BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KENDALL MONOJECT MAGELLAN

    MDR report key: 1183303 · Received October 2, 2008

    Report

    Report Number
    1183303
    Event Type
    Malfunction
    Date Received
    October 2, 2008
    Date of Event
    September 26, 2008
    Report Date
    October 2, 2008
    Manufacturer
    COVIDIEN (KENDALL)
    Product Code
    FMI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    WI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    SYRINGE APPEARED TO BE CONTAMINATED - DEBRIS COULD BE SEEN IN PACKAGING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KENDALL MONOJECT MAGELLAN NEEDLE, SAFETY FMI COVIDIEN (KENDALL) 25G X5/8" 819811

    Patients

    Seq Age Sex Outcome Treatment
    1 *