BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MISI-MEDICAL IMAGING SOLUTIONS INTERNATIONAL

    MDR report key: 24188568 · Received January 27, 2026

    Report

    Report Number
    24188568
    Event Type
    Malfunction
    Date Received
    January 27, 2026
    Date of Event
    January 7, 2026
    Report Date
    January 14, 2026
    Manufacturer
    CANADIAN HOSPITAL SPECIALTIES LIMITED
    Product Code
    DXT
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    A POWER INJECTOR SYRINGE, ON THE CONTRAST SIDE OF THE CT INJECTOR, BROKE AT THE BASE DURING AN INJECTION. THE INJECTOR WAS PUSHING CONTRAST AT A RATE OF 4 ML/S. THE SYRINGE BROKE AFTER 25 ML WAS INJECTED DURING THE BOLUS TRACKING MONITORING PHASE OF THE EXAM. SOME FAINT SIGNS OF CONTRAST ARE VISIBLE IN THE IMAGES. THE PARTS WERE COLLECTED. THE INJECTOR WAS LOADED WITH NEW SYRINGES AND THE EXAM WAS SUCCESSFULLY COMPLETED. NO HARM TO PATIENT OR STAFF. THE PARTS WERE SEQUESTERED AND GIVEN TO CT SUPERVISOR TO RETAIN FOR POSSIBLE VENDOR INVESTIGATION (WAS NOT GIVEN TO RISK DEPT DUE TO CONTRAST STILL IN SYRINGE).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    249984 MISI-MEDICAL IMAGING SOLUTIONS INTERNATIONAL INJECTOR AND SYRINGE, ANGIOGRAPHIC DXT CANADIAN HOSPITAL SPECIALTIES LIMITED 400109 208645

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Female