BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAPERGUARD EVAC

    MDR report key: 2210371 · Received August 8, 2011

    Report

    Report Number
    2936999-2011-00484
    Event Type
    Injury
    Date Received
    August 8, 2011
    Date of Event
    July 1, 2011
    Report Date
    July 14, 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
    MO, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOT NUMBER IS UNKNOWN THEREFORE THE DATE OF MANUFACTURE CAN NOT BE DETERMINED. THIS REPORT IS REGARDING THE SECOND OF (2) TUBES AS REFERENCED IN REPORT 2936999-2011-00483.

    Description of Event or Problem · 1

    THE CALLER REPORTED THAT 2 TAPERGUARD EVAC TUBES HAD POPPED UP AND OUT OF THE PATIENT'S TRACHEA IN THE LAST TWO WEEKS. SHE STATED IT WAS REPORTED TO HER THAT IN THE SECOND INCIDENT THE PATIENT WAS RE-INTUBATED USING A SCOPE AND THE NEW TUBE IS STILL BELIEVED TO BE IN THE PATIENT. THE PATIENT WAS ON A "MACQUET" VENTILATOR ON HIGH PRESSURE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention