BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EZ-IO 15MM NEEDLE + STABILIZER BX/5 (EU)

    MDR report key: 12613874 · Received October 12, 2021

    Report

    Report Number
    3011137372-2021-00281
    Event Type
    Malfunction
    Date Received
    October 12, 2021
    Date of Event
    October 4, 2021
    Report Date
    October 4, 2021
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    FMI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    (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 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/DEVICE HISTORY RECORD FOUND THAT THE NEEDLE SET PASSED ALL THE RELEASE CRITERIA. THE DEVICE WAS RELEASED IN 12/2018 AND IS APPROXIMATELY 3 YEARS OLD. THE COMPLAINT SAMPLE IS NOT AVAILABLE FOR RETURN. FUNCTIONAL TESTING AND INVESTIGATION ACTIVITIES CANNOT BE CONDUCTED. THE COMPLAINT ROOT CAUSE CANNOT BE ESTABLISHED. THE COMPLAINT CANNOT BE CONFIRMED. NO CORRECTIVE/PREVENTATIVE ACTIONS WILL BE ASSIGNED.

    Description of Event or Problem · 0

    DURING INCOMING GOODS INSPECTION/INVENTORY CHECK - CAP NO LONGER ON THE NEEDLE AS A RESULT OF PIERCING THE OUTER PACKAGING.

    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

    DURING INCOMING GOODS INSPECTION/INVENTORY CHECK - CAP NO LONGER ON THE NEEDLE AS A RESULT OF PIERCING THE OUTER PACKAGING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1518262 EZ-IO 15MM NEEDLE + STABILIZER BX/5 (EU) FMI TELEFLEX MEDICAL IPN033725 6332450

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown