BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MALLINCKRODT

    MDR report key: 3042938 · Received March 6, 2013

    Report

    Report Number
    2936999-2013-00166
    Event Type
    Malfunction
    Date Received
    March 6, 2013
    Date of Event
    February 1, 2013
    Report Date
    February 6, 2013
    Manufacturer
    COVIDIEN, FORMERLY TYCOHEA
    Product Code
    BTR
    PMA / PMN Number
    K871204
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    THE CALLER, ANESTHESIA TECHNICIAN, CONFIRMED THE TUBE FAILED LEAK TESTING. CALLER CONFIRMED THAT THE SAMPLE FAILED DURING TESTING OF STOCK FOR THE REPORTED PRODUCT WITH NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    96476 MALLINCKRODT HI-LO TRACHEAL TUBE BTR COVIDIEN, FORMERLY TYCOHEA 12K0254JZX

    Patients

    Seq Age Sex Outcome Treatment
    1