BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STELLANT DUAL CT INJECTOR

    MDR report key: 17986637 · Received October 23, 2023

    Report

    Report Number
    2520313-2023-00026
    Event Type
    Injury
    Date Received
    October 23, 2023
    Date of Event
    September 25, 2023
    Report Date
    September 23, 2024
    Manufacturer
    BAYER MEDICAL CARE INC.
    Product Code
    DXT
    UDI-DI
    00616258020860
    PMA / PMN Number
    K082905
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A SYSTEM SERVICE CHECK OF THE MEDRAD® STELLANT CT INJECTION SYSTEM, SERIAL NUMBER (B)(6), WAS DECLINED BY THE CUSTOMER. THE CUSTOMER DISCARDED THE SUSPECT DISPOSABLES AT THE TIME OF THE INCIDENT; HOWEVER, THEY WERE ABLE TO PROVIDE A LOT NUMBER FOR THE DISPOSABLE KIT THAT WAS IN USE. BAYER PRODUCT ANALYSIS TESTED A RETAINED SAMPLE FROM DISPOSABLE SJS-PT-J KIT, LOT NUMBER 8621072. FUNCTIONAL TESTING CONCLUDED THAT THE RETAINED DISPOSABLES PERFORMED TO SPECIFICATION WITH NO PROBLEMS OBSERVED. AN OFFER FOR ADDITIONAL APPLICATIONS TRAINING HAS BEEN MADE AND DECLINED BY THE SITE. 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 WAS NOTIFIED OF AN EXTRAVASATION THAT OCCURRED DURING AN ENHANCED CT SCAN WHILE A PATIENT WAS CONNECTED TO A MEDRAD® STELLANT CT INJECTION SYSTEM (SN (B)(6)). AN ESTIMATED 56 ML OF CONTRAST EXTRAVASATED AT THE INJECTION SITE. A COLD COMPRESS WAS APPLIED TO THE AFFECTED EXTREMITY AND AN ULTRASOUND EXAMINATION WAS PERFORMED THE FOLLOWING DAY WHICH CONFIRMED THAT THE ISSUE HAD RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1856770 STELLANT DUAL CT INJECTOR CT INJECTION SYSTEM DXT BAYER MEDICAL CARE INC. 85937286 00616258020860

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Female Other SJS-PT-J - LOT 8621072