BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® SODIUM HEPARINN (NH) BLOOD COLLECTION TUBES

    MDR report key: 22060316 · Received May 21, 2025

    Report

    Report Number
    1917413-2025-00646
    Event Type
    Malfunction
    Date Received
    May 21, 2025
    Date of Event
    April 22, 2025
    Report Date
    July 3, 2025
    Manufacturer
    BECTON, DICKINSON & CO. (BROKEN BOW)
    Product Code
    JKA
    UDI-DI
    30382903678717
    PMA / PMN Number
    K944566
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    E1: INITIAL REPORTER FACILITY NAME: QINLI BIOTECHNOLOGY CO., LTD(GENERAL LIFE BIOTECHNOLOGY CO., LTD. (GLB)) A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY BD RECEIVED ONE PHOTO FOR INVESTIGATION. THE PHOTO DISPLAYS THREE UNUSED TUBES POSITIONED ON THEIR TOPS BUT DOES NOT SHOW THE CUSTOMER'S INDICATED FAILURE MODE. A TOTAL OF 100 RETAINED SAMPLES WERE VISUALLY INSPECTED, AND ALL WERE FOUND WITH THE HEMOGARD CLOSURE ASSEMBLY CORRECTLY ASSEMBLED AND PLACED ON THE TUBES. FUNCTIONAL TESTS WERE CONDUCTED ON 10 RETAINED SAMPLES, AND ALL TUBES MET THE SPECIFICATION LIMITS. BASED ON A REVIEW OF THE DEVICE HISTORY RECORD FOR THE INCIDENT LOT, ALL PRODUCT SPECIFICATIONS AND REQUIREMENTS FOR LOT RELEASE WERE MET. THIS COMPLAINT HAS NOT BEEN CONFIRMED FOR THE INDICATED FAILURE MODE: UNDERFILL. NO DEFINITIVE ROOT CAUSE COULD BE ESTABLISHED FOR THE REPORTED DEFECT. 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 THE IDENTIFICATION OF EMERGING TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD VACUTAINER® SODIUM HEPARINN (NH) BLOOD COLLECTION TUBES, 100 TUBES UNDERFILLED. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD VACUTAINER® SODIUM HEPARINN (NH) BLOOD COLLECTION TUBES, 100 TUBES UNDERFILLED. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    937118 BD VACUTAINER® SODIUM HEPARINN (NH) BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO. (BROKEN BOW) 4137232 30382903678717

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown