BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MALLINCKRODT

    MDR report key: 1970140 · Received January 13, 2011

    Report

    Report Number
    2936999-2011-00030
    Event Type
    Injury
    Date Received
    January 13, 2011
    Date of Event
    December 1, 2010
    Report Date
    December 17, 2010
    Manufacturer
    COVIDIEN, FORMERLY TYCO HEALTHCARE
    Product Code
    BTR
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NO
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    PART NUMBER # 107-70 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 K965132. 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 MALFORMED DURING PATIENT USE RESULTING A SATURATION LOSS. EXTUBATION OF THE TUBE WAS REQUIRED. REINTUBATION OF A REPLACEMENT TUBE WAS PERFORMED AND THE TUBE WAS REPLACED WITHOUT INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MALLINCKRODT INTERMEDIATE HI-LO TRACHEAL TUBE BTR COVIDIEN, FORMERLY TYCO HEALTHCARE 2010038178

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention