BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MALLINCKRODT

    MDR report key: 3240884 · Received July 17, 2013

    Report

    Report Number
    2936999-2013-00524
    Event Type
    Malfunction
    Date Received
    July 17, 2013
    Date of Event
    June 1, 2013
    Report Date
    June 17, 2013
    Manufacturer
    COVIDIEN
    Product Code
    BTR
    PMA / PMN Number
    K871204
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). COVIDIEN IS IN THE PROCESS OF OBTAINING FURTHER INFORMATION SURROUNDING THE CIRCUMSTANCES OF THIS REPORT. IF FURTHER INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE PROVIDED. MANUFACTURING CONTROLS ARE IN PLACE TO DETECT RELATED DEFECTS AND REDUCE THE POTENTIAL FOR OCCURRENCE DURING THE MANUFACTURING PROCESS. INFORMATION HAS BEEN ADDED TO THE DATABASE FOR TRENDING PURPOSES.

    Description of Event or Problem · 1

    COVIDIEN RECEIVED A REPORT THAT THE BALLOON ON THE TRACHEAL TUBE WAS DYSFUNCTIONAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    332001 MALLINCKRODT 8.0 HI-LO TRACHEAL TUBE BTR COVIDIEN UNK

    Patients

    Seq Age Sex Outcome Treatment
    1