BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CIAGLIA BLUE RHINO PERCUTANEOUS TRACHEOSTOMY INTRODUCER TRAY

    MDR report key: 1725280 · Received June 10, 2010

    Report

    Report Number
    1820334-2010-00258
    Event Type
    Injury
    Date Received
    June 10, 2010
    Date of Event
    April 12, 2010
    Report Date
    May 11, 2010
    Manufacturer
    COOK INC
    Product Code
    KCG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    EXPIRATION - UNKNOWN AS LOT IS UNKNOWN. (B)(4). THE COMPLAINT DEVICE WAS RETURNED IN A CONTAMINATED AND USED CONDITION. UPON EXAMINATION OF THE DEVICE, IT WAS CONFIRMED THAT THE FLANGE HAD SEPARATED FROM THE TRACHEOSTOMY TUBE. INSTRUCTIONS FOR USE (IFU) DETAILS APPROPRIATE PLACEMENT AND USAGE TECHNIQUES. APPROPRIATE DESIGN CONTROL ACTIVITIES HAVE BEEN COMPLETED IN RELATION TO THIS PRODUCT LINE. THE TRACHEOSTOMY TUBE IS SUPPLIED BY AN APPROVED VENDOR. THE VENDOR HAS BEEN NOTIFIED OF THESE TYPES OF COMPLAINTS. HE STATED THAT AN UPDATED FIXTURE WAS IMPLEMENTED IN RELATION TO THIS ISSUE IN SEPTEMBER 2009, AND THAT PULL TESTS ARE PERFORMED IN-PROCESS TO CONFIRM THE UNITS ARE HOLDING AS SPECIFIED. ADDITIONALLY, HE INFORMED US THAT HISTORICALLY THEY RECEIVE APPROXIMATELY 10 COMPLAINTS PER MILLION RELATING TO THIS FAILURE MODE. UPON EXAMINATION OF THE PRODUCT, THE TRACHEOSTOMY TUBE WAS CONFIRMED TO BE SEPARATED FROM THE FLANGE. THE SHILEY LOT NUMBER INVOLVED IN THIS INCIDENT IS 0811000137, WHICH WAS RECENTLY RECALLED DUE TO ISSUES WITH THE PILOT BALLOON ASSEMBLY. THE COOK INC. LOT NUMBER WAS NOT PROVIDED. THE COMPONENT VENDOR HAS BEEN NOTIFIED IN REGARDS TO THIS FAILURE MODE. WE WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS. APPROPRIATE INDIVIDUALS HAVE BEEN NOTIFIED.

    Description of Event or Problem · 1

    PATIENT HAD A #8 TRACH PUT IN AT BEDSIDE (B)(6) 2010. OUTER CANNULA OF TRACH WAS BROKEN AWAY FROM PLATE. TRACH COULD NOT SLIDE IN OR OUT OF THE ORIFICE. HELD TRACH IN PLACE AND CALLED TRAUMA PHYSICIAN. PATIENT WENT TO OPERATING ROOM TO HAVE TRACH REPLACED. SINCE NEW TRACH, PATIENT HAS BEEN FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CIAGLIA BLUE RHINO PERCUTANEOUS TRACHEOSTOMY INTRODUCER TRAY KCG DILATOR, TRACHEAL KCG COOK INC NA UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention