CUSTOMER INCLUDED LOT 0316275, BUT IT DOES NOT MATCH THE MATERIAL NUMBER IN OUR SYSTEM. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN. MEDICAL DEVICE LOT #: 1014037. MEDICAL DEVICE EXPIRATION DATE: 2021-10-31. DEVICE MANUFACTURE DATE: 2021-01-14. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED WHEN USING THE BD VACUTAINER® BUFFERED SODIUM CITRATE (9NC) BLOOD COLLECTION TUBES, THE DEVICE EXPERIENCED UNDERFILL OR LOW DRAW OF A TUBE WITH BLOOD, OVERFILL. THIS EVENT (UNDERFILL) OCCURRED ONCE WITH LOT 0316275. THIS EVENT (OVERFILL) OCCURRED TWO TIMES WITH LOT 1014037. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: IT WAS REPORTED THAT TUBES ARE UNDER FILLING AND OVERFILLING. THEY ALSO NON COMPATIBLE WITH THE LAB INSTRUMENT. VERBIAGE RECEIVED, - "PER EMAIL: I SPOKE WITH STOREROOM AND THEY HAVE BEEN DISCARDING THOSE WITH THE LOT # 0316275 EXP 5/31/21. THERE HAVE BEEN ISSUES WITH THIS TUBE PREVIOUSLY REGARDING NON-COMPATIBILITY WITH OUR LAB INSTRUMENTS. THE ONE I USED TODAY WAS CLEARLY UNDER FILLED. WE ARE PULLING ALL OF THOSE TUBES FROM THE ED. THE STOREROOM MANGER AND I FOLLOWING UP WITH HIS TEAM TO DETERMINE NEXT STEPS. THE OTHER TUBES THAT EXPIRE IN OCTOBER WERE TESTED BY ME. I DREW 3 SEPARATE ONES AND TWO OF THEM OVERFILLED AUTOMATICALLY AND ONE OF THEM WAS ON THE MARK."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    765814 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