BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 11307623 · Received February 10, 2021

    Report

    Report Number
    3011137372-2021-00036
    Event Type
    Malfunction
    Date Received
    February 10, 2021
    Date of Event
    February 1, 2021
    Report Date
    February 1, 2021
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    FMI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 0

    QN# (B)(4). THE MANUFACTURING DHR FILES WERE REVIEWED. NO RECORDED RESULTS OF MANUFACTURING ISSUES OR ANOMALIES WERE REPORTED. THE CUSTOMER RETURNED FIVE PHOTOS FOR EVALUATION; (B)(4) FOR THE CUSTOMER PHOTOS. VISUAL INSPECTION OF THE PHOTOS CONFIRMED THE NEEDLE GUARD WAS REMOVED AND THERE APPEARED TO BE A HOLE IN THE KIT PACKAGING. THE CUSTOMER RETURNED ONE EZ-IO 15MM NEEDLE SET FOR EVALUATION. VISUAL INSPECTION OF THE UNOPENED KIT CONFIRMED THAT THE NEEDLE GUARD WAS REMOVED AND THE NEEDLE HAD POKED THROUGH THE PACKAGING. THIS FAILURE MODE IS LIKELY RELATED TO THE DESIGN OF THE KITS PACKAGING. 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 2 YEARS OLD. A CAPA IS IN PROCESS TO FURTHER INVESTIGATE THE ISSUE OF THE NEEDLE COVER BECOMING DETACHED. A EIF WAS ALSO INITIATED FOR THIS ISSUE. 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. THE RETURNED UNOPENED KIT WAS CONFIRMED TO CONTAIN A NEEDLE WITH ITS GUARD REMOVED AND THE NEEDLE HAD POKED THROUGH THE PACKAGING. 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. A EIF WAS ALSO INITIATED FOR THIS ISSUE.

    Description of Event or Problem · 0

    IT WAS REPORTED THE STERILE PACKAGING WAS DAMAGED. REASON: THE COVER ON THE NEEDLE IS MISSING OR HAS FALLEN OFF.

    Additional Manufacturer Narrative · 1

    QN#: (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 THE STERILE PACKAGING WAS DAMAGED. REASON: THE COVER ON THE NEEDLE IS MISSING OR HAS FALLEN OFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    208229 EZ-IO 15MM NEEDLE + STABILIZER BX/5 (EU) FMI TELEFLEX MEDICAL IPN033725 6363127

    Patients

    Seq Age Sex Outcome Treatment
    1