BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® PLUS PLASTIC TRANSPORT KIT FOR UA CHEMISTRY URINE TESTING

    MDR report key: 7059030 · Received November 27, 2017

    Report

    Report Number
    1917413-2017-00216
    Event Type
    Malfunction
    Date Received
    November 27, 2017
    Date of Event
    April 4, 2016
    Report Date
    January 24, 2018
    Manufacturer
    BECTON, DICKINSON & CO.
    Product Code
    KDT
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: A SAMPLE WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO IRREGULARITIES DURING THE MANUFACTURE OF THE REPORTED LOT # 5295510. CONCLUSION: WITHOUT A SAMPLE, AN ABSOLUTE ROOT CAUSE FOR THIS INCIDENT CANNOT BE DETERMINED AS BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE MODE.

    Additional Manufacturer Narrative · 1

    THE INITIAL MDR WAS SUBMITTED WITH THE 510K NUMBER LISTED AS K790366. IT IS CORRECTED TO READ EXEMPT.

    Description of Event or Problem · 1

    IT WAS REPORTED WITH THE 10.0 ML 16X100 MM BD VACUTAINER® PLUS PLASTIC TRANSPORT KIT FOR UA CHEMISTRY URINE TESTING THAT SEVERAL ISSUES WITH THE STOPPER OCCURRED. THIS INCLUDES: THE STOPPER BEING HALF WAY OFF BEFORE USE, STOPPER COULDN'T GO ON COMPLETELY, TRANSFERRING URINE WOULD NOT FILL THE NEW TUBE COMPLETELY. SPILLS ALSO RESULTED FROM NEEDLES BEING STUCK IN THE TRANSFER DEVICE. NO INJURY OR MEDICAL INTERVENTION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    841507 BD VACUTAINER® PLUS PLASTIC TRANSPORT KIT FOR UA CHEMISTRY URINE TESTING URINE COLLECTION SET KDT BECTON, DICKINSON & CO. 5295510

    Patients

    Seq Age Sex Outcome Treatment
    1 Other