BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SHILEY, 8DCT 7.6 MM ID 12.2 MM OD 79.0 MM L

    MDR report key: 1220684 · Received October 31, 2008

    Report

    Report Number
    MW5008857
    Event Type
    Injury
    Date Received
    October 31, 2008
    Date of Event
    September 24, 2008
    Report Date
    October 30, 2008
    Manufacturer
    NELLCOR
    Product Code
    BTO
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    VA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    TRACHEOSTOMY BROKE OFF AT FLANGE WHILE ATTACHED TO PATIENT. PHYSICIAN WAS ABLE TO TEMPORARILY REPAIR THE DEVICE WITH A STERILE SURGICAL ADHESIVE UNTIL THE PATIENT WAS STABLE ENOUGH TO REPLACE THE TRACH. THE HUB SEPARATED FROM THE OUTER CANNULA AT THE OUTER CANNULA WAS STILL ATTACHED TO THE FLANGE BY A PIVOT ON EACH SIDE THUS PREVENTING IT FROM MIGRATING DEEPER INTO THE PATIENT'S AIRWAY, ALTHOUGH IN THIS CASE THE INNER CANNULA COULD SEPARATE FROM THE PATIENT'S AIRWAY. IN 2004, THERE WERE SIMILAR INCIDENTS WITH THE SHILEY. TRACHEOSOFT XLT EXTENDED LENGTH TRACHEOSTOMY TUBE AFTER WHICH THE PRODUCT WAS RECALLED. THE RECALL WAS PROMPTED BY REPORTS OF THE OUTER CANNULA SEPARATING FROM THE HUB AND SWIVEL NECK PLATE. IF THIS FAILURE MODE DOES OCCUR. THE OUTER CANNULA COULD TRAVEL INTO THE PATIENT'S AIRWAY, POTENTIALLY INTERFERING WITH BREATHING OR VENTILATION AND RESULTING IN SERIOUS INJURY OR DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SHILEY, 8DCT 7.6 MM ID 12.2 MM OD 79.0 MM L TRACHEOSTOMY TUBE BTO NELLCOR 8DCT 0802000385

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R MAQUETTE SERVOI VENTILATOR| FISHER PAYKAL UNIVERSAL PATIENT CIRCUIT