BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EZ-IO 25MM NEEDLE + STABILIZER BX/5 (NO)

    MDR report key: 11975774 · Received June 10, 2021

    Report

    Report Number
    3011137372-2021-00155
    Event Type
    Malfunction
    Date Received
    June 10, 2021
    Date of Event
    May 31, 2021
    Report Date
    May 31, 2021
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    FMI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    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. THE CUSTOMER RETURNED TWO PHOTOS FOR EVALUATION; REFERENCE (B)(4) AND (B)(4). THE FIRST PHOTO REVEALED A 25 MM NEEDLE WITH ITS GUARD LOOSE IN THE PACKAGE; A PUNCTURE MARK WAS PRESENT IN THE PACKAGING. THE SECOND DISPLAYED THE LIDSTOCK OF THE KIT. THE CUSTOMER RETURNED ONE EZ-IO 25 MM NEEDLE SET FOR EVALUATION. VISUAL INSPECTION OF THE UNOPENED KIT CONFIRMED THAT THE NEEDLE GUARD WAS COMPLETELY REMOVED FROM THE NEEDLE. THE NEEDLE WAS RETURNED PROTRUDING THOUGH THE PACKAGING, BREAKING THE STERILE BARRIER. THE KIT WAS OPENED, AND THE GUARD WAS REATTACHED TO THE NEEDLE AND FIT SNUG. THIS TIME THE GUARD REQUIRED MODERATE FORCE TO REMOVE. 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 09/2020 AND IS LESS THAN A YEAR OLD. A CAPA IS IN PROCESS TO FURTHER INVESTIGATE THE ISSUE OF THE NEEDLE COVER BECOMING DETACHED. INVESTIGATION OF THIS ISSUE WAS ALSO CONDUCTED UNDER RE-002830. 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 THE CUSTOMER PHOTOS. THE RETURNED UNOPENED KIT WAS CONFIRMED TO CONTAIN A NEEDLE WITH ITS GUARD COMPLETELY REMOVED FROM THE NEEDLE. THE NEEDLE TIP WAS PROTRUDING THROUGH THE PACKAGING BREAKING THE STERILE BARRIER. 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. INVESTIGATION OF THIS ISSUE WAS ALSO CONDUCTED UNDER RE-002830.

    Description of Event or Problem · 0

    TODAY WE RECEIVED A COMPLAINT FROM A CUSTOMER USING THE 9001P WHERE THEY FOUND A NEEDLE WITHOUT THE CAP. SIMILAR TO THE RECALL EIF-000372. THE CUSTOMER WAS STUNG BY THE NEEDLE WHEN CHECKING THEIR EQUIPMENT. THE CAP WAS FOUND IN THE PACKAGE. THE NEEDLE IS A 9001P-NO LOT 7256469 EXP.DATE 20240831.

    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

    TODAY WE RECEIVED A COMPLAINT FROM A CUSTOMER USING THE 9001P WHERE THEY FOUND A NEEDLE WITHOUT THE CAP. SIMILAR TO THE RECALL EIF-000372. THE CUSTOMER WAS STUNG BY THE NEEDLE WHEN CHECKING THEIR EQUIPMENT. THE CAP WAS FOUND IN THE PACKAGE. THE NEEDLE IS A 9001P-NO LOT 7256469 EXP.DATE 20240831.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    877210 EZ-IO 25MM NEEDLE + STABILIZER BX/5 (NO) FMI TELEFLEX MEDICAL IPN903858 7256469

    Patients

    Seq Age Sex Outcome Treatment
    1