BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FASTLOAD CTA DUAL SYRINGE PACK

    MDR report key: 20075095 · Received August 27, 2024

    Report

    Report Number
    20075095
    Event Type
    Malfunction
    Date Received
    August 27, 2024
    Date of Event
    August 19, 2024
    Report Date
    August 20, 2024
    Manufacturer
    BRACCO INJENEERING S.A.
    Product Code
    DXT
    UDI-DI
    17630039300880
    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

    ELDERLY FEMALE WITH RECENT BLURRED VISION AND PARESTHESIA. PROCEDURE: CT HEAD. SCAN COW (CIRCLE OF WILLIS)/CAROTID AND TIMING BOLUS WAS FAINT AND HARD TO DETERMINE ON SCREEN. OBSERVATION IN SCAN ROOM IDENTIFIED MINIMAL AMOUNT OF CONTRAST GOT TO PATIENT, THE MAJORITY OF THE CONTRAST WAS ON THE FLOOR. LEAK OF CONTRAST FROM TUBING SITE OR CONNECTION UNIDENTIFIED. PATIENT RECEIVED A RELOAD OF CONTRAST AND AN ADDITIONAL 20CC AND ADMINISTERED ANOTHER TIMING BOLUS. NO KNOWN HARM TO PATIENT BUT DELAY IN PATIENT CARE. MANUFACTURER RESPONSE FOR INJECTOR AND SYRINGE, ANGIOGRAPHIC, FASTLOAD CTA DUAL SYRINGE PACK (PER SITE REPORTER), WILL OBTAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    29444 FASTLOAD CTA DUAL SYRINGE PACK INJECTOR AND SYRINGE, ANGIOGRAPHIC DXT BRACCO INJENEERING S.A. 017354 257836 17630039300880

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Female