BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAPERGUARD EVAC TRACHEAL 8.5

    MDR report key: 2113409 · Received May 26, 2011

    Report

    Report Number
    2936999-2011-00349
    Event Type
    Injury
    Date Received
    May 26, 2011
    Date of Event
    March 16, 2011
    Report Date
    May 3, 2011
    Manufacturer
    COVIDIEN/ FORMERLY TYCO HEALTHCARE
    Product Code
    BTR
    PMA / PMN Number
    K090352
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CI
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORD FOR THE LOT NUMBER PROVIDED WILL BE REVIEWED. THE TUBE WAS DISCARDED. WITHOUT THE SAMPLE FOR INVESTIGATION, THE FAILURE MODE CANNOT BE CONFIRMED OR A ROOT CAUSE DETERMINED. INFO HAS BEEN ADDED TO THE DATABASE FOR TRENDING PURPOSES.

    Description of Event or Problem · 1

    THE COVIDIEN REP IN CHILE RECEIVED A REPORT FROM A CUSTOMER THAT THE CUFF DEFLATED MINUTES AFTER BEING INFLATED. THE TUBE WAS REMOVED AND THE PT WAS RE-INTUBATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TAPERGUARD EVAC TRACHEAL 8.5 ENDOTRACHEAL TUBE BTR COVIDIEN/ FORMERLY TYCO HEALTHCARE 1005000171

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention