BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MALLINCKRODT

    MDR report key: 4113700 · Received September 15, 2014

    Report

    Report Number
    2936999-2014-00813
    Event Type
    Malfunction
    Date Received
    September 15, 2014
    Date of Event
    August 19, 2014
    Report Date
    August 21, 2014
    Manufacturer
    COVIDIEN
    Product Code
    BTS
    PMA / PMN Number
    K771219
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 1

    CUSTOMER STATES: PRIOR TO USE, THE INCOMPLETE DEFLATION OF THE CUFF WAS CONFIRMED. NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    569363 MALLINCKRODT TRACHEAL TUBE BTS COVIDIEN 201403233X

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown