BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAGELLAN 25G 1 INCH NEEDLE

    MDR report key: 8069003 · Received November 13, 2018

    Report

    Report Number
    MW5081193
    Event Type
    Malfunction
    Date Received
    November 13, 2018
    Date of Event
    November 6, 2018
    Report Date
    November 7, 2018
    Manufacturer
    COVIDIEN / CARDINAL HEALTH 200, LLC
    Product Code
    FMI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    FIBER FOUND ON NEEDLE. PACKAGE WAS SEALED PRIOR TO INSPECTION. PRODUCT: SAFETY NEEDLE 25G 1 INCH MAGELLAN, MFR: COVIDIEN, LOT: 820844, EXP: 06/20/2023.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    905594 MAGELLAN 25G 1 INCH NEEDLE NEEDLE, HYPODERMIC, SINGLE LUMEN FMI COVIDIEN / CARDINAL HEALTH 200, LLC 820844

    Patients

    Seq Age Sex Outcome Treatment
    0