BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ISOVUE-300

    MDR report key: 521644 · Received April 19, 2004

    Report

    Report Number
    521644
    Event Type
    Malfunction
    Date Received
    April 19, 2004
    Date of Event
    February 1, 2004
    Report Date
    February 1, 2004
    Manufacturer
    BRACCO DIAGNOSTICS INC.
    Product Code
    FMF
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE TECHNICIAN NOTICED A FOREIGN PARTICLE FLOATING IN A [NEW] CONTAINER [(SYRINGE)] BEFORE PRODUCT COULD BE USED ON A PT. DEVICE USAGE PROBLEM: NOT KNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ISOVUE-300 150ML POWER INJECTOR SYRINGE FMF BRACCO DIAGNOSTICS INC. 1315-58 3H37381

    Patients

    Seq Age Sex Outcome Treatment
    1 *