BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SHILEY FEN L-P-C

    MDR report key: 1040438 · Received May 7, 2008

    Report

    Report Number
    2936999-2008-00202
    Event Type
    Injury
    Date Received
    May 7, 2008
    Date of Event
    April 4, 2008
    Report Date
    April 14, 2008
    Manufacturer
    COVIDIEN/FORMERLY TYCO
    Product Code
    BTO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    WE HAVE REQUESTED THAT IF AVAILABLE THE TUBE BE RETURNED FOR FAILURE INVESTIGATION. THE LOT NUMBER WAS PROVIDED AND THE MANUFACTURER WILL REVIEW THE LOT HISTORY RECORDS. IF THE TUBE IS RETURNED AND FAILURE INVESTIGATION RESULTS PROVIDE SIGNIFICANT INFORMATION, A FOLLOW-UP REPORT WILL BE SUBMITTED. A MANUFACTURING CAPA IS ALREADY IN PLACE TO ADDRESS CUFF LEAKS. THE MANUFACTURER'S DFU STATES UNDER INSTRUCTIONS, TUBE PREPARATION: WITH SHILEY CUFFED MODELS (LPC, FEN) THE CUFF AND INFLATION SYSTEM SHOULD BE TESTED FOR LEAKAGE BEFORE INSERTING THE TUBE. THIS TEST CAN BE PERFORMED AS FOLLOWS: INFLATE THE CUFF WITH THE VOLUME OF AIR INDICATED IN TABLE 1. THEN EITHER OBSERVE FOR DEFLATION OVER SEVERAL MINUTES OR IMMERSE THE TUBE IN STERILE SALINE AND OBSERVE FOR AIR LEAKAGE. DEFLATE THE CUFF PRIOR TO INSERTION.

    Description of Event or Problem · 1

    A COMPANY REPRESENTATIVE REPORTED, A PT WITH A SHILEY FENESTRATED LOW PRESSURE CUFFED TRACHEOSTOMY TUBE EXPERIENCED A CUFF LEAK. THE TUBE WAS REMOVED AND REPLACED WITH AN UNK MODEL TRACHEOSTOMY TUBE. NO OTHER PT INFORMATION WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SHILEY FEN L-P-C TRACHEOSTOMY TUBE LOW PRESSURE BTO COVIDIEN/FORMERLY TYCO 6FEN 0801001911

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention