BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SHILEY FEN LPC

    MDR report key: 1063448 · Received June 20, 2008

    Report

    Report Number
    2936999-2008-00299
    Event Type
    Injury
    Date Received
    June 20, 2008
    Date of Event
    May 15, 2008
    Report Date
    May 26, 2008
    Manufacturer
    COVIDIEN, FORMERLY TYCO HEALTHCARE
    Product Code
    BTO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RETURN OF THE FENESTRATED TRACHEOSTOMY TUBE FOR FAILURE INVESTIGATION HAS BEEN REQUESTED. THE LOT NUMBER WAS PROVIDED AND THE MFR WILL REVIEW THE LOT HISTORY RECORDS. A MFG CAPA IS ALREADY IN PLACE TO ADDRESS CUFF LEAKS. IF THE TUBE IS RETURNED AND FAILURE INVESTIGATION RESULTS PROVIDE SIGNIFICANT INFO, A FOLLOW-UP REPORT WILL BE SUBMITTED. THE MFR'S DIRECTIONS FOR USE STATES UNDER: CAUTION. TO EASE INSERTION AND TO GUARD AGAINST CUFF PERFORATION FROM SHARP EDGES OF CARTILAGE, THE CUFF SHOULD BE TAPERED BACK. THIS CAN BE ACCOMPLISHED BY FIRST INFLATING THE CUFF. THEN GENTLY MOVE THE CUFF AWAY FROM THE DISTAL TIP OF THE OUTER CANNULA TOWARDS THE SWIVEL NECK PLATE AS THE RESIDUAL AIR IS REMOVED BY DEFLATION. DO NOT USE ANY SHARP INSTRUMENTS SUCH AS FORCEPS OR HEMOSTATS THAT WOULD DAMAGE THE CUFF WHEN TAPERING IT. THE MFR'S DIRECTIONS FOR USE STATES UNDER: INSTRUCTIONS: 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. 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

    IT WAS REPORTED THAT DURING USE THE CUFF ON THE SHILEY FENESTRATED LOW PRESSURE CUFFED TRACHEOSTOMY TUBE LEAKED. THE TUBE WAS REMOVED AND THE PT WAS RE-INTUBATED. THE CUFF WAS PRE-TESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SHILEY FEN LPC TRACHEOSTOMY TUBE BTO COVIDIEN, FORMERLY TYCO HEALTHCARE 0709000882

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention