BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER C&S TRANSFER STRAW KIT

    MDR report key: 6823261 · Received August 28, 2017

    Report

    Report Number
    6823261
    Event Type
    Malfunction
    Date Received
    August 28, 2017
    Date of Event
    August 5, 2017
    Report Date
    August 10, 2017
    Manufacturer
    BECTON, DICKINSON AND COMPANY
    Product Code
    OIE
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    STAFF HAVE REPORTED DIFFICULTY TRANSFERRING URINE FROM SPECIMEN CUPS (IN PATIENTS WITH NO FOLEY) TO THE BD VACUTAINER TUBE USING THE C&S TRANSFER STRAW KIT. THIS HAS RESULTED TO EXPOSURES AND NEAR MISSES WITH URINE BEING SPILLED, WHICH IS PARTICULARLY CONCERNING WHEN DEALING WITH PATIENTS RECEIVING CHEMOTHERAPY. THE STRAW END OF THE KIT HAS TO BE HELD IN THE SPECIMEN CUP WHILE THE VACUTAINER TUBE IS PUSHED DOWN ONTO THE NEEDLE ON THE OTHER END OF THE STRAW KIT. STAFFS HAVE REPORTED DIFFICULTY IN GETTING THE NEEDLE TO PENETRATE THE YELLOW RUBBER CAP ON THE END OF THE VACUTAINER, RESULTING IN JARRING OF THE SPECIMEN CUP AND SPILLAGE OF URINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    605030 BD VACUTAINER C&S TRANSFER STRAW KIT URINE COLLECTION DEVICE OIE BECTON, DICKINSON AND COMPANY 7097784

    Patients

    Seq Age Sex Outcome Treatment
    1