BEUDAMED
    FDA Adverse Event Other Summary report: N

    EZ-IO

    MDR report key: 2217353 · Received July 11, 2011

    Report

    Report Number
    3004526033-2011-00002
    Event Type
    Other
    Date Received
    July 11, 2011
    Date of Event
    June 11, 2011
    Report Date
    July 11, 2011
    Manufacturer
    VIDACARE CORPORATION
    Product Code
    FMI
    PMA / PMN Number
    K032885
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MOST LIKELY CAUSE FOR ADDITIONAL SURGICAL PROCEDURE TO REMOVE CANNULA WAS POOR INITIAL CANNULA REMOVAL TECHNIQUE.

    Description of Event or Problem · 1

    EZ-IO INSERTED IN PROXIMAL TIBIA IN THE EMERGENCY DEPARTMENT. DURING REMOVAL, IO CANNULA BROKE AT HUB. ATTEMPTS TO REMOVE WITH PLIERS AND HEMOSTATS RESULTED IN CANNULA BEING BROKEN OFF BELOW SKIN SURFACE. CANNULA REMOVAL REQUIRED SURGICAL INTERVENTION TO COMPLETELY EXCISE CANNULA. PATIENT SUFFERED NO ADDITIONAL COMPLICATION AFTER SURGICAL REMOVAL OF THE CANNULA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EZ-IO INTRAOSSEUS NEEDLE SET FMI FMI VIDACARE CORPORATION 25MM 15GA IO NEEDLE AV11B02

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Required Intervention