BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 11581104 · Received March 29, 2021

    Report

    Report Number
    3011137372-2021-00069
    Event Type
    Malfunction
    Date Received
    March 29, 2021
    Date of Event
    March 10, 2021
    Report Date
    March 10, 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 FILES WERE REVIEWED. NO RECORDED RESULTS OF MANUFACTURING ISSUES OR ANOMALIES WERE REPORTED. THE CUSTOMER RETURNED THREE PHOTOS FOR EVALUATION, TWO PHOTOS OF THE LIDSTOCK AND ONE PHOTO OF A 15 MM NEEDLE STILL IN ITS PACKAGING. THE PHOTO OF THE NEEDLE CONFIRMED THAT THE NEEDLE GUARD HAD COME OFF PREMATURELY. REFERENCE (B)(4) AND (B)(4). THE CUSTOMER RETURNED ONE EZ-IO 15MM NEEDLE SET FOR EVALUATION. VISUAL INSPECTION OF THE UNOPENED KIT CONFIRMED THAT THE NEEDLE GUARD WAS REMOVED. THERE WERE NO HOLES OBSERVED IN THE PACKAGING; THE STERILE BARRIER WAS NOT COMPROMISED. THIS FAILURE MODE IS LIKELY RELATED TO THE DESIGN OF THE KITS PACKAGING. REFERENCE (B)(4) FOR INVESTIGATION PHOTOS. THE ATTACHED CERTIFICATE OF COMPLIANCE (PART OF DHR) CERTIFIES THAT THE AFOREMENTIONED LOT MEETS THE VIANT QUALITY SYSTEM REQUIREMENTS AND SPECIFICATIONS. THIS PRODUCT HAS BEEN MANUFACTURED AND CONTROLLED BY VIANT IN ACCORDANCE WITH THE FDA QSR AND ISO 13485:2016. 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 (B)(6) 2020 AND IS LESS THAN A YEAR OLD. A CAPA IS IN PROCESS TO FURTHER INVESTIGATE THE ISSUE OF THE NEEDLE COVER BECOMING DETACHED. EIF-000466 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 AND CUSTOMER PHOTOS. THE RETURNED UNOPENED KIT WAS CONFIRMED TO CONTAIN A NEEDLE WITH ITS GUARD REMOVED. 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. EIF-000466 WAS ALSO INITIATED FOR THIS ISSUE.

    Description of Event or Problem · 0

    THE PROTECTIVE CAP HAS COME OFF, PROTECTIVE CAP IS MOVEABLE, THE PROTECTIVE CAP IS STILL ON THE NEEDLE IN THE PACKAGING. IT WAS CONFIRMED THAT THE NEEDLE DID NOT PUNCTURE THE PACKAGING AND THERE WAS NO INJURY TO STAFF.

    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

    THE PROTECTIVE CAP HAS COME OFF, PROTECTIVE CAP IS MOVEABLE, THE PROTECTIVE CAP IS STILL ON THE NEEDLE IN THE PACKAGING. IT WAS CONFIRMED THAT THE NEEDLE DID NOT PUNCTURE THE PACKAGING AND THERE WAS NO INJURY TO STAFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    483956 EZ-IO 15MM NEEDLE + STABILIZER BX/5 (EU) FMI TELEFLEX MEDICAL IPN033725 7256489

    Patients

    Seq Age Sex Outcome Treatment
    1