BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EZ-IO POWER DRIVER

    MDR report key: 8281827 · Received January 28, 2019

    Report

    Report Number
    3011137372-2019-00009
    Event Type
    Injury
    Date Received
    January 28, 2019
    Date of Event
    December 17, 2018
    Report Date
    January 6, 2019
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    FMI
    PMA / PMN Number
    K141117
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE REPORTED ISSUE CAME FROM AN ARTICLE REVIEW AND THE DEVICE RETURN IS NOT EXPECTED. TELEFLEX WILL CONTINUE TO MONITOR AND TREND RELATED EVENTS.

    Description of Event or Problem · 1

    CHALOPIN T, LEMAIGNEN A, GUILLON A, ET AL. ACUTE TIBIAL OSTEOMYELITIS CAUSED BY INTRAOSSEOUS ACCESS DURING INITIAL RESUSCITATION: A CASE REPORT AND LITERATURE REVIEW. BMC INFECTIOUS DISEASES 2018;18(1):665. DOI: 10.1186/S12879-018-3577-8. THIS REPORT FROM FRANCE REPORTS A CASE OF TIBIAL OSTEOMYELITIS IN A (B)(6) DRUG ADDICTED MALE THAT WAS DIAGNOSED BY MRI AND BIOPSY THREE MONTHS POST-INTRAOSSEOUS (IO) CATHETER REMOVAL. THE PATIENT WAS GIVEN PARENTERAL AS WELL AS ORAL ANTIBIOTICS AND HAD A GOOD OUTCOME. THE INITIAL IO CATHETER PLACEMENT WAS FOR TREATMENT OF OVERDOSE AFTER FAILED IV ATTEMPTS. THE CATHETER WAS REMOVED ON THE FIRST DAY AND THE PATIENT WAS TREATED WITH ORAL ANTIBIOTICS DUE TO LOCAL INFLAMMATION AT THE INSERTION SITE. HE LEFT AGAINST MEDICAL ADVICE BEFORE A FULL TREATMENT COURSE WAS COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    74085 EZ-IO POWER DRIVER NEEDLE, HYPODERMIC, SINGLE LU FMI TELEFLEX MEDICAL

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Required Intervention