BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MALLINCKRODT

    MDR report key: 3942083 · Received March 4, 2014

    Report

    Report Number
    2936999-2014-00204
    Event Type
    Malfunction
    Date Received
    March 4, 2014
    Date of Event
    February 3, 2014
    Report Date
    February 4, 2014
    Manufacturer
    COVIDIEN
    Product Code
    BTS
    PMA / PMN Number
    K771219
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    NURSE
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). COVIDIEN IS ATTEMPTING TO COLLECT SAMPLE FOR FAILURE ANALYSIS. IF THE SAMPLE IS RECEIVED, A SUMMARY OF THE INVESTIGATION RESULTS WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    CUSTOMER REPORTS DURING PRE-TEST, A NURSE NOTICED THE BALLOON IN THE BRONCO-CATH CUFF DID NOT DEFLATE. COVIDIEN IS ATTEMPTING TO GATHER FURTHER DETAILS ASSOCIATED TO THE CIRCUMSTANCES OF THIS REPORT. INVESTIGATION EFFORTS ARE ONGOING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    129797 MALLINCKRODT ENDOBRONCHIAL TUBE LEFT/RIGHT BTS COVIDIEN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown