BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SHILEY

    MDR report key: 3072519 · Received April 17, 2013

    Report

    Report Number
    2936999-2013-00295
    Event Type
    Malfunction
    Date Received
    April 17, 2013
    Date of Event
    March 1, 2013
    Report Date
    March 19, 2013
    Manufacturer
    COVIDIEN
    Product Code
    JOH
    PMA / PMN Number
    K945513
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION NOT YET AVAILABLE, INVESTIGATION IN PROGRESS.

    Description of Event or Problem · 1

    THE REPORTER STATES THAT THE SURFACE OF THE CANNULA IS VERY ROUGH AT SOME PLACES. THE REPORTER CONFIRMED THIS WAS DISCOVERED PRIOR TO PT USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    164725 SHILEY LONG PEDIATRIC TRACH TUBE JOH COVIDIEN 1101002420

    Patients

    Seq Age Sex Outcome Treatment
    1