BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SHILEY DCT

    MDR report key: 1033374 · Received April 23, 2008

    Report

    Report Number
    2936999-2008-00183
    Event Type
    Injury
    Date Received
    April 23, 2008
    Date of Event
    March 28, 2008
    Report Date
    March 28, 2008
    Product Code
    BTO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RETURN OF THE SIZE 8 DISPOSABLE CANNULA TRACHEOSTOMY TUBE FOR FAILURE INVESTIGATION HAS BEEN REQUESTED. THE LOT NUMBER WAS PROVIDED AND THE MFR WILL REVIEW THE LOT HISTORY RECORDS. IF THE TUBE IS RETURNED AND FAILURE INVESTIGATION OBTAINS SIGNIFICANT RESULTS, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    A COMPANY REP CALLED TO REPORT A FACILITY HAD A SIZE 8 DISPOSABLE TRACHEOSTOMY TUBE IN WHICH THE TUBE HAD SEPARATED FROM THE FLANGE. THE TRACHEOSTOMY TUBE HAD BEEN IN USE FOR 6 DAYS. THE PT USES A VENTILATOR. A CONTACT FOR THE FACILITY WAS PROVIDED AND CLINICAL COORDINATOR OF THE RESPIRATORY DEPARTMENT WAS THEN CONTACTED FOR FURTHER INFO. THE CLINICAL COORDINATOR STATED, THAT THE TRACHEOSTOMY TUBE BROKE OFF FROM THE FLANGE AT THE TWO TEETH THAT HOLD THE FLANGE IN PLACE. THE PT DESATED, AND IS NOW USING A REPLACEMENT SIZE 8 DISPOSABLE TRACHEOSTOMY TUBE. THE TRACHEOSTOMY TUBE HAD BEEN IN USE FOR 5 DAYS. TRACHEOSTOMY TUBES ARE NORMALLY CHECKED OR CHANGED EVERY 7 DAYS, WITH THE INNER CANNULA REPLACED DAILY. NO CLEANING OR RE-STERILIZATION WAS DONE. THE PT IS ON A VENTILATOR 24/7 USING A PURITAN BENNETT 840.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SHILEY DCT DISPOSABLE CANNULA TRACHEOSTOMY TUBE BTO DCT 0707002220

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention