BEUDAMED
    FDA Adverse Event Death Summary report: N

    PARKER FLEX TIP ET TUBE 8 FRENCH

    MDR report key: 21312809 · Received February 5, 2025

    Report

    Report Number
    MW5165649
    Event Type
    Death
    Date Received
    February 5, 2025
    Date of Event
    January 20, 2025
    Report Date
    February 2, 2025
    Manufacturer
    WELL LEAD MEDICAL CO. LTD.
    Product Code
    BTR
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NE, US
    Reporter Occupation
    501
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    PATIENT WAS SAT UP IN BED FOR A CHEST X-RAY. ET TUBE HAD BEEN IN PLACE SINCE (B)(6) 2025. SUDDEN CHANGE IN OXYGENATION AND VENTILATION NOTED. OBVIOUS CUFF LEAK. RN AND RT INJECTED 3 CC OF AIR WITH IMPROVEMENT AND THEN RAPID SOFTENING OF THE PILOT BALLOON. RECURRENCE OF OBVIOUS CUFF LEAK. UNABLE TO MAINTAIN CUFF PRESSURE. TUBE EMERGENTLY REPLACED. AFTER REINTUBATION, CARDIAC DYSFUNCTION WITH LOSS OF PULSE. CODE CALLED. PILOT LINE WAS CUT DURING EXTUBATION AND REINTUBATION. POST PROCEDURE EXAMINATION OF THE BALLOON SHOWED BALLOON PARTIALLY INFLATED. UTILIZING NEEDLE AND SYRINGE STAFF UNABLE TO INFLATE CUFF. PRESSURE TO CUFF ON THE OUTSIDE OF THE CUFF DOES NOT CREATE A LEAK. UNABLE TO TEST PILOT LINE OR INJECTION PORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1159159 PARKER FLEX TIP ET TUBE 8 FRENCH TUBE, TRACHEAL (W/WO CONNECTOR) BTR WELL LEAD MEDICAL CO. LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Male Death