BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COVIDIEN

    MDR report key: 4342846 · Received December 11, 2014

    Report

    Report Number
    MW5039639
    Event Type
    Malfunction
    Date Received
    December 11, 2014
    Date of Event
    September 3, 2014
    Report Date
    October 10, 2014
    Manufacturer
    COVIDIEN
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    NEEDLE COUNTER (X2) INSIDE KIT WERE FOUND BROKEN ON OPENING THE KIT. (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    803933 COVIDIEN PENCIL BUTTON WITH HOLSTER/NEEDLE COUNTER #1820 GEI COVIDIEN 3220100764X
    803934 COVIDIEN PENCIL BUTTON WITH HOLSTER/NEEDLE COUNTER #1820 --- COVIDIEN 3220100764X

    Patients

    Seq Age Sex Outcome Treatment
    1