BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFTLOC SAFETY INFUSION SET

    MDR report key: 3904282 · Received June 23, 2014

    Report

    Report Number
    3904282
    Event Type
    Malfunction
    Date Received
    June 23, 2014
    Date of Event
    June 11, 2014
    Report Date
    June 23, 2014
    Manufacturer
    BARD ACCESS SYSTEMS, INC.
    Product Code
    FMI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    YELLOW FLUID WAS NOTED AROUND THE BIOPATCH ON THE PATIENT'S CHEST PORT. PATIENT WAS RECEIVING METHOTREXATE. BLOOD RETURN WAS OKAY. THE LINE WAS DEACCESSED (HUBER NEEDLE REMOVED). PATIENT'S SKIN CLEANSED. LINE REACCESSED WITH NEW HUBER NEEDLE. LEAK IN NEEDLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    367052 LIFTLOC SAFETY INFUSION SET NEEDLE, HYPODERMIC, SINGLE FMI BARD ACCESS SYSTEMS, INC. 0642234 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 2 YR CHEMOTHERAPY