BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STELLANT DUAL CT INJECTOR

    MDR report key: 19003780 · Received March 29, 2024

    Report

    Report Number
    2520313-2024-00006
    Event Type
    Injury
    Date Received
    March 29, 2024
    Date of Event
    February 29, 2024
    Report Date
    September 25, 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 MEDRAD® STELLANT FLEX INJECTION SYSTEM, SERIAL NUMBER (B)(6), WAS PERFORMED ON (B)(6) 2024 WHICH CONFIRMED THAT THE INJECTOR WAS OPERATING WITHIN BAYER SPECIFICATIONS. THE DISPOSABLES IN USE DURING THE INCIDENT WERE NOT SAVED AND LOT NUMBER INFORMATION ON THE DISPOSABLES INVOLVED IN THE EVENT WAS NOT PROVIDED. THE OFFER OF CLINICAL APPLICATIONS TRAINING WAS ACCEPTED BY THE CUSTOMER AND WAS PROVIDED BY THE BAYER CLINICAL PERFORMANCE CENTER ON MARCH 7, 2024. 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

    BAYER MEDICAL CARE INC. WAS INFORMED THAT A 30-YEAR-OLD MALE UNDERGOING A CT SCAN OF THE CHEST, ABDOMEN, AND PELVIS SUFFERED AN ALLEGED AIR INJECTION WHILE CONNECTED TO A MEDRAD® STELLANT FLEX INJECTION SYSTEM (SN (B)(6)). THE CUSTOMER REPORTED THAT THE RADIOLOGIST NOTICED LESS THAN 3 ML OF AIR ON THE DISPLAYED IMAGES. FOLLOWING COMPLETION OF THE PROCEDURE, THE RADIOLOGIST REQUESTED THAT THE PATIENT BE SENT TO THE EMERGENCY DEPARTMENT TO BE MONITORED. THE EMERGENCY DEPARTMENT ADMITTED THE PATIENT TO THE HOSPITAL OVERNIGHT, FOR OBSERVATION. THE PATIENT WAS REPORTED AS STABLE AND WAS DISCHARGED HOME THE FOLLOWING DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2584600 STELLANT DUAL CT INJECTOR CT INJECTION SYSTEM DXT BAYER MEDICAL CARE INC. 85631829 00616258020792

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Male Other