BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAGELLAN

    MDR report key: 3961012 · Received July 22, 2014

    Report

    Report Number
    MW5037428
    Event Type
    Malfunction
    Date Received
    July 22, 2014
    Date of Event
    July 21, 2014
    Report Date
    July 21, 2014
    Manufacturer
    COVIDIEN
    Product Code
    FMI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OH, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    WE SWITCHED TO THIS BRAND OF INSULIN SYRINGES ABOUT A YEAR AGO. SINCE THAT TIME OUR STAFF HAS NOTICED AN INCREASE IN THE NUMBER OF NEEDLESTICKS CAUSED BY THE NEEDLES PUNCTURING THE ORANGE CAPS WHEN RECAPPING THE NEEDLE AFTER DRAWING UP A DOSE. STAFF MEMBERS ATTRIBUTE THIS TO A SOFTER PLASTIC IN THE COVIDIEN MAGELLAN SYRINGES. CAN A HARDER PLASTIC BE USED?

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    429077 MAGELLAN INSULIN SYRINGE 1/2 ML FMI COVIDIEN MAGELLAN 411338X
    429078 MAGELLAN INSULIN SYRINGE 1ML FMI COVIDIEN MAGELLAN

    Patients

    Seq Age Sex Outcome Treatment
    1