BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MALLINCKRODT

    MDR report key: 3901973 · Received February 21, 2014

    Report

    Report Number
    2936999-2014-00168
    Event Type
    Malfunction
    Date Received
    February 21, 2014
    Date of Event
    January 1, 2014
    Report Date
    January 22, 2014
    Manufacturer
    COVIDIEN
    Product Code
    BTR
    PMA / PMN Number
    K871204
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). SAMPLE HAS BEEN REQUESTED FROM CUSTOMER, IF THE SAMPLE IS RECEIVED, A SAMPLE OF A INVESTIGATION RESULTS WILL BE PROVIDED IN A SUPPLEMENTAL REPORT. REFERENCING RELATED MEDWATCH REPORT: 2936999-2014-00169.

    Description of Event or Problem · 1

    CALLER REPORTED THE CUSTOMER HAD TO INSERT THE NASOTRACHEAL TUBE BEYOND THE NORMAL BEND POINT FOR AN EFFECTIVE SEAL. 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
    110988 MALLINCKRODT 7.5 LO-PRO MURPHY TRACHEAL TUBE BTR COVIDIEN 13H0492JZX

    Patients

    Seq Age Sex Outcome Treatment
    1