BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AVANTA MANAGEMENT INJECTION

    MDR report key: 4289505 · Received November 17, 2014

    Report

    Report Number
    4289505
    Event Type
    Malfunction
    Date Received
    November 17, 2014
    Date of Event
    November 12, 2014
    Report Date
    November 17, 2014
    Manufacturer
    MEDRAD INC
    Product Code
    FPK
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MT, US

    Narratives

    Description of Event or Problem · 1

    DURING SET UP OF THE MEDRAD SYSTEM (THE MULTI PATIENT KIT) WHILE "FILLING" THE SYRINGE WITH CONTRAST, IT WAS NOTICED TO BE LEAKING AT THE TUBING SITE OR THE AREA OF THE STOPCOCK. THE TUBING WAS LEAKING. STAFF REMOVED THE LEAKING TUBING AND OBTAINED NEW TUBING FROM THE SAME LOT NUMBER. THE NEW TUBING WORKED JUST FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    743467 AVANTA MANAGEMENT INJECTION TUBING, FLUID DELIVERY FPK MEDRAD INC AVA 500 MPAT *

    Patients

    Seq Age Sex Outcome Treatment
    1 * NO PATIENT WAS INVOLVED DURING THIS EVENT