BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EZ-IO

    MDR report key: 3855621 · Received April 14, 2014

    Report

    Report Number
    3004526033-2014-00003
    Event Type
    Malfunction
    Date Received
    April 14, 2014
    Date of Event
    February 28, 2014
    Report Date
    April 8, 2014
    Manufacturer
    VIDACARE CORPORATION
    Product Code
    FMI
    PMA / PMN Number
    K032885
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE USER REPORTED THAT THE PRODUCT PERFORMED ACCORDING TO SPECIFICATION UNTIL THE REMOVAL PROCESS WHEN THE CANNULA BROKE OFF BELOW THE CORTEX OF THE BONE. THE CANNULA BREAKING WAS MOSTLY THE RESULT OF POOR REMOVAL TECHNIQUE. THIS REPORT IS BEING SUBMITTED BECAUSE THE ATTENDING PHYSICIAN DECIDED TO LEAVE THE STAINLESS STEEL IN THE PT RATHER THAN RETRIEVE THE REMNANT. THE CANNULA INVOLVED IN THE INCIDENT IS BEING RETURNED FOR EVALUATION AND A SUBSEQUENT REPORT WILL BE FILED ONCE AN EVALUATION OF THE RETURNED DEVICE IS COMPLETED.

    Description of Event or Problem · 1

    DURING REMOVAL OF A 45MM EZ-IO CANNULA THE STAINLESS STEEL CANNULA BROKE LEAVING A PORTION OF THE NEEDLE SET IN THE PT. XRAY SHOWED IT WAS BELOW CORTEX SO NOT RETRIEVABLE WITHOUT OPERATIVE INTERVENTION. PT WAS NEAR QUADRIPLEGIC AND HAD NO/LITTLE USE OF HIS ARMS. AN ORTHOPEDIC SURGEON WAS CONSULTED AND IT WAS DECIDED TO LEAVE THE NEEDLE IN THE BONE. THE PT WAS DISCHARGED WITH NO COMPLAINTS, PAIN, OR SEQUELA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    228250 EZ-IO INTRAOSSEOUS NEEDLE FMI VIDACARE CORPORATION 9079

    Patients

    Seq Age Sex Outcome Treatment
    1 Other