BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STELLANT DUAL CT INJECTOR

    MDR report key: 18226883 · Received November 29, 2023

    Report

    Report Number
    2520313-2023-00032
    Event Type
    Injury
    Date Received
    November 29, 2023
    Date of Event
    November 10, 2023
    Report Date
    September 23, 2024
    Manufacturer
    BAYER MEDICAL CARE INC.
    Product Code
    DXT
    UDI-DI
    00616258020792
    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 NOVEMBER 14, 2023 WHICH CONFIRMED THAT THE INJECTOR WAS OPERATING WITHIN BAYER SPECIFICATIONS. MULTIPLE DOCUMENTED ATTEMPTS HAVE BEEN MADE TO GAIN SPECIFIC INFORMATION RELATED TO THE REPORTED EVENT, INCLUDING THE DISPOSABLES INVOLVED; HOWEVER, THESE ATTEMPTS HAVE BEEN UNSUCCESSFUL. IN THE EVENT THAT ADDITIONAL INFORMATION IS OBTAINED, A FOLLOW-UP REPORT WILL BE SUBMITTED. THE MEDRAD® STELLANT FLEX CT INJECTION SYSTEM OPERATION MANUAL CAUTIONS THE USER AS FOLLOWS: WARNING: AIR EMBOLIZATION CAN CAUSE DEATH OR SERIOUS INJURY TO THE PATIENT. DO NOT CONNECT A PATIENT TO THE INJECTOR UNTIL ALL TRAPPED AIR HAS BEEN CLEARED FROM THE SYRINGE AND FLUID PATH. THIS INFORMATION DOES NOT CONSTITUTE AN ADMISSION THAT THE DEVICE, THE COMPANY, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO A REPORTABLE EVENT.

    Additional Manufacturer Narrative · 0

    UDI RELATED DATA QUALITY UPDATES ONLY CORRECTION: FOR UDI DATA DISCREPANCY/MISMATCH ON PREVIOUSLY SUBMITTED MDR AND TO ENSURE THE DEVICE IDENTIFICATION DATA IS IN ALIGNMENT WITH GUDID.

    Description of Event or Problem · 0

    ON NOVEMBER 14, 2023 BAYER MEDICAL CARE INC. RECEIVED INFORMATION THAT A PATIENT WHO WAS UNDERGOING A CT SCAN SUFFERED AN ALLEGED AIR INJECTION WHILE CONNECTED TO A MEDRAD® STELLANT FLEX CT INJECTION SYSTEM (B)(6). THE PATIENT WAS REPORTED TO HAVE REQUIRED MEDICAL TREATMENT FOR THE AIR INJECTION. ALTHOUGH NO ADDITIONAL DETAILS WERE PROVIDED, THE CUSTOMER DID CONFIRM THAT THE PATIENT IS DOING FINE NOW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    98896 STELLANT DUAL CT INJECTOR CT INJECTION SYSTEM DXT BAYER MEDICAL CARE INC. 85631829 00616258020792

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other