BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BUNNELL LIFEPORT 2.5MM ENDOTRACHEAL TUBE ADAPTER

    MDR report key: 18526947 · Received January 16, 2024

    Report

    Report Number
    MW5150407
    Event Type
    Injury
    Date Received
    January 16, 2024
    Date of Event
    January 4, 2024
    Report Date
    January 11, 2024
    Manufacturer
    BUNNELL, INC.
    Product Code
    LSZ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    PATIENT ON A HIGH FREQUENCY JET VENTILATOR WITH ENDOTRACHEAL TUBE ADAPTER CONTINUOUSLY POPPING OFF FROM SITE CAUSING OPENING OF SYSTEM. PATIENT REQUIRED REINTUBATION AND NEW TUBING SYSTEM. ON (B)(6) 2024, PATIENT NOW POSITIVE FOR KLEBSIELLA OXYTOCA, COLLECTED FROM ENDOTRACHEAL ASPIRATION. PRE-TERM NEWBORN 22.2 WEEKS, ON HIGH FLOW JET VENTILATOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    554513 BUNNELL LIFEPORT 2.5MM ENDOTRACHEAL TUBE ADAPTER VENTILATOR, HIGH FREQUENCY LSZ BUNNELL, INC. 23043166

    Patients

    Seq Age Sex Outcome Treatment
    1 1 MO Male Other