BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MALLINCKRODT

    MDR report key: 3022904 · Received March 20, 2013

    Report

    Report Number
    2936999-2013-00201
    Event Type
    Malfunction
    Date Received
    March 20, 2013
    Date of Event
    February 11, 2013
    Report Date
    February 22, 2013
    Manufacturer
    COVIDIEN/ FORMERLY TYCO
    Product Code
    BTS
    PMA / PMN Number
    K771219
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLE IN TRANSIT TO THE MFG SITE FOR ANALYSIS.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE BRONCHIAL CUFF MALFORMED AND WAS NOT FUNCTIONAL. AT THIS TIME THERE IS NO INFO CONFIRMING THE NEED FOR DECANNULATION AND RECANNULATION OF A REPLACEMENT TUBE. COVIDIEN HAS MADE ATTEMPTS TO GATHER FURTHER DETAILS SURROUNDING THE CIRCUMSTANCES OF THIS REPORT WITH NO RESPONSE TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    116439 MALLINCKRODT ENDOBRONCHIAL TUBE LEFT/RIGHT BTS COVIDIEN/ FORMERLY TYCO 20111047X

    Patients

    Seq Age Sex Outcome Treatment
    1