BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MISI-MEDICAL IMAGING SOLUTIONS INTERNATIONAL

    MDR report key: 23973834 · Received January 6, 2026

    Report

    Report Number
    23973834
    Event Type
    Malfunction
    Date Received
    January 6, 2026
    Date of Event
    December 3, 2025
    Report Date
    December 9, 2025
    Manufacturer
    CANADIAN HOSPITAL SPECIALTIES LIMITED
    Product Code
    DXT
    UDI-DI
    00628725095141
    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

    CT SCAN INJECTOR SYRINGE BROKE WHILE INITIALIZING AND MADE A POPPING SOUND. NOT USED ON A PATIENT. STERILE SALINE WAS IN THE SYRINGE. SYRINGE WAS REMOVED AND CHECKED AREA FOR BROKEN PARTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    33062 MISI-MEDICAL IMAGING SOLUTIONS INTERNATIONAL INJECTOR AND SYRINGE, ANGIOGRAPHIC DXT CANADIAN HOSPITAL SPECIALTIES LIMITED 400109 208676 00628725095141

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown