BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SHILEY DISPOSABLE CANNULA LOW PRESSURE

    MDR report key: 1665724 · Received April 20, 2010

    Report

    Report Number
    2936999-2010-00732
    Event Type
    Injury
    Date Received
    April 20, 2010
    Date of Event
    January 12, 2009
    Report Date
    April 19, 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
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE TUBE LASTED FROM (B) (6) 2008 TO (B) (6) 2009 (20 DAYS) AND THAT THE PILOT BALLOON AND THE CUFF DID NOT INFLATE ON FIRST ATTEMPT AND ON SECOND ATTEMPT WHEN PREPARING TO GO ON TO HER VENTILATOR. A NON-ROUTINE REPLACEMENT OF THE TUBE WAS REQUIRED. THE CUSTOMER ALSO REPORTED THAT THE PT HAD PAIN AND CONGESTION POST INCIDENT AND COMPLAINED OF "TOXIC FUMES" AND THAT SHE COULD TASTE THE PLASTIC WHEN BREATHING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SHILEY DISPOSABLE CANNULA LOW PRESSURE TRACHEOSTOMY TUBE JOH COVIDIEN/FORMERLY TYCO HEALTHCARE 0802002041

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention