BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SHILEY DISPOSABLE CANNULA LOW PRESSURE

    MDR report key: 2223933 · Received August 17, 2011

    Report

    Report Number
    2936999-2011-00528
    Event Type
    Injury
    Date Received
    August 17, 2011
    Date of Event
    July 1, 2011
    Report Date
    July 20, 2011
    Manufacturer
    COVIDIEN/FORMERLY TYCO HEALTHCARE
    Product Code
    JOH
    PMA / PMN Number
    K962173
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION OF THE RETURNED SAMPLE IS CURRENTLY IN PROGRESS. IF SIGNIFICANT INFO IS IDENTIFIED FROM THE INVESTIGATION, A SUMMARY OF THE FINDINGS WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    THE CALLER STATED THE PT HAD A NEW TRACH PLACED YESTERDAY AND TODAY WHILE REPLACING THE INNER CANNULA THE FLANGE DISCONNECTED FROM THE OUTER CANNULA AND CAME OUT WITH THE INNER CANNULA. THE FLANGE THAT DISCONNECTED WAS THEN CONNECTED TO THE TRACH WITH A RED TIE BY THE ENT PHYSICIAN. THEY WILL BE REMOVING THE TRACH NEXT WEEK, AND THIS WILL BE A REINTUBATION SINCE THE TRACH IS BEING REPLACED UNDER THE 29 DAYS AND FOR THE FAILURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SHILEY DISPOSABLE CANNULA LOW PRESSURE TRACHEOSTOMY TUBE JOH COVIDIEN/FORMERLY TYCO HEALTHCARE 110101895X

    Patients

    Seq Age Sex Outcome Treatment
    1