BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTRACHEAL TUBE

    MDR report key: 10343827 · Received July 29, 2020

    Report

    Report Number
    MW5095801
    Event Type
    Injury
    Date Received
    July 29, 2020
    Date of Event
    June 23, 2020
    Report Date
    July 27, 2020
    Manufacturer
    COVIDIEN
    Product Code
    BTR
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    501

    Narratives

    Description of Event or Problem · 1

    INCIDENT OCCURRED ON (B)(6) 2020 AT 0150. PER PATIENT CHART AND RL DATIX, PATIENT IS LOSING TIDAL VOLUME ¿ VOLUME RANGE BETWEEN 140-200 ML, RT INTRODUCE ABOUT 14ML OF AIR IN THE PILOT BALLOON AND STILL UNABLE TO INFLATE THE CUFF. EMERGENCY RE- INTUBATION WAS PERFORMED. EQUIPMENT SAVED FOR REVIEW AND SENT BACK TO MANUFACTURER FOR REVIEW. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    805944 ENDOTRACHEAL TUBE TUBE, TRACHEAL (W/WO CONNECTOR) BTR COVIDIEN

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Life Threatening| R