BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINILOC SAFETY INFUSION SET

    MDR report key: 5107233 · Received September 28, 2015

    Report

    Report Number
    5107233
    Event Type
    Malfunction
    Date Received
    September 28, 2015
    Date of Event
    March 11, 2015
    Report Date
    September 24, 2015
    Manufacturer
    BARD ACCESS SYSTEMS, INC.
    Product Code
    FPA
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    MINILOC HUBER NEEDLE USED TO ACCESS PATIENT'S PAC (PULMONARY ARTERY CATHETER) LINE WOULD LEAK AT THE RIGHT ANGLE OF HUBER NEEDLE WHEN NORMAL PRESSURE WAS EXERTED TO FLUSH THE LINE WITH 0.9NS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    639747 MINILOC SAFETY INFUSION SET SET, IV, ADMINISTRATION FPA BARD ACCESS SYSTEMS, INC. ASZBS006

    Patients

    Seq Age Sex Outcome Treatment
    1