BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EZ-IO

    MDR report key: 3480403 · Received November 14, 2013

    Report

    Report Number
    3480403
    Event Type
    Malfunction
    Date Received
    November 14, 2013
    Date of Event
    November 11, 2013
    Report Date
    November 14, 2013
    Manufacturer
    VIDACARE CORPORATION
    Product Code
    FMI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    RI, US

    Narratives

    Description of Event or Problem · 1

    AFTER INSERTION OF 15 GAUGE EZ-IO NEEDLE, RN ATTEMPTED TO REMOVE STYLET AND UPON VISUAL INSPECTION FOUND THAT STYLET HAD BROKEN OFF FROM NEEDLE. NEEDLE REMAINED IN PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    590958 EZ-IO NEEDLE FMI VIDACARE CORPORATION 9001 AV12L01

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR