BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MICROCUFF ENDOTRACHEAL TUBE

    MDR report key: 20226313 · Received September 13, 2024

    Report

    Report Number
    MW5159590
    Event Type
    Injury
    Date Received
    September 13, 2024
    Date of Event
    July 3, 2024
    Report Date
    September 11, 2024
    Manufacturer
    AVANOS MEDICAL INC. (FORMERLY HALYARD HEALTH INC.)
    Product Code
    BTR
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    PATIENT REQUIRED EMERGENT INTUBATION, 4 TUBES WERE UTILIZED IN ATTEMPT TO INTUBATE. ALL TUBES WERE REPLACED DUE TO CUFF LEAKING AIR. PATIENT TO OPERATING ROOM FOR TRACHEOSTOMY. ETT 7.5, LOT # CM3227003; ETT 7.5, LOT # CM 3172002; ETT 8.0, LOT#3244002; ETT 8.0, LOT#3118001. REFERENCE REPORTS: MW5159591, MW5159592 AND MW5159593.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1816389 MICROCUFF ENDOTRACHEAL TUBE TUBE, TRACHEAL (W/WO CONNECTOR) BTR AVANOS MEDICAL INC. (FORMERLY HALYARD HEALTH INC.) CM3227003

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Life Threatening