BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MALLINCKRODT

    MDR report key: 3032430 · Received March 29, 2013

    Report

    Report Number
    2936999-2013-00239
    Event Type
    Injury
    Date Received
    March 29, 2013
    Date of Event
    February 26, 2013
    Report Date
    February 28, 2013
    Manufacturer
    COVIDIEN, FORMERLY NELLCOR PURITAN BENNETT, INC.
    Product Code
    BTS
    PMA / PMN Number
    K771219
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    COVIDIEN IS ATTEMPTING TO COLLECT THE SAMPLES AND PHOTOS ASSOCIATED TO THIS REPORT.

    Description of Event or Problem · 1

    CUSTOMER REPORTS THAT WHEN GOING TO PLACE THE TUBE IN THE PATIENT¿S TRACHEA, THEY OBSERVED THAT IT IS DIFFICULT TO PLACE THE TUBE. SO THEY REALIZED THAT INSTEAD OF BEING A 37FR TUBE AS IT STATED IN ITS BOX, IT WAS 41FR. THE CUSTOMER REPORTED THAT THE OUTSIDE BOX LABEL DID NOT MATCH THE INSIDE PRODUCT. THEY GOT ANOTHER BOX AND CHECKED THAT IT HAPPENED THE SAME. THE REPORT SUGGEST THAT THIS WAS PRIOR TO INSERTION BUT IT DID CAUSE A DELAY IN TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    129847 MALLINCKRODT ENDOBRONCHIAL TUBE LEFT/RIGHT BTS COVIDIEN, FORMERLY NELLCOR PURITAN BENNETT, INC. 201211011X

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention