BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STELLANT DUAL CT INJECTOR

    MDR report key: 18779380 · Received February 26, 2024

    Report

    Report Number
    2520313-2024-00003
    Event Type
    Injury
    Date Received
    February 26, 2024
    Date of Event
    February 1, 2024
    Report Date
    September 25, 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
    GM
    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 PERFORMED (B)(6) 2024 WHICH CONFIRMED THAT THE INJECTOR WAS OPERATING WITHIN BAYER SPECIFICATIONS. THE OFFER OF ADDITIONAL APPLICATIONS TRAINING WAS ACCEPTED AND PROVIDED BY THE BAYER CLINICAL PERFORMANCE TEAM. BAYER PRODUCT ANALYSIS TESTED THE MEDRAD® STELLANT STERILE DISPOSABLE SYRINGE KIT (SDS-TRF-CV), LOT NUMBER 8636608, IN USE DURING THE PROCEDURE AND CONCLUDED THAT IT PERFORMED TO SPECIFICATION WITH NO PROBLEMS OBSERVED. THE MEDRAD® STELLANT 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.

    Additional Manufacturer Narrative · 0

    A SYSTEM SERVICE CHECK OF THE MEDRAD® STELLANT CT INJECTION SYSTEM (SERIAL NUMBER(B)(6) WAS PERFORMED (B)(6) 2024 WHICH CONFIRMED THAT THE INJECTOR WAS OPERATING WITHIN BAYER SPECIFICATIONS. THE MEDRAD® STELLANT STERILE DISPOSABLE SYRINGE KIT (SDS-TRF-CV), LOT NUMBER 8636608, IN USE DURING THE PROCEDURE IS BEING RETURNED FOR A FULL EVALUATION. 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 INC. WAS INFORMED THAT A 74-YEAR-OLD FEMALE SUFFERED AN ALLEGED AIR INJECTION WHILE CONNECTED TO A MEDRAD® STELLANT CT INJECTION SYSTEM (SN (B)(6)). THE CUSTOMER REPORTED THAT A PHYSICIAN OBSERVED APPROXIMATELY 10 ML OF FREE AIR ON THE DISPLAYED IMAGES. AFTER AN UNDISCLOSED PERIOD, THE PATIENT WAS SENT FOR A FOLLOW-UP CT SCAN. THE CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN.

    Description of Event or Problem · 0

    BAYER MEDICAL CARE INC. WAS INFORMED THAT A 74-YEAR-OLD FEMALE SUFFERED AN ALLEGED AIR INJECTION WHILE CONNECTED TO A MEDRAD® STELLANT CT INJECTION SYSTEM (SN (B)(6). THE CUSTOMER REPORTED THAT A PHYSICIAN OBSERVED APPROXIMATELY 10 ML OF FREE AIR ON THE DISPLAYED IMAGES. AFTER AN UNDISCLOSED PERIOD, THE PATIENT WAS SENT FOR A FOLLOW-UP CT SCAN. THE CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    297606 STELLANT DUAL CT INJECTOR CT INJECTION SYSTEM DXT BAYER MEDICAL CARE INC. 85937286 00616258020860

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Female Other SDS-TRF-CV - LOT: 8636608.| SDS-TRF-CV - LOT: 8636608.