BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COEUR MEDICAL

    MDR report key: 1840835 · Received September 3, 2010

    Report

    Report Number
    1840835
    Event Type
    Malfunction
    Date Received
    September 3, 2010
    Date of Event
    August 23, 2010
    Report Date
    September 2, 2010
    Manufacturer
    COEUR, INC.
    Product Code
    FMF
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    KY, US

    Narratives

    Description of Event or Problem · 1

    PLUNGER TABS BROKE AND PLUNGER TURNED COCK-EYED SPILLING CONTRAST.====================== HEALTH PROFESSIONAL'S IMPRESSION======================THERE WAS NOT AN ADVERSE EVENT REGARDING A PATIENT, BUT POTENTIAL DAMAGE TO EQUIPMENT AND A POSSIBLE DELAY IN PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COEUR MEDICAL SYRINGE FMF COEUR, INC. 77-400250 60310127

    Patients

    Seq Age Sex Outcome Treatment
    1 *