BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SHILEY LOW PRESSURE CUFFED

    MDR report key: 2172607 · Received July 19, 2011

    Report

    Report Number
    2936999-2011-00487
    Event Type
    Injury
    Date Received
    July 19, 2011
    Date of Event
    June 1, 2011
    Report Date
    June 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
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE TUBE WAS DISCARDED THEREFORE, UNAVAILABLE FOR FAILURE INVESTIGATION. NO CONCLUSIONS CAN BE DRAWN WITHOUT THE DEVICE. THE DEVICE HISTORY RECORD FOR THE LOT NUMBER PROVIDED WILL BE REVIEWED. INFO HAS BEEN ADDED TO THE DATABASE FOR TRENDING PURPOSES. THIS REPORT IS FOR THE SECOND OF TWO TUBES FROM ONE CUSTOMER AS REFERENCED IN ASSOCIATED REPORT 2936999-2011-00485.

    Description of Event or Problem · 1

    THE CALLER STATED THAT OVER THE LAST 2 WEEKS, THE PT HAD TO REPLACE THE TRACHEOSTOMY TUBE PRIOR TO 29 DAYS OF RECOMMENDED USE, DUE TO LEAKAGE BETWEEN THE HUB AND THE INNER CANNULA WITH THE LOCK NOT SNAPPING CLOSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SHILEY LOW PRESSURE CUFFED TRACHEOSTOMY TUBE JOH COVIDIEN/FORMERLY TYCO HEALTHCARE 1007001838

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention