BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SHILEY TRACHEOSTOMY TUBE

    MDR report key: 1033383 · Received April 23, 2008

    Report

    Report Number
    MW5006362
    Event Type
    Injury
    Date Received
    April 23, 2008
    Date of Event
    April 22, 2008
    Report Date
    April 23, 2008
    Manufacturer
    NELLCOR/TYCO HEALTHCARE
    Product Code
    BTO
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MD, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    A #8 SHILEY DCT TRACHEOSTOMY TUBE OUTER CANNULA SEPARATED FROM THE HUB AND THE NECK FLANGE DISLODGING THE INNER CANNULA. TRACH HAD TO BE EMERGENCTLY REPLACED. THIS SAME TYPE OF INCIDENT OCCURRED WITH SHILEY #6 TRACHEOSTOMY TUBE IN 2006 AND WAS REPORTED TO THE MFR AND FDA THROUGH MED WATCH. DATES OF USE: 2008. DIAGNOSIS OR REASON FOR USE: CHRONIC RESPIRATORY FAILURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SHILEY TRACHEOSTOMY TUBE TRACHEOSTOMY TUBE BTO NELLCOR/TYCO HEALTHCARE #8 0708000202

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability