BEUDAMED
    FDA Adverse Event Injury Summary report: N

    E-Z IO - HYPODERMIC NEEDLE

    MDR report key: 5367892 · Received January 11, 2016

    Report

    Report Number
    MW5059341
    Event Type
    Injury
    Date Received
    January 11, 2016
    Date of Event
    October 6, 2015
    Report Date
    January 11, 2016
    Manufacturer
    VIDACARE CORPORATION
    Product Code
    FMI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TN, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT PRESENTED TO THE ER ON (B)(6) 2015. INTRAOSSEOUS DEVICE INSERTED BY THE ER PHYSICIAN. PT ADMITTED AND THE FLOOR NURSE NOTED THAT THE INTRAOSSEOUS DEVICE WAS LEAKING. THE NURSE REQUESTED ASSISTANCE IN REMOVAL BY THE ER STAFF. THE ER NURSE CAME TO REMOVE THE IO AND NOTED THAT THE DEVICE WAS ALREADY OUT AND WAS ATTACHED TO THE GAUZE. THE PT WAS DISCHARGED AND RETURNED ON (B)(6) 2015 COMPLAINING OF SHOULDER PAIN. AN X-RAY WAS OBTAINED AND SHOWED THAT A 2CM LINEAR FOREIGN OBJECT NOTED ON X-RAY WITH WHAT APPEARED TO HAVE A SEGMENT OF A CATHETER REMAINING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    18212 E-Z IO - HYPODERMIC NEEDLE E-Z IO - HYPODERMIC NEEDLE FMI VIDACARE CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Required Intervention