BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MALLINCKRODT

    MDR report key: 1970407 · Received January 19, 2011

    Report

    Report Number
    2936999-2011-00054
    Event Type
    Injury
    Date Received
    January 19, 2011
    Date of Event
    December 1, 2010
    Report Date
    December 21, 2010
    Manufacturer
    COVIDIEN, FORMERLY TYCO HEALTHCARE
    Product Code
    BTR
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    PART NUMBER# 100-80-1 IS NOT DISTRIBUTED IN THE U.S.; HOWEVER IS A DEVICE OF ESSENTIALLY IDENTICAL DESIGN DISTRIBUTED IN THE U.S. APPLICABLE 510K# FOR U.S. DISTRIBUTED PART IS K871204. THE SAMPLE ASSOCIATED TO THIS REPORT IS CURRENTLY IN TRANSIT TO THE MANUFACTURING SITE FOR ANALYSIS. IF SIGNIFICANT INFO IS IDENTIFIED FROM THE INVESTIGATION, A SUMMARY OF THE INVESTIGATION RESULTS WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 1

    PART NUMBER# 100-80-1 IS NOT DISTRIBUTED IN THE U.S.; HOWEVER IS A DEVICE OF ESSENTIALLY IDENTICAL DESIGN DISTRIBUTED IN THE U.S. APPLICABLE 510K# FOR U.S. DISTRIBUTED PART IS K871204. THE SAMPLE ASSOCIATED TO THIS REPORT IS CURRENTLY IN TRANSIT TO THE MANUFACTURING SITE FOR ANALYSIS. IF SIGNIFICANT INFO IS IDENTIFIED FROM THE INVESTIGATION, A SUMMARY OF THE INVESTIGATION RESULTS WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    THE COMPANY RECEIVED A REPORT WHERE IT WAS CLAIMED THAT THE TUBE FOLLOWING ONE WEEK OF PT USE THE END CLINICIANS HEARD A INTERMITTENT LEAK BUT COULD NOT IDENTIFY THE SOURCE OF THE LEAK. THE END CLINICIAN ELECTED TO INSPECT THE TUBE AND DURING THE TUBE SEPARATED FROM THE 15MM CONNECTOR. THE END CLINICIAN EXTUBATED AND REINTUBATED WITH A REPLACEMENT TUBE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MALLINCKRODT HI-LO TRACHEAL TUBE BTR COVIDIEN, FORMERLY TYCO HEALTHCARE 2010038596

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Required Intervention