BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STELLANT DUAL CT INJECTOR

    MDR report key: 23390406 · Received October 27, 2025

    Report

    Report Number
    2520313-2025-00026
    Event Type
    Injury
    Date Received
    October 27, 2025
    Date of Event
    September 30, 2025
    Report Date
    October 27, 2025
    Manufacturer
    BAYER MEDICAL CARE INC.
    Product Code
    DXT
    UDI-DI
    00616258011219
    PMA / PMN Number
    K192370
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A SYSTEM SERVICE CHECK OF THE STELLANT FLEX CT INJECTOR, SERIAL NUMBER (B)(6), WAS COMPLETED ON (B)(6) 2025, WHICH CONFIRMED THAT THE INJECTOR WAS OPERATING WITHIN BAYER SPECIFICATIONS. THE MEDRAD® STELLANT FLEX DISPOSABLES THAT WERE IN USE DURING THE PROCEDURE WERE DISCARDED BY THE CUSTOMER; 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 CUSTOMER DECLINED THE OFFER OF ADDITIONAL CLINICAL APPLICATIONS TRAINING. THE MEDRAD® STELLANT FLEX 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

    BAYER MEDICAL CARE WAS NOTIFIED OF AN ALLEGED AIR INJECTION THAT HAD OCCURRED DURING A CT SCAN WHILE THE PATIENT WAS CONNECTED TO A MEDRAD® STELLANT FLEX CT INJECTION SYSTEM (SERIAL NUMBER (B)(6)). FOLLOWING THE INJECTION, AN UNDISCLOSED AMOUNT OF AIR WAS VISUALIZED ON THE DISPLAYED IMAGES. THE PATIENT WAS PLACED IN LEFT LATERAL DECUBITUS POSITION, ADMINISTERED SUPPLEMENTAL OXYGEN AT 15L, AND ADMITTED TO THE INTENSIVE CARE UNIT FOR TELEMETRY AND MONITORING. THE PATIENT IS REPORTED TO BE IN STABLE CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2798791 STELLANT DUAL CT INJECTOR CT INJECTION SYSTEM DXT BAYER MEDICAL CARE INC. 85577026 00616258011219

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR Male Other