BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MALLINCKRODT

    MDR report key: 3030213 · Received March 27, 2013

    Report

    Report Number
    2936999-2013-00220
    Event Type
    Injury
    Date Received
    March 27, 2013
    Date of Event
    February 26, 2013
    Report Date
    February 26, 2013
    Manufacturer
    COVIDIEN, FORMERLY TYCO HEALTHCARE
    Product Code
    BTR
    PMA / PMN Number
    K871204
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    CALLER, REPRESENTATIVE OF PURCHASING, CALLED IN A REPORT THAT THE TUBE DEVELOPED A LEAK CUFF DURING PT USE. THE CALLER CONFIRMED DECANNULATION/RECANNULATION OF A REPLACEMENT TUBE WAS REQUIRED. THE CALLER REPORTED THAT NO FURTHER DETAILS SURROUNDING THE CIRCUMSTANCES OF THIS REPORT ARE AVAILABLE. NO SAMPLE AVAILABLE FOR ANALYSIS. THIS REPORT IS ASSOCIATED TO THE FOURTH OCCURRENCE REPORTED ON MDR #2936999-2013-00217.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    125754 MALLINCKRODT HI/LO TRACHEAL TUBE BTR COVIDIEN, FORMERLY TYCO HEALTHCARE 110900144X

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention