BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MALLINCKRODT

    MDR report key: 1906991 · Received November 9, 2010

    Report

    Report Number
    2936999-2010-01309
    Event Type
    Injury
    Date Received
    November 9, 2010
    Date of Event
    October 1, 2010
    Report Date
    October 10, 2010
    Manufacturer
    COVIDIEN, FORMERLY TYCOHEALTHCARE
    Product Code
    BTO
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    PART NUMBER# 136-90 IS NOT DISTRIBUTED IN THE US; HOWEVER, IS A DEVICE OF ESSENTIALLY IDENTICAL DESIGN DISTRIBUTED IN THE US. APPLICABLE 510K# FOR US DISTRIBUTED PART IS K791045. 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 CUFF BURST DURING PT USE. THE END CLINICIAN ELECTED TO EXTUBATE AND REINTUBATE THE PT WITH A REPLACEMENT TUBE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MALLINCKRODT HI-LO TRACHEAL TUBE WITH LANZ BTO COVIDIEN, FORMERLY TYCOHEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention