BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EZ-IO 45MM NEEDLE + STABILIZER BX/5 (EU)

    MDR report key: 11770675 · Received May 4, 2021

    Report

    Report Number
    3011137372-2021-00133
    Event Type
    Malfunction
    Date Received
    May 4, 2021
    Date of Event
    April 23, 2021
    Report Date
    April 23, 2021
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    FMI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    RISK MANAGER

    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 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 06/2020 AND IS APPROXIMATELY 1 YEAR OLD. A CAPA IS IN PROCESS TO FURTHER INVESTIGATE THE ISSUE OF THE NEEDLE COVER BECOMING DETACHED. THE COMPLAINT OF A GUARD BECOMING REMOVED FROM ITS NEEDLE WHILE STILL IN THE KIT WAS ABLE TO BE CONFIRMED BY A COMPLAINT INVESTIGATION OF THE RETURNED SAMPLE AND CUSTOMER PHOTOS. WHEN THE RETURNED KIT WAS OPENED, IT WAS CONFIRMED TO CONTAIN A NEEDLE WITH ITS GUARD NOT FULLY SECURE TO THE NEEDLE. THE LIKELY CAUSE OF THIS COMPLAINT IS THE PACKAGE DESIGN. A CAPA IS IN PROCESS TO FURTHER INVESTIGATE THE ISSUE OF THE NEEDLE GUARD BECOMING DETACHED.

    Description of Event or Problem · 0

    DETACHED NEEDLE CAP; FOUND ON ROUTINELY CHECK-UPS.

    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

    DETACHED NEEDLE CAP; FOUND ON ROUTINELY CHECK-UPS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    670414 EZ-IO 45MM NEEDLE + STABILIZER BX/5 (EU) FMI TELEFLEX MEDICAL IPN033763 6899596

    Patients

    Seq Age Sex Outcome Treatment
    1