BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KENDALL MONOJECT MAGELLAN 3ML SYRINGE WITH SAFETY

    MDR report key: 1902943 · Received November 12, 2010

    Report

    Report Number
    MW5018226
    Event Type
    Malfunction
    Date Received
    November 12, 2010
    Date of Event
    October 26, 2010
    Report Date
    November 12, 2010
    Manufacturer
    COVIDIEN
    Product Code
    FMF
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    NURSE WAS GIVING AN INTRAMUSCULAR SHOT TO THIS PT IN HIS RIGHT GLUTEUS MAXIMUS MUSCLE. NURSE HEARD A LOUD POP, PULLED THE NEEDLE OUT IMMEDIATELY, INSPECTED NEEDLE, NEEDLE INTACT BUT SMALL BLUE PLASTIC PART BROKEN WHERE NEEDLE CONNECTS TO SYRINGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KENDALL MONOJECT MAGELLAN 3ML SYRINGE WITH SAFETY 3 ML NEEDLE FMF COVIDIEN 8881833310

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR