BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AVANTA

    MDR report key: 2466887 · Received February 16, 2012

    Report

    Report Number
    2466887
    Event Type
    Malfunction
    Date Received
    February 16, 2012
    Date of Event
    February 15, 2012
    Report Date
    February 16, 2012
    Manufacturer
    MEDRAD, INC.
    Product Code
    DXT
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MT, US

    Narratives

    Description of Event or Problem · 1

    DEFECTIVE, MEDRAD MUTIPATIENT DISPOSABLE SET, VENT CAP POPPED OFF WHEN CHANGING OUT THE CONTRAST. UNABLE TO USE THE DEVICE, HAD TO REPLACE AND USE ANOTHER DEVICE OUT OF THE SAME LOT NUMBER. PATIENT WAS NOT HARMED, BUT CASE WAS DELAYED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AVANTA SYRINGE, CONTRAST INJECTION DXT MEDRAD, INC. AVA 500 MPAT 113503

    Patients

    Seq Age Sex Outcome Treatment
    1 *