BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDRAD® CENTARGO CT INJECTOR

    MDR report key: 24943304 · Received April 21, 2026

    Report

    Report Number
    2520313-2026-00013
    Event Type
    Injury
    Date Received
    April 21, 2026
    Date of Event
    February 25, 2026
    Report Date
    May 20, 2026
    Manufacturer
    IMAXEON PTY LTD
    Product Code
    DXT
    UDI-DI
    09345390002915
    PMA / PMN Number
    K241849
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE MEDRAD® CENTARGO DAY SET AND PATIENT LINE DISPOSABLE SETS THAT WERE IN USE DURING THE PROCEDURE WERE DISCARDED BY THE SITE; THEREFORE, THEY ARE NOT AVAILABLE FOR EVALUATION. THE CUSTOMER WAS UNABLE TO PROVIDE THE LOT NUMBERS OF THE DISPOSABLES; THEREFORE, TESTING OF RETAINED SAMPLES WAS NOT POSSIBLE. ADDITIONAL APPLICATIONS TRAINING WAS OFFERED; HOWEVER, THE CUSTOMER DECLINED. A SYSTEM SERVICE CHECK OF THE MEDRAD® CENTARGO CT INJECTION SYSTEM (SN (B)(6) HAS BEEN REQUESTED AND WE ARE AWAITING THE RESULTS. 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 RECEIVED A REPORT OF AN ALLEGED AIR INJECTION DURING USE OF A MEDRAD® CENTARGO CT INJECTION SYSTEM (SN (B)(6). A 44-YEAR-OLD MALE PATIENT WAS UNDERGOING A CONTRAST ENHANCED ABDOMEN AND PELVIS CT EXAMINATION TO RULE OUT HEPATIC INJURY STATUS POST MOTOR VEHICLE CRASH (MVC). APPROXIMATELY LESS THAN 10ML OF AIR WAS REPORTEDLY VISUALIZED IN THE RIGHT VENTRICLE OF THE HEART ON THE DISPLAYED IMAGES. THE PATIENT WAS SUBSEQUENTLY ADMITTED TO THE HOSPITAL AND NO FURTHER INFORMATION REGARDING THEIR STATUS WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    481406 MEDRAD® CENTARGO CT INJECTOR CT INJECTION SYSTEM DXT IMAXEON PTY LTD 88982797 09345390002915

    Patients

    Seq Age Sex Outcome Treatment
    1