BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MALLINCKRODT

    MDR report key: 1895381 · Received November 3, 2010

    Report

    Report Number
    2936999-2010-01303
    Event Type
    Injury
    Date Received
    November 3, 2010
    Date of Event
    June 30, 2010
    Report Date
    October 5, 2010
    Manufacturer
    COVIDIEN, FORMERLY TYCOHEALTHCARE
    Product Code
    BTR
    PMA / PMN Number
    K841872
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    PART NUMBER # (B)(4) IS NOT DISTRIBUTED IN THE US; HOWEVER, THERE IS A DEVICE OF ESSENTIALLY IDENTICAL DESIGN DISTRIBUTED IN THE UNITED STATES. APPLICABLE 510K# FOR UNITED STATES DISTRIBUTED PART IS K841872. THE SAMPLE ASSOCIATED TO THIS REPORT IS CURRENTLY IN TRANSIT TO THE MFG 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 TUBE HERNIATED IN A OVAL SHAPE DURING PT USE. THE CALLER REPORTED THAT THIS REPORTED DEFICIENCY RESULTED IN SHORT TERM DESATURATION AND BRACHYCARDIA TO THE PT. THE END CLINICIAN ELECTED TO EXTUBATE THE PT AND REINTUBATE WITH A REPLACEMENT TUBE. THE TUBE WAS REPLACED WITHOUT FURTHER INCIDENT TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MALLINCKRODT REINFORCED TRACHEAL TUBE BTR COVIDIEN, FORMERLY TYCOHEALTHCARE 2006053663

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention