BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EZ-IO 25MM NEEDLE (BOX OF 5)

    MDR report key: 10942150 · Received December 3, 2020

    Report

    Report Number
    3011137372-2020-00267
    Event Type
    Malfunction
    Date Received
    December 3, 2020
    Date of Event
    September 29, 2020
    Report Date
    November 13, 2020
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    FMI
    PMA / PMN Number
    K091140
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (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 LOT BASED ON SALES HISTORY MEETS THE LAKE REGION MEDICAL (VIANT) QUALITY SYSTEM REQUIREMENTS AND SPECIFICATIONS. THIS PRODUCT HAS BEEN MANUFACTURED AND CONTROLLED BY LAKE REGION MEDICAL (VIANT) IN ACCORDANCE WITH THE FDA QSR AND ISO (B)(4). 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 03/2018 AND IS APPROXIMATELY 3 YEARS OLD. THE COMPLAINT SAMPLE IS NOT AVAILABLE FOR RETURN. FUNCTIONAL TESTING AND INVESTIGATION ACTIVITIES CANNOT BE CONDUCTED. THE COMPLAINT ROOT CAUSE CANNOT BE ESTABLISHED. THE COMPLAINT CANNOT BE CONFIRMED. NO CORRECTIVE/PREVENTATIVE ACTIONS WILL BE ASSIGNED.

    Description of Event or Problem · 0

    REPORTED ISSUE: CAPTAIN TRIED TO INSERT A TIBIAL IO ON A PATIENT. THE NEEDLE AND STYLET WERE FUSED TOGETHER. THEY ENDED UP USING A PIV TO GAIN ACCESS.

    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

    REPORTED ISSUE: CAPTAIN TRIED TO INSERT A TIBIAL IO ON A PATIENT. THE NEEDLE AND STYLET WERE FUSED TOGETHER. THEY ENDED UP USING A PIV TO GAIN ACCESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1407472 EZ-IO 25MM NEEDLE (BOX OF 5) NEEDLE, HYPODERMIC, SINGLE LU FMI TELEFLEX MEDICAL UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1