BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SHILEY

    MDR report key: 2833482 · Received October 30, 2012

    Report

    Report Number
    2936999-2012-00575
    Event Type
    Malfunction
    Date Received
    October 30, 2012
    Date of Event
    October 1, 2012
    Report Date
    October 15, 2012
    Manufacturer
    COVIDIEN, FORMERLY TYCO HEALTHCARE
    Product Code
    BTO
    PMA / PMN Number
    K811447
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION NOT YET AVAILABLE. PENDING RECEIPT OF SAMPLE FOR INVESTIGATION.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT INNER CANNULA IS NOT LATCHING SECURELY AND HAS THE POTENTIAL TO DISCONNECT FROM THE VENT CIRCUIT DURING PT USE. THE CALLER CONFIRMED THAT THIS WAS IDENTIFIED PRIOR TO PT USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SHILEY DISPOSABLE INNER CANNULA BTO COVIDIEN, FORMERLY TYCO HEALTHCARE 110201684X

    Patients

    Seq Age Sex Outcome Treatment
    1