BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COVIDIEN

    MDR report key: 13111199 · Received December 28, 2021

    Report

    Report Number
    MW5106321
    Event Type
    Injury
    Date Received
    December 28, 2021
    Date of Event
    November 24, 2021
    Report Date
    December 23, 2021
    Manufacturer
    COVIDIEN
    Product Code
    BTR
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CO, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    ENDOTRACHEAL TUBE FOUND TO HAVE LEAK IN THE BALLOON. ETT EXCHANGED. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2000122 COVIDIEN TUBE, TRACHEAL (W/WO CONNECTOR) BTR COVIDIEN 86450

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Female Other| R