BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICROCLAVE

    MDR report key: 2073518 · Received April 20, 2011

    Report

    Report Number
    2073518
    Event Type
    Malfunction
    Date Received
    April 20, 2011
    Date of Event
    April 15, 2011
    Report Date
    April 20, 2011
    Manufacturer
    ICU MEDICAL, INC.
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US

    Narratives

    Description of Event or Problem · 1

    STAFF ATTEMPTED TO USE MICROCLAVE WHEN THE "TIP POPPED OUT UNDER PRESSURE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MICROCLAVE IV TUBING, CONNECTOR FPA ICU MEDICAL, INC. B3300 2159736

    Patients

    Seq Age Sex Outcome Treatment
    1 *