BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STELLANT DUAL CT INJECTOR

    MDR report key: 23827951 · Received December 17, 2025

    Report

    Report Number
    2520313-2025-00032
    Event Type
    Injury
    Date Received
    December 17, 2025
    Date of Event
    November 10, 2025
    Report Date
    December 17, 2025
    Manufacturer
    BAYER MEDICAL CARE INC.
    Product Code
    DXT
    UDI-DI
    00616258020860
    PMA / PMN Number
    K082905
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A SYSTEM SERVICE CHECK OF THE MEDRAD® STELLANT CT INJECTOR (SERIAL NUMBER (B)(6)) WAS COMPLETED ON NOVEMBER 10, 2025 WHICH CONFIRMED THAT THE EQUIPMENT WAS PERFORMING TO BAYER SPECIFICATION. THE STELLANT DISPOSABLE SET THAT WAS IN USE DURING THE PROCEDURE WAS DISCARDED BY THE SITE; THEREFORE, THEY ARE NOT AVAILABLE FOR EVALUATION. THE CUSTOMER WAS UNABLE TO PROVIDE THE LOT NUMBER OF THE DISPOSABLES; THEREFORE, TESTING OF RETAINED SAMPLES WAS NOT POSSIBLE. THE OFFER OF ADDITIONAL CLINICAL APPLICATIONS TRAINING HAS BEEN ACCEPTED BY THE CUSTOMER AND WILL BE SCHEDULED. THE MEDRAD® STELLANT CT INJECTION SYSTEM OPERATION MANUAL CAUTIONS THE USER AS FOLLOWS: WARNING: AIR EMBOLISM HAZARD - SERIOUS PATIENT INJURY OR DEATH MAY RESULT. ENSURE PATIENT IS NOT CONNECTED WHILE PURGING AIR FROM SYRINGE OR ENGAGING OR ADVANCING PLUNGER. EXPEL ALL TRAPPED AIR FROM THE SYRINGE(S), CONNECTORS, TUBING, AND CATHETER BEFORE CONNECTING THE SYSTEM TO THE PATIENT. TO MINIMIZE AIR EMBOLIZATION RISKS, ENSURE THAT ONE OPERATOR IS DESIGNATED THE RESPONSIBILITY OF FILLING THE SYRINGE(S). DO NOT CHANGE OPERATORS DURING THE PROCEDURE. IF AN OPERATOR CHANGE MUST OCCUR, ENSURE THAT THE NEW OPERATOR VERIFIES THAT THE FLUID PATH IS PURGED OF AIR. 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

    THE CUSTOMER REPORTED THE FOLLOWING: (B)(6) YEAR OLD FEMALE PATIENT UNDERGOING A CONTRAST ENHANCED CT SCAN OF THE THORAX WHILE CONNECTED TO A MEDRAD® STELLANT CT INJECTION SYSTEM (SERIAL NUMBER (B)(6)). FOLLOWING THE INJECTION, APPROXIMATELY 9ML OF AIR WAS VISUALIZED WITHIN THE PATIENT'S NECK ON THE DISPLAYED IMAGES. THE PATIENT WAS TRANSFERRED TO THE EMERGENCY DEPARTMENT AND SUBSEQUENTLY UNDERWENT A PERCUTANEOUS INTRAVASCULAR ULTRASOUND GUIDED ASPIRATION OF THE VENOUS AIR. ONCE COMPLETED, THE PATIENT WAS REPORTED TO HAVE BEEN DISCHARGED WITH NO FURTHER ISSUES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2197932 STELLANT DUAL CT INJECTOR CT INJECTION SYSTEM DXT BAYER MEDICAL CARE INC. 85937286 00616258020860

    Patients

    Seq Age Sex Outcome Treatment
    1 90 YR Female Other