BEUDAMED
    FDA Adverse Event Death Summary report: N

    ARROW CVC SET: 4-LUMEN 8.5FR X 16CM

    MDR report key: 22411076 · Received July 7, 2025

    Report

    Report Number
    3006425876-2025-00580
    Event Type
    Death
    Date Received
    July 7, 2025
    Date of Event
    June 9, 2025
    Report Date
    June 9, 2025
    Manufacturer
    ARROW INTERNATIONAL LLC
    Product Code
    DQY
    UDI-DI
    10801902029239
    PMA / PMN Number
    K862056
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PO
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4)

    Additional Manufacturer Narrative · 0

    QN#(B)(4). COMPLAINT VERIFICATION TESTING COULD NOT BE PERFORMED AS IT WAS REPORTED THAT THE SAMPLE IS NOT AVAILABLE FOR RETURN. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED AND NO RELEVANT FINDINGS WERE IDENTIFIED. WITHOUT THE DEVICE TO EVALUATE THE COMPLAINT COULD NOT BE CONFIRMED AND THE PROBABLE CAUSE COULD NOT BE DETERMINED FROM THE AVAILABLE INFORMATION. TELEFLEX WILL CONTINUE TO MONITOR AND TREND FOR REPORTS OF THIS NATURE.

    Description of Event or Problem · 0

    IT WAS REPORTED "AFTER REMOVAL OF THE CENTRAL VENOUS CATHETER (CVC) PLACED IN THE RIGHT SUBCLAVIAN VEIN, THE PATIENT BEGAN TO SHOW CHANGES IN CONSCIOUSNESS AND MYOCLONUS - PROBABLY GAS EMBOLISM. TREATMENT: HYPERBARIC CHAMBER TREATMENT, + VENTILATION INVASIVE MECHANICS + VASOPRESSOR. " THE PATIENT'S CURRENT CONDITION IS REPORTED AS "DECEASED". ADDITIONAL INFORMATION REPORTS "ROOT CAUSE ANALYSIS WAS CARRIED OUT ON THIS INCIDENT AND THERE WAS NO EVIDENCE OF PROBLEMS WITH THE DEVICE USED, HOWEVER, THE DISTRIBUTOR WAS MADE AWARE OF THE OCCURENCE."

    Description of Event or Problem · 0

    IT WAS REPORTED "AFTER REMOVAL OF THE CENTRAL VENOUS CATHETER (CVC) PLACED IN THE RIGHT SUBCLAVIAN VEIN, THE PATIENT BEGAN TO SHOW CHANGES IN CONSCIOUSNESS AND MYOCLONUS - PROBABLY GAS EMBOLISM. TREATMENT: HYPERBARIC CHAMBER TREATMENT, + VENTILATION INVASIVE MECHANICS + VASOPRESSOR. " THE PATIENT'S CURRENT CONDITION IS REPORTED AS "DECEASED". ADDITIONAL INFORMATION REPORTS "ROOT CAUSE ANALYSIS WAS CARRIED OUT ON THIS INCIDENT AND THERE WAS NO EVIDENCE OF PROBLEMS WITH THE DEVICE USED, HOWEVER, THE DISTRIBUTOR WAS MADE AWARE OF THE OCCURENCE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    897755 ARROW CVC SET: 4-LUMEN 8.5FR X 16CM CATHETER, PERCUTANEOUS DQY ARROW INTERNATIONAL LLC IPN918726 71F24D1491 10801902029239

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death NOT REPORTED| NOT REPORTED