BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAPERGUARD TRACHEAL TUBE 8.0

    MDR report key: 2201968 · Received August 4, 2011

    Report

    Report Number
    2936999-2011-00491
    Event Type
    Injury
    Date Received
    August 4, 2011
    Date of Event
    May 16, 2011
    Report Date
    July 20, 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
    FR
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOT NUMBER IS UNK THEREFORE, THE DATE OF MFR CAN NOT BE DETERMINED. RETURN OF THE SAMPLE DEVICE FOR MANUFACTURER'S INVESTIGATION WAS REQUESTED, HOWEVER, THE SAMPLE HAS NOT BEEN RETURNED. IF THE SAMPLE IS RETURNED AN INVESTIGATION WILL BE PERFORMED. IF SIGNIFICANT INFO IS IDENTIFIED FROM THE INVESTIGATION, A SUMMARY OF THE FINDINGS WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE VOLUME EXHALED WAS INFERIOR TO INHALED VOLUME. THE TUBE WAS REMOVED AND THE PT WAS RE-INTUBATED. UPON EXAMINATION THE CUFF WAS NOTED TO BE UNEVENLY INFLATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TAPERGUARD TRACHEAL TUBE 8.0 ENDOTRACHEAL TUBE BTR COVIDIEN/FORMERLY TYCO HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention