BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MALLINCKRODT

    MDR report key: 5133652 · Received October 7, 2015

    Report

    Report Number
    2936999-2015-00863
    Event Type
    Malfunction
    Date Received
    October 7, 2015
    Date of Event
    September 9, 2015
    Report Date
    September 11, 2015
    Manufacturer
    COVIDIEN
    Product Code
    BTS
    PMA / PMN Number
    K771219
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    COVIDIEN REFERENCE: (B)(4). THE ENDOBRONCHIAL TUBE WAS RETURNED FOR INVESTIGATION. THE REPORTED DEFECT COULD BE DETECTED ON THE RETURNED SAMPLE. THE RETURNED SAMPLE FUNCTIONED AS INTENDED.

    Additional Manufacturer Narrative · 1

    (B)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PRIOR TO PATIENT USE, AN INCOMPLETE DEFLAITON OF AN ENDOBRONCHIAL TUBE CUFF WAS CONFIRMED. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    664214 MALLINCKRODT ENDOBRONCHIAL TUBE BTS COVIDIEN 125037 201412063X

    Patients

    Seq Age Sex Outcome Treatment
    1