BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINILOC

    MDR report key: 1233019 · Received November 12, 2008

    Report

    Report Number
    1233019
    Event Type
    Malfunction
    Date Received
    November 12, 2008
    Date of Event
    September 29, 2008
    Report Date
    November 12, 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

    AUNT WAS HOLDING PATIENT WHEN MOVING HIM, SHE FOUND TUBING DETACHED FROM HUBER NEEDLE (BARD MINILOC). AUNT CLAMPED OFF TUBING AND NOTIFIED RN WHO CAME IN AND REMOVED NEEDLE. REACCESSED MEDIPORT WITHOUT INCIDENT WITH A 20G 3/4" GRIPPER PLUS NEEDLE. TUBING DISCONNECTED (CAME UNGLUED) FROM LUER LOCK PORTION OF NEEDLE. THIS IS AN ONGOING ISSUE WITH BARD MINILOC HUBER NEEDLES. ALL HOSPITAL LOTS WERE SWAPPED OUT IN JUNE AND JULY AND THERE HAD BEEN NO MORE ISSUES UNTIL THIS ONE. WILL REPORT TO BARD AND DETERMINE ACTION STEPS WHICH MAY INCLUDE SWITCHING TO A NEW PRODUCT HOSPITAL WIDE. IT IS POSSIBLE THAT THIS PARTICULAR NEEDLE IS ONE OF THE OLD LOTS, BUT SINCE THE PACKAGING WAS THROWN AWAY WE CANNOT BE SURE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 1 YR