BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER URINE ANALYSIS PRESERVATIVE TUBE

    MDR report key: 12751706 · Received November 4, 2021

    Report

    Report Number
    1917413-2021-00943
    Event Type
    Malfunction
    Date Received
    November 4, 2021
    Date of Event
    October 7, 2021
    Report Date
    October 12, 2021
    Manufacturer
    BECTON, DICKINSON & CO. (BROKEN BOW)
    Product Code
    JTW
    UDI-DI
    50382903649926
    PMA / PMN Number
    K790366
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: BD HAD NOT RECEIVED SAMPLES FOR INVESTIGATION. THE INDICATED FAILURE MODE FOR UNDERFILL WAS OBSERVED, AS THE TUBES HAVE SPECIMEN LEVELS THAT ARE BELOW THE FILL LINE. THE QUANTITY OF SPECIMEN DRAWN INTO EVALUATED TUBES VARIES WITH ALTITUDE, AMBIENT TEMPERATURE, BAROMETRIC PRESSURE, TUBE AGE, VENOUS PRESSURE, AND FILLING TECHNIQUE. ADDITIONALLY, TEN RETENTION SAMPLES FROM BD INVENTORY WERE EVALUATED BY FUNCTIONAL DRAW TESTING AND THE ISSUE OF UNDERFILL WAS NOT OBSERVED. BASED ON A REVIEW OF THE DEVICE HISTORY RECORD FOR THE INCIDENT LOT, ALL PRODUCT SPECIFICATIONS AND REQUIREMENTS FOR LOT RELEASE WERE MET. THERE WERE NO RELATED QUALITY NOTIFICATIONS. THIS COMPLAINT HAS BEEN CONFIRMED FOR THE INDICATED FAILURE MODE OF UNDERFILL.

    Description of Event or Problem · 1

    IT WAS REPORTED WHEN USING THE BD VACUTAINER® URINE ANALYSIS PRESERVATIVE TUBE THERE WAS UNDER-FILL OR LOW DRAW OF A TUBE WITH BLOOD. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "THE TUBES ARE UNDERFILLING. THE TUBES ARE NOT ALIQUOTING ALL THE WAY TO THE MINIMUM LINES."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1653002 BD VACUTAINER URINE ANALYSIS PRESERVATIVE TUBE SPECIMEN TRANSPORT AND STORAGE CONTAINER JTW BECTON, DICKINSON & CO. (BROKEN BOW) 364992 0227134 50382903649926

    Patients

    Seq Age Sex Outcome Treatment
    1