BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MALLINCKRODT

    MDR report key: 1821486 · Received August 25, 2010

    Report

    Report Number
    2936999-2010-01140
    Event Type
    Injury
    Date Received
    August 25, 2010
    Date of Event
    July 22, 2010
    Report Date
    July 30, 2010
    Manufacturer
    COVIDIEN, FORMERLY TYCO HEATLHCARE
    Product Code
    BTR
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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.

    Description of Event or Problem · 1

    THE COMPANY RECEIVED A REPORT WHERE IT WAS CLAIMED THAT THE TUBE DEVELOPED A CUFF LEAK AFTER THREE DAYS OF PT USE. EXTUBATION AND REINTUBATION OF A REPLACEMENT TUBE WAS REQUIRED. THIS REPORT IS ASSOCIATED TO THE SECOND OCCURRENCE REPORTED ON MFR #293699-2010-01139/RX201008-0050.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MALLINCKRODT REINFORCED TRACHEAL TUBE BTR COVIDIEN, FORMERLY TYCO HEATLHCARE 2010047328

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention