BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SHILEY

    MDR report key: 3130186 · Received May 21, 2013

    Report

    Report Number
    2936999-2013-00377
    Event Type
    Malfunction
    Date Received
    May 21, 2013
    Date of Event
    April 1, 2013
    Report Date
    April 22, 2013
    Manufacturer
    COVIDIEN
    Product Code
    JOH
    PMA / PMN Number
    K945513
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE IS EXPECTED TO BE RETURNED FOR ANALYSIS.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTS: THE CURVE OF THE DEVICE WAS NOT CORRECT AND IT COULD NOT BE INTRODUCED INSIDE THE TRACHEA OF THE PT. ANOTHER DEVICE NEEDED TO BE USED INSTEAD. THE REPORTED EVENT DID NOT REQUIRE DECANNULATION, THE INFO SUGGEST THAT IT COULD NOT BE INTRODUCED. COVIDIEN IS ATTEMPTING TO GATHER FURTHER DETAILS SURROUNDING THE CIRCUMSTANCES OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    225661 SHILEY PEDIATRIC TRACH TUBE JOH COVIDIEN 120300598X

    Patients

    Seq Age Sex Outcome Treatment
    1