BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MALLINCKRODT

    MDR report key: 1935977 · Received December 9, 2010

    Report

    Report Number
    2936999-2010-01361
    Event Type
    Injury
    Date Received
    December 9, 2010
    Date of Event
    October 1, 2010
    Report Date
    November 11, 2010
    Manufacturer
    COVIDIEN, FORMERLY TYCOHEALTH
    Product Code
    BTR
    PMA / PMN Number
    K791045
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    PART NUMBER# 317-80 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 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 REC'D A REPORT WHERE IT WAS CLAIMED THAT THE TUBE DEVELOPED CUFF LEAK DURING PT USE. THE END CLINICIAN ELECTED TO EXTUBATE AND REINTUBATE THE PT WITH A REPLACEMENT TUBE. THE TUBE WAS REPLACED WITHOUT INCIDENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention