BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MALLINCKRODT

    MDR report key: 2833474 · Received October 30, 2012

    Report

    Report Number
    2936999-2012-00565
    Event Type
    Malfunction
    Date Received
    October 30, 2012
    Date of Event
    October 9, 2012
    Report Date
    October 15, 2012
    Manufacturer
    COVIDIEN, FORMERLY TYCO HEALTHCARE
    Product Code
    BTS
    PMA / PMN Number
    K771219
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION NOT YET AVAILABLE. PENDING RECEIPT OF SAMPLE FOR INVESTIGATION.

    Description of Event or Problem · 1

    CUSTOMER STATES: PRIOR TO USE ON A PT DURING PRE-TEST A NURSE CONFIRMED THE TRACHEAL CUFF WOULD NOT BE DEFLATED COMPLETELY. CUSTOMER CONFIRMED NO PT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MALLINCKRODT ENDOBRONCHIAL TUBE LEFT/RIGHT BTS COVIDIEN, FORMERLY TYCO HEALTHCARE 20123405X

    Patients

    Seq Age Sex Outcome Treatment
    1