BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EZ-IO 45MM NEEDLE SET + STABILIZER(BOX O

    MDR report key: 11684648 · Received April 19, 2021

    Report

    Report Number
    3011137372-2021-00094
    Event Type
    Malfunction
    Date Received
    April 19, 2021
    Date of Event
    March 25, 2021
    Report Date
    March 25, 2021
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    FMI
    UDI-DI
    10801902170634
    PMA / PMN Number
    K091140
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    QN# (B)(4). THE MANUFACTURING DHR FILE WAS REVIEWED. NO RECORDED RESULTS OF MANUFACTURING ISSUES OR ANOMALIES WERE REPORTED. CERTIFICATE OF COMPLIANCE (PART OF DHR) CERTIFIES THAT THE AFOREMENTIONED LOT MEETS THE VIANT UPLAND (FORMERLY LAKE REGION MEDICAL) QUALITY SYSTEM REQUIREMENTS AND SPECIFICATIONS. THIS PRODUCT HAS BEEN MANUFACTURED AND CONTROLLED BY VIANT UPLAND IN ACCORDANCE WITH THE FDA QSR AND ISO ISO13485:2016. A REVIEW OF THE CERTIFICATE OF CONFORMANCE AND DEVICE HISTORY RECORD FOUND THAT THE NEEDLE SET PASSED ALL THE RELEASE CRITERIA. THE DEVICE WAS MANUFACTURED IN 01/2018 AND IS APPROXIMATELY 3.5 YEARS OLD. THE COMPLAINT SAMPLE WAS NEVER RETURNED TO TELEFLEX FOR INVESTIGATION PURPOSES. THE COMPLAINT ROOT CAUSE CANNOT BE ESTABLISHED. THE COMPLAINT CANNOT BE CONFIRMED. THE COMPLAINT SAMPLE WAS NEVER RETURNED TO TELEFLEX FOR INVESTIGATION PURPOSES. THE COMPLAINT ROOT CAUSE CANNOT BE ESTABLISHED. THE COMPLAINT CANNOT BE CONFIRMED.

    Description of Event or Problem · 0

    AFTER IO NEEDLE INSERTED, THE PATIENT WAS TRANSFERRED BACK TO WARD AND THE HEAD NURSE FOUND THE NEEDLE WAS SEPARATED FROM THE HUB. THE NEEDLE WAS REMOVED BY AN ORTHOPEDICS PHYSICIAN.

    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

    AFTER IO NEEDLE INSERTED, THE PATIENT WAS TRANSFERRED BACK TO WARD AND THE HEAD NURSE FOUND THE NEEDLE WAS SEPARATED FROM THE HUB. THE NEEDLE WAS REMOVED BY AN ORTHOPEDICS PHYSICIAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    582436 EZ-IO 45MM NEEDLE SET + STABILIZER(BOX O NEEDLE, HYPODERMIC, SINGLE LU FMI TELEFLEX MEDICAL IPN917347 5988828 10801902170634

    Patients

    Seq Age Sex Outcome Treatment
    1