BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDICAL IMAGING SOLUTIONS INTL.

    MDR report key: 19728699 · Received July 12, 2024

    Report

    Report Number
    19728699
    Event Type
    Malfunction
    Date Received
    July 12, 2024
    Date of Event
    March 31, 2024
    Report Date
    April 22, 2024
    Manufacturer
    CANADIAN HOSPITAL SPECIALTIES LTD.
    Product Code
    DXT
    UDI-DI
    00850014500344
    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

    MISI CT POWER INJECTOR SYRINGE FOUND TO BE BROKEN UPON OPENING OF PACKAGE. THE "MALE CONNECTION NIPPLE" WHERE THE TUBING ATTACHES WAS BROKEN OFF FROM THE TIP OF THE SYRINGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2346985 MEDICAL IMAGING SOLUTIONS INTL. INJECTOR AND SYRINGE, ANGIOGRAPHIC DXT CANADIAN HOSPITAL SPECIALTIES LTD. 400109 2310242 00850014500344

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown