BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MALLINCKRODT

    MDR report key: 1828177 · Received September 2, 2010

    Report

    Report Number
    2936999-2010-01163
    Event Type
    Injury
    Date Received
    September 2, 2010
    Date of Event
    August 2, 2010
    Report Date
    August 3, 2010
    Manufacturer
    COVIDIEN, FORMERLY TYCOHEALTHCARE
    Product Code
    BTR
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). APPLICABLE 510K# FOR U.S DISTRIBUTED PART IS K965132. 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 DEVELOPED A LEAK CUFF DURING PATIENT 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 HI-LO EVAC TRACHEAL TUBE BTR COVIDIEN, FORMERLY TYCOHEALTHCARE UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention