BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MALLINCKRODT

    MDR report key: 3727113 · Received January 24, 2014

    Report

    Report Number
    2936999-2014-00054
    Event Type
    Malfunction
    Date Received
    January 24, 2014
    Date of Event
    December 1, 2013
    Report Date
    December 27, 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). MANUFACTURER INDICATED LOT 1009002759 BELONGS TO BRAND NAME: MALLINCKRODT, COMMON DEVICE NAME: 2.0 NASAL RAE TRACHEAL TUBE, CATALOG #86214, PMA/510 (K) # K871204. COVIDIEN HAS ATTEMPTED TO GATHER FURTHER DETAILS SURROUNDING THE CIRCUMSTANCES OF THIS REPORT, WITHOUT SUCCESS. NO SAMPLE IS EXPECTED TO BE RETURNED. WITHOUT THE ACTUAL COMPLAINT SAMPLE A FULL INVESTIGATION CANNOT BE COMPLETED THEREFORE, WE ARE UNABLE TO DETERMINE THE CAUSE FOR THIS SPECIFIC EVENT. WE ARE UNABLE TO DETERMINE THE EXACT CAUSE FOR THIS SPECIFIC EVENT, HOWEVER, MANUFACTURING CONTROLS ARE IN PLACE TO DETECT RELATED ISSUES AND TO REDUCE THE POTENTIAL FOR OCCURRENCE DURING THE MANUFACTURING PROCESS. INFO OF THIS NATURE IS INCLUDED IN OUR DATABASE AND MONITORED THROUGH TRENDING.

    Description of Event or Problem · 1

    CUSTOMER REPORTED CUFF WILL NOT INFLATE. COVIDIEN HAS ATTEMPTED TO GATHER FURTHER DETAILS SURROUNDING THE CIRCUMSTANCES OF THIS REPORT. WITHOUT SUCCESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    55724 MALLINCKRODT 7.0 HI-LO TRACHEAL TUBE BTR COVIDIEN 1009002759

    Patients

    Seq Age Sex Outcome Treatment
    1