BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SHILEY 5.5PLC CUFFED LONG

    MDR report key: 1230228 · Received November 12, 2008

    Report

    Report Number
    2936999-2008-00559
    Event Type
    Injury
    Date Received
    November 12, 2008
    Date of Event
    October 1, 2008
    Report Date
    October 15, 2008
    Manufacturer
    COVIDIEN/FORMERLY TYCO
    Product Code
    BTO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE CALLER REPORTED THAT TUBE DEVELOPED A LEAK AFTER 5 DAYS TO 2 WEEKS OF USE. THE CALLER WAS NOT CERTAIN ABOUT THE LOCATION OF THE LEAK; IT COULD BE THE CUFF OR THE PILOT LINE OR VALVE. WHEN THE LEAK WAS DISCOVERED, THE TUBE WAS REMOVED AND ANOTHER 5.5 LPC WAS INSERTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SHILEY 5.5PLC CUFFED LONG TRACHEOSTOMY TUBE BTO COVIDIEN/FORMERLY TYCO

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention