BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDRAD® STELLANT FLEX CT INJECTION SYSTEM WITH CENTEGRA WORKSTATION

    MDR report key: 25322577 · Received May 28, 2026

    Report

    Report Number
    2520313-2026-00016
    Event Type
    Injury
    Date Received
    May 28, 2026
    Date of Event
    May 14, 2026
    Report Date
    May 28, 2026
    Manufacturer
    BAYER MEDICAL CARE INC.
    Product Code
    DXT
    UDI-DI
    00616258011219
    PMA / PMN Number
    K192370
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    A SYSTEM SERVICE CHECK OF THE MEDRAD® STELLANT FLEX CT INJECTION SYSTEM (SERIAL NUMBER: (B)(6) WAS COMPLETED ON (B)(6) 2026, BY A BAYER SERVICE REPRESENTATIVE, WHO CONFIRMED THAT THE INJECTOR WAS OPERATING WITHIN SPECIFICATIONS. RETAINED SAMPLES FOR THE POTENTIAL REPORTED LOT NUMBERS HAVE BEEN ORDERED AND ARE UNDERGOING TESTING. THE INVESTIGATION REMAINS IN PROGRESS, AND A FOLLOW-UP REPORT WILL BE PROVIDED UPON COMPLETION. 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 NOTIFIED OF AN ALLEGED AIR EMBOLISM INVOLVING A 55-YEAR-OLD FEMALE PATIENT WITH AN ADMITTING DIAGNOSIS OF PLEURITIC CHEST PAIN WHO UNDERWENT A CTA EXAM USING A MEDRAD® STELLANT FLEX CT INJECTION SYSTEM (SERIAL NUMBER: (B)(6). POST-PROCEDURE, THE RADIOLOGIST NOTED APPROXIMATELY 2 ML OF AIR IN THE PULMONARY TRUNK. NO MEDICAL INTERVENTION WAS REPORTED; HOWEVER, THE PATIENT WAS OBSERVED OVERNIGHT IN THE ICU. THE PATIENT REMAINED STABLE, WITH NO REPORTED COMPLICATIONS. THE CUSTOMER REPORTED NO LEAKAGE OR ABNORMALITIES DURING THE PROCEDURE OR DURING EQUIPMENT CHECKS PERFORMED BEFORE AND AFTER THE PROCEDURE. FOUR POTENTIAL LOT NUMBERS (8683700, 8682451, 8683725, AND 8670115) OF THE MEDRAD® STELLANT FLEX 150 ML STERILE DISPOSABLE SYRINGE KIT (FLEXD-150-SCS) WERE IN USE THAT DAY; HOWEVER, THE SPECIFIC LOT ASSOCIATED WITH THE ALLEGATION COULD NOT BE CONFIRMED. DURING A SUBSEQUENT RETROSPECTIVE EVALUATION OF DISPOSED SYRINGE TUBING, THE CUSTOMER IDENTIFIED ONE MEDRAD® STELLANT FLEX 150 ML STERILE DISPOSABLE SYRINGE KIT (FLEXD-150-SCS, LOT UNKNOWN) IN A WASTE RECEPTACLE WITH PARTIAL SEPARATION AT THE T-CONNECTOR. IT IS NOT CLEAR WHETHER THIS KIT WAS THE ONE IN USE DURING THE SUBJECT INCIDENT. AT THE TIME OF DISCOVERY, APPROXIMATELY ONE-QUARTER OF THE T-CONNECTOR (CONNECTING THE SALINE TUBING WITH THE CONTRAST TUBING) REMAINED INTACT, AND AIR BUBBLES WERE OBSERVED BETWEEN SYRINGES 1 AND 2. UPON FURTHER HANDLING, THE TUBING WAS NOTED TO BE FULLY SEPARATED. THE SUSPECT PRODUCT WAS NOT AVAILABLE FOR RETURN OR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    72530 MEDRAD® STELLANT FLEX CT INJECTION SYSTEM WITH CENTEGRA WORKSTATION CT INJECTION SYSTEM DXT BAYER MEDICAL CARE INC. 85577026 00616258011219

    Patients

    Seq Age Sex Outcome Treatment
    1