BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNSPECIFIED ENDOTRACH TUBE

    MDR report key: 10511260 · Received September 9, 2020

    Report

    Report Number
    2936999-2020-00659
    Event Type
    Injury
    Date Received
    September 9, 2020
    Date of Event
    June 23, 2020
    Report Date
    September 9, 2020
    Manufacturer
    COVIDIEN LP JUAREZ (MMJ)
    Product Code
    BTR
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER, DURING USE, THE PATIENT WAS LOSING TIDAL VOLUME THAT RANGED BETWEEN 140-200 ML, AND A 14 ML OF AIR WAS INTRODUCED IN THE PILOT BALLOON BUT THE CUFF WOULD STILL NOT INFLATE. THE PATIENT HAD AN EMERGENCY REPLACEMENT OF THE TUBE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    971658 UNSPECIFIED ENDOTRACH TUBE TUBE, TRACHEAL (W/WO CONNECTOR) BTR COVIDIEN LP JUAREZ (MMJ) UNSPECIFIED ENDOTRACH TUBE

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention