BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MALLINCKRODT

    MDR report key: 2141077 · Received June 21, 2011

    Report

    Report Number
    2936999-2011-00434
    Event Type
    Injury
    Date Received
    June 21, 2011
    Date of Event
    May 1, 2011
    Report Date
    May 27, 2011
    Manufacturer
    COVIDIEN, FORMERLY TYCOHEALTHCARE
    Product Code
    BTS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    PART NUMBER# 126-37 IS NOT DISTRIBUTED IN THE U.S.; HOWEVER IS A DEVICE OF ESSENTIALLY IDENTICAL DESIGN DISTRIBUTED IN THE U.S. APPLICABLE 510K# FOR U.S. DISTRIBUTED PART IS K771219. 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 CUFF BURST DURING PT USE. EXTUBATION AND REINTUBATION OF A REPLACEMENT TUBE WAS REQUIRED. THE TUBE WAS REPLACED WITHOUT INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MALLINCKRODT BRONCHO-CATH ENDOBRONCHIAL TUBE BTS COVIDIEN, FORMERLY TYCOHEALTHCARE 2010081955

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention