BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SHILEY DISPOSABLE CANNULA FENESTRATED

    MDR report key: 1471333 · Received September 10, 2009

    Report

    Report Number
    2936999-2009-00526
    Event Type
    Injury
    Date Received
    September 10, 2009
    Date of Event
    August 15, 2009
    Report Date
    August 19, 2009
    Manufacturer
    COVIDIEN/FORMERLY TYCO HEALTHCARE
    Product Code
    BTO
    PMA / PMN Number
    K843729
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE CALLER STATED THAT A PT WAS USING AN 8DFEN TRACHEOSTOMY TUBE WHERE A PIECE OF THE OUTER CANNULA AND DISPOSABLE INNER CANNULA (DIC) CLIPS BROKE OFF. THIS OCCURRED IN 2009. THIS NECESSITATED RE INTUBATION WITH ANOTHER 8DFEN TRACHEOSTOMY TUBE. THE TRACHEOSTOMY TUBE HAD BEEN IN USE 17 DAYS, AND THE RE INTUBATION WAS NOT A PART OF A ROUTINE TRACHEOSTOMY TUBE CHANGE. THE PT DOES NOT HAVE ANY UNUSUAL ANATOMICAL ANOMALIES. THE DIC IS CHANGED TWICE DAILY. LUBRICATION WAS USED DURING INTUBATION. THERE IS NO LOT NUMBER AVAILABLE, AND THE TRACHEOSTOMY TUBE IS NOT AVAILABLE FOR RETURN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SHILEY DISPOSABLE CANNULA FENESTRATED TRACHEOSTOMY TUBE BTO COVIDIEN/FORMERLY TYCO HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention