BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERILE HIGH PRESSURE ANGIOGRAPHIC SYRINGES FOR SINGLE USE

    MDR report key: 24134157 · Received January 21, 2026

    Report

    Report Number
    MW5182586
    Event Type
    Malfunction
    Date Received
    January 21, 2026
    Date of Event
    January 14, 2026
    Report Date
    January 15, 2026
    Manufacturer
    ECOMED SOLUTIONS, LLC
    Product Code
    DXT
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OH, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    PATIENT RECEIVING MRI CONTRAST VIA POWER INJECTION USING STANDARD IV INJECTION KIT. FOLLOWING CONTRAST INJECTION NOTED THAT THE CONTRAST WAS NOT ADMINISTERED AND THE PATIENTS BLOOD FLOWED BACKWARDS THROUGH THE CIRCUIT VIA A SMALL SPLIT AT THE DISTAL END OF THE TUBING PROVIDED WITH THE INJECTOR KIT JUST PROXIMAL TO THE HUB WHICH CONNECTS TO THE PATIENTS IV TUBING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    202970 STERILE HIGH PRESSURE ANGIOGRAPHIC SYRINGES FOR SINGLE USE INJECTOR AND SYRINGE, ANGIOGRAPHIC DXT ECOMED SOLUTIONS, LLC 250528

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Female