BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SHILEY LOW PRESSURE CUFFED

    MDR report key: 1101806 · Received August 6, 2008

    Report

    Report Number
    2936999-2008-00352
    Event Type
    Injury
    Date Received
    August 6, 2008
    Date of Event
    July 9, 2008
    Report Date
    July 9, 2008
    Manufacturer
    COVIDIEN/FORMERLY TYCO HEALTHCARE
    Product Code
    BTO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RETURN OF THE TRACHEOSTOMY TUBE FOR FAILURE INVESTIGATION HAS BEEN REQUESTED. THE LOT NUMBER IS UNK. NO ANALYSIS OR CONCLUSIONS CAN BE DRAWN WITHOUT THE DEVICE OR THE LOT NUMBER. IF THE TUBE IS RETURNED AND FAILURE INVESTIGATION RESULTS PROVIDE SIGNIFICANT INFO, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INNER CANNULA DOESN'T STAY LOCKED IN. THE TUBE WAS IN THE PT FOR ALMOST 30 DAYS, AND IT WAS TIME TO BE CHANGED TO A NEW TUBE. THE PT CHANGED IT TO ANOTHER 8LPC.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention