BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MALLINCRODT

    MDR report key: 1935823 · Received December 3, 2010

    Report

    Report Number
    2936999-2010-01351
    Event Type
    Malfunction
    Date Received
    December 3, 2010
    Date of Event
    November 1, 2010
    Report Date
    November 5, 2010
    Manufacturer
    COVIDIEN, FORMERLY TYCO
    Product Code
    BTR
    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 K841872. THE SAMPLE ASSOCIATED TO 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. SEE SCANNED PAGE.

    Description of Event or Problem · 1

    THE COMPANY RECEIVED A REPORT WHERE IT WAS CLAIMED THAT THE CUFF DEVELOPED A LEAK AFTER A SHORT PERIOD DURING PATIENT USE. THE END CLINICIAN ELECTED TO EXTUBATE AND REINTUBATE WITH A REPLACEMENT TUBE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MALLINCRODT REINFORCED TRACHEAL TUBE BTR COVIDIEN, FORMERLY TYCO 2009106127

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention