BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STELLANT STERILE DISPOSABLE SYRINGE

    MDR report key: 3866704 · Received June 5, 2014

    Report

    Report Number
    MW5036491
    Event Type
    Malfunction
    Date Received
    June 5, 2014
    Date of Event
    May 27, 2014
    Report Date
    May 29, 2014
    Manufacturer
    MEDRAD, INC.
    Product Code
    FMF
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    KY, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    MEDRAD STELLANT SYRINGE BROKE, THE TOP TWISTED CLOSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    328845 STELLANT STERILE DISPOSABLE SYRINGE DISPOSABLE SYRINGE FMF MEDRAD, INC. 163710

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR