BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EZ-IO 15MM NEEDLE SET + STABILIZER(BOX O

    MDR report key: 8566653 · Received April 30, 2019

    Report

    Report Number
    3011137372-2019-00142
    Event Type
    Malfunction
    Date Received
    April 30, 2019
    Date of Event
    April 23, 2019
    Report Date
    April 26, 2019
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    FMI
    PMA / PMN Number
    K101026
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THE DHR FILE IS NOT AVAILABLE FOR REVIEW IN THE US. THE ATTACHED CERTIFICATE OF COMPLIANCE CERTIFIES THAT THE AFOREMENTIONED LOT MEETS THE LAKE REGION MEDICAL QUALITY SYSTEM REQUIREMENTS AND SPECIFICATIONS. THIS PRODUCT HAS BEEN MANUFACTURED AND CONTROLLED BY LAKE REGION MEDICAL IN ACCORDANCE WITH THE FDA (B)(4) AND ISO (B)(4). EZ-IO NEEDLE SET, 9018P-VC-005 9058 (LOT# 6101635) WAS NEVER RETURNED TO TELEFLEX FOR INVESTIGATION PURPOSES. THE ROOT CAUSE CANNOT BE ESTABLISHED. THE COMPLAINT CANNOT BE CONFIRMED. NO FURTHER ACTION REQUIRED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHEN ATTEMPTING TO UNSCREW THE TOP APPARATUS TO DISCONNECT, TO CONNECT A T-CONNECTOR FOR MEDICATION ADMINISTRATION THE DEVICE WOULD NOT DISCONNECT.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HAS NOT BEEN RETURNED FOR INVESTIGATION. TELEFLEX WILL CONTINUE TO MONITOR AND TREND RELATED EVENTS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN ATTEMPTING TO UNSCREW THE TOP APPARATUS TO DISCONNECT, TO CONNECT A T-CONNECTOR FOR MEDICATION ADMINISTRATION THE DEVICE WOULD NOT DISCONNECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    359105 EZ-IO 15MM NEEDLE SET + STABILIZER(BOX O NEEDLE, HYPODERMIC, SINGLE LU FMI TELEFLEX MEDICAL 6101635

    Patients

    Seq Age Sex Outcome Treatment
    1