BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MALLINCKRODT

    MDR report key: 2003665 · Received February 23, 2011

    Report

    Report Number
    2936999-2011-00138
    Event Type
    Injury
    Date Received
    February 23, 2011
    Date of Event
    January 1, 2011
    Report Date
    January 25, 2011
    Manufacturer
    COVIDIEN, FORMERLY TYCOHEALTHCARE
    Product Code
    BTR
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    PART NUMBER # 118-60 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 K841872. THE SAMPLE ASSOCIATED WITH THIS REPORT IS CURRENTLY IN TRANSIT TO THE MANUFACTURING SITE FOR ANALYSIS. IF SIGNIFICANT INFORMATION 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 CLAIMED THAT THE CUFF DEVELOPED A TEAR DURING PATIENT USE. THE END CLINICIAN ELECTED TO EXTUBATE AND REINTUBATE WITH A REPLACEMENT TUBE. THE TUBE WAS REPLACED WITHOUT INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MALLINCKRODT REINFORCED TRACHEAL TUBE BTR COVIDIEN, FORMERLY TYCOHEALTHCARE 2010070939

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention