BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 11581097 · Received March 29, 2021

    Report

    Report Number
    3011137372-2021-00070
    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

    (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). THE CUSTOMER RETURNED ONE EZ-IO 15MM NEEDLE SET FOR EVALUATION. VISUAL INSPECTION OF THE UNOPENED KIT CONFIRMED THAT THE NEEDLE GUARD WAS REMOVED. THE NEEDLE WAS NOT PROTRUDING THROUGH THE PACKAGING WHEN THE SAMPLE WAS RETURNED, BUT A HOLE WAS ALSO NOTED IN THE PACKAGING AT THE LOCATION OF THE NEEDLE TIP. THIS FAILURE MODE IS LIKELY RELATED TO THE DESIGN OF THE KITS PACKAGING. 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 NEEDLE WAS NOT PROTRUDING THROUGH THE PACKAGING WHEN THE SAMPLE WAS RETURNED, BUT A HOLE WAS ALSO NOTED IN THE PACKAGING AT THE LOCATION OF THE NEEDLE TIP. THE LIKELY CAUSE OF THIS COMPLAINT IS THE PACKAGE DESIGN. CAPA 165 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 POTECTIVE CAP HAS COME OFF, THE NEEDLE IS EXPOSED IN THE PACKAGING, THE NEEDLE HAS PUNCTURED THE PACKAGING. IT WAS CONFIRMED THAT 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, THE NEEDLE IS EXPOSED IN THE PACKAGING, THE NEEDLE HAS PUNCTURED THE PACKAGING. IT WAS CONFIRMED THAT THERE WAS NO INJURY TO STAFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    484034 EZ-IO 15MM NEEDLE + STABILIZER BX/5 (EU) FMI TELEFLEX MEDICAL IPN033725 6715163

    Patients

    Seq Age Sex Outcome Treatment
    1