BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIDACARE EZ IO

    MDR report key: 3034380 · Received March 28, 2013

    Report

    Report Number
    3034380
    Event Type
    Malfunction
    Date Received
    March 28, 2013
    Date of Event
    March 23, 2013
    Report Date
    March 28, 2013
    Manufacturer
    VIDACARE CORPORATION
    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

    EZ IO HUB BROKE WHEN ATTEMPTING TO D/C THE DEVICE FROM RIGHT TIBIA PER MANUFACTURER'S RECOMMENDATION. EXTRACTION OF THE NEEDLE FROM THE TIBIA WAS DONE VIA STERILE HEMOSTAT WITH MODERATE DIFFICULTY. NEEDLE APPEARED TO BE INTACT AND THERE WERE NO FURTHER COMPLICATIONS.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?DISCONTINUATION/REMOVAL OF THE EZ IO VASCULAR ACCESS SYSTEM FROM THE PATIENT.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    128569 VIDACARE EZ IO NEEDLE, HYPODERMIC, SINGLE LUMEN FMI VIDACARE CORPORATION 9001 AV10H02

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR