BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FASTLOAD CTA DUAL SYRINGE PACK

    MDR report key: 19380388 · Received May 23, 2024

    Report

    Report Number
    19380388
    Event Type
    Malfunction
    Date Received
    May 23, 2024
    Date of Event
    April 30, 2024
    Report Date
    May 3, 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

    PROCEDURE: CT- BRACCO INJECTORS LOT#: 251454, INJECTORS OBTAINED TUBING CRACKS WHILE INJECTING, CONTRAST LEAKED ALL OVER. TUBES WERE NOT SAVED- NO KNOWN HARM TO STAFF OR PATIENT. PROCEDURE 2: CT- BRACCO INJECTOR TOP IS BROKEN OFF AND UNABLE TO LOAD CONTRAST IMMEDIATELY AFTER REMOVING FROM PACKAGING. NOT USED ON PATIENT. TUBES SAVED, PACKAGING NOT. MANUFACTURER RESPONSE FOR INJECTOR AND SYRINGE, ANGIOGRAPHIC, FASTLOAD CTA DUAL SYRINGE PACK (PER SITE REPORTER). ONSITE AT MAIN CAMPUS REVIEWING POSSIBLE ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1789327 FASTLOAD CTA DUAL SYRINGE PACK INJECTOR AND SYRINGE, ANGIOGRAPHIC DXT BRACCO INJENEERING S.A. 017354 251454 17630039300880

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown