BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDICAL IMAGING SOLUTIONS INTL.

    MDR report key: 23389903 · Received October 27, 2025

    Report

    Report Number
    23389903
    Event Type
    Malfunction
    Date Received
    October 27, 2025
    Date of Event
    April 21, 2025
    Report Date
    September 29, 2025
    Manufacturer
    CANADIAN HOSPITAL SPECIALTIES LTD
    Product Code
    DXT
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    WE WERE INFORMED BY THE MANAGER OF RADIOLOGY AT [REDACTED] THAT CT INJECTOR SYRINGES HAD CONDENSATION. HE LISTED AFFECTED LOT #2503333, 2503336, 2503339. I OPENED ONE SET OF SYRINGE PACKAGING (LOT # 2503333) AND THERE IS EVIDENCE OF CONDENSATION. I PULLED THE TWO CASES IN OUR STOCK, AND THE 6 INDIVIDUAL UNOPENED SETS AND SENT THEM TO CENTRAL SUPPLY TO ADD TO THE OTHER CASES TO BE SENT BACK. [REDACTED] FROM CENTRAL SUPPLY SAID SHE WOULD REACH OUT TO THE SUPPLIER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2797785 MEDICAL IMAGING SOLUTIONS INTL. INJECTOR AND SYRINGE, ANGIOGRAPHIC DXT CANADIAN HOSPITAL SPECIALTIES LTD 400109 2503333, 2503336, 2503339

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown