BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTRAST CONTROLLER-SPIKE ASSEMBLY

    MDR report key: 1920528 · Received November 14, 2010

    Report

    Report Number
    1920528
    Event Type
    Malfunction
    Date Received
    November 14, 2010
    Date of Event
    September 9, 2010
    Report Date
    November 13, 2010
    Manufacturer
    NAVILYST MEDICAL INC.
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US

    Narratives

    Description of Event or Problem · 1

    AFTER INJECTING CONTRAST IN FROM A 500CC BOTTLE IT WAS NOTED THAT IN THE CONTRAST AND IN THE CONTRAST SPIKE THAT CONTRAST SPIKE HAD FORMED WHITE PARTICULATES.A 125ML CONTRAST BOTTLE WAS THEN SPIKED AND WAS USED FOR ONE PROCEDURE. (NEW SPIKE AND NEW BOTTLE WERE UTILIZED) THE SAME WHITE PARTICULATES WERE ALSO SEEN.====================== HEALTH PROFESSIONAL'S IMPRESSION======================NOT APPLICABLE

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONTRAST CONTROLLER-SPIKE ASSEMBLY CONTRAST CONTROLLER-SPIKE ASSEMBLY FPA NAVILYST MEDICAL INC. NA 4054860
    2 37% ORGANICALLY BOUND IODINE; ISOVUE-370 37% ORGANICALLY BOUND IODINE; ISOVUE-370 KTA BRACCO DIAGNOSTICS * 0B50299
    3 37% ORGANICALLY BOUND IODINE 37% ORGANICALLY BOUND IODINE KTA BRACCO DIAGNOSTICS NA 9K38753

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR