BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FASTLOAD MR SYRINGE PACK

    MDR report key: 20266310 · Received September 20, 2024

    Report

    Report Number
    20266310
    Event Type
    Malfunction
    Date Received
    September 20, 2024
    Date of Event
    September 4, 2024
    Report Date
    September 16, 2024
    Manufacturer
    BRACCO INJENEERING S.A
    Product Code
    IZQ
    UDI-DI
    17630039300866
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OH
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    FAULTY POWER INJECTOR SYRINGE-PLUNGER PORTION INSIDE OF SYRINGE TWISTED SIDEWAYS AFTER UNHOOKING FROM PATIENT. SALINE/CONTRAST LEAKED OUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1354000 FASTLOAD MR SYRINGE PACK INJECTOR, CONTRAST MEDIUM, AUTOMATIC IZQ BRACCO INJENEERING S.A 017356 256543 17630039300866

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown