BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BAYER MEDICAL CARE, INC.

    MDR report key: 6016867 · Received October 7, 2016

    Report

    Report Number
    MW5065268
    Event Type
    Malfunction
    Date Received
    October 7, 2016
    Date of Event
    September 7, 2016
    Report Date
    September 29, 2016
    Manufacturer
    BAYER MEDICAL CARE, INC.
    Product Code
    DXT
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    KY, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    CONTRAST SYRINGE SEALED CLOSED BY SPIKE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    663656 BAYER MEDICAL CARE, INC. MEDRAD STELLANT DXT BAYER MEDICAL CARE, INC. 8521218

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR