BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AVANTA

    MDR report key: 2867221 · Received October 1, 2012

    Report

    Report Number
    2867221
    Event Type
    Malfunction
    Date Received
    October 1, 2012
    Date of Event
    September 21, 2012
    Report Date
    October 1, 2012
    Manufacturer
    MEDRAD INTERNATIONAL
    Product Code
    DXT
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MT, US

    Narratives

    Description of Event or Problem · 1

    CONTRAST IN THE MULTI-PATIENT MEDRAD SET UP WAS NOTICED TO BE CLOUDY IN APPEARANCE. THERE WERE ONLY 4 CASES IN LESS THAN A 10 HOUR PERIOD. FIVE CASES CAN BE DONE IN A 10 HOUR PERIOD AS RECOMMENDED BY COMPANY. POSSIBLE FAULTY SYRINGE DUE TO THE CONTRAST HARDENING AND TURNING CLOUDY ON THE END OF TUBING THAT LEADS TO THE SYRINGE, THE OTHER END OF THE TUBING FROM THE BOTTLE WAS STILL LIQUID. NO PATIENT WAS AFFECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AVANTA MULTI-PATIENT DISPOSABLE KIT DXT MEDRAD INTERNATIONAL ASA 500 MPAT 126264-/115202

    Patients

    Seq Age Sex Outcome Treatment
    1 *