BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SHILEY DISPOSABLE CANNULA LOW PRESSURE

    MDR report key: 1821491 · Received August 25, 2010

    Report

    Report Number
    2936999-2010-01137
    Event Type
    Injury
    Date Received
    August 25, 2010
    Date of Event
    July 1, 2010
    Report Date
    July 28, 2010
    Manufacturer
    COVIDIEN, FORMERLY TYCO HEALTHCARE
    Product Code
    JOH
    PMA / PMN Number
    K962173
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOT NUMBER IS UNK AND THEREFORE, THE DATE OF MANUFACTURE CANNOT BE DETERMINED. THE TUBE WAS DISCARDED AND THEREFORE UNAVAILABLE FOR FAILURE INVESTIGATION.

    Description of Event or Problem · 1

    THE CALLER STATED THAT THEY COULD NOT DEFLATE THE CUFF ON A DCT TRACHEOSTOMY TUBE. THE CALLER WAS THE MOTHER OF THE PT CALLING FROM HOME. THE SIZE OF THE TUBE IS UNK, AND NO LOT NUMBER OR EXPIRATION DATE WAS AVAILABLE. THE TUBE HAD BEEN IN USE FOR 3 WEEKS, AND THEY WERE TRYING TO DEFLATE THE CUFF IN ORDER TO HAVE THE PT USE A SPEAKING VALVE. THEY CUT THE PILOT BALLOON LINE AND THEN USED A SYRINGE TO REMOVE THE AIR, AND THE CALLER STATED THAT THIS WORKED. THIS ISSUE REQUIRED RECANNULATION THAT WAS NOT A PART OF THE PT'S REGULAR TRACHEOSTOMY TUBE CHANGING SCHEDULE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SHILEY DISPOSABLE CANNULA LOW PRESSURE TRACHEOSTOMY TUBE JOH COVIDIEN, FORMERLY TYCO HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention