BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDRAD® STELLANT CT INJECTION SYSTEM WITH CENTEGRA WORKSTATION

    MDR report key: 25111006 · Received May 7, 2026

    Report

    Report Number
    2520313-2026-00015
    Event Type
    Injury
    Date Received
    May 7, 2026
    Date of Event
    April 25, 2026
    Report Date
    May 26, 2026
    Manufacturer
    BAYER MEDICAL CARE INC.
    Product Code
    DXT
    UDI-DI
    00616258020860
    PMA / PMN Number
    K082905
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS INVESTIGATION REMAINS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A FOLLOW-UP REPORT WILL BE SUBMITTED. THIS INFORMATION DOES NOT CONSTITUTE AN ADMISSION THAT THE DEVICE, THE COMPANY, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO A REPORTABLE EVENT.

    Description of Event or Problem · 0

    BAYER MEDICAL CARE INC. WAS INFORMED OF AN ALLEGED AIR INJECTION INVOLVING A FEMALE PATIENT THAT OCCURRED ON (B)(6) 2026, DURING A CT EXAMINATION OF THE HEAD AND CHEST WHILE CONNECTED TO A MEDRAD® STELLANT CT INJECTION SYSTEM (SERIAL NUMBER 303460). ACCORDING TO THE INFORMATION PROVIDED, AIR BUBBLES WERE OBSERVED ON IMAGING WITHIN THE JUGULAR VEIN, ENCEPHALIC VEIN, AND SUPERIOR VENA CAVA. AS A PRECAUTIONARY MEASURE, THE PATIENT'S LEGS WERE ELEVATED AND THE OXYGEN CONCENTRATION WAS INCREASED FROM 25% TO 50%, AS DIRECTED BY THE ANESTHETIST. NO ADVERSE HEALTH CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    144802 MEDRAD® STELLANT CT INJECTION SYSTEM WITH CENTEGRA WORKSTATION CT INJECTION SYSTEM DXT BAYER MEDICAL CARE INC. 85937286 00616258020860

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Female Required Intervention| O SDS-CTP-SPK LOT 8671657, SSS-SPD-250 LOT 251517