BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINILOC

    MDR report key: 1081160 · Received July 9, 2008

    Report

    Report Number
    1081160
    Event Type
    Malfunction
    Date Received
    July 9, 2008
    Date of Event
    March 29, 2008
    Report Date
    July 9, 2008
    Manufacturer
    BARD ACCESS SYSTEMS
    Product Code
    FMI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US

    Narratives

    Description of Event or Problem · 1

    PATIENT ARRIVED ON UNIT FROM PEDS HEM/ONC CLINIC WITH MEDIPORT ACCESSED WITH MINILOC 22G 3/4 INCH NEEDLE. PT. CALLED TO RN THAT TUBING WAS LEAKING. RN RESPONDED AND FOUND FEMALE END OF TUBING HAD SEPARATED FROM DEVICE AND BLOOD WAS DRIPPING FROM END. NEEDLE REMOVED AND MEDIPORT REACCESSED WITH ANOTHER MANUFACTURER'S NEEDLE. MINILOC NEEDLE EXAMINED BY CLINICAL ENGINEERING. APPEARS TUBING CAME UNGLUED FROM LUER LOCK END. THERE ARE ON-GOING ISSUES WITH MINILOC NEEDLES. BARD HAS VERBALLY SAID THEY CHANGED THE MANUFACTURING GLUING PROCESS IN APRIL 2008, AND SENT US ALL NEW NEEDLES TO REPLACE OLD STOCK. REPLACEMENT BEGAN IN INVENTORY CONTROL ON 5-8-08.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MINILOC INFUSION SET, HUBER NEEDLE FMI BARD ACCESS SYSTEMS 0632234 *

    Patients

    Seq Age Sex Outcome Treatment
    1 4 YR