BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SHILEY DISPOSABLE CANNULA LOW PRESSURE

    MDR report key: 1880266 · Received October 19, 2010

    Report

    Report Number
    2936999-2010-01218
    Event Type
    Injury
    Date Received
    October 19, 2010
    Date of Event
    September 19, 2010
    Report Date
    September 20, 2010
    Manufacturer
    COVIDIEN/ FORMERLY TYCO HEALTHCARE
    Product Code
    JOH
    PMA / PMN Number
    K962173
    Removal / Correction Number
    Z-1463-2010
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE TUBE REPORTED IN THIS EVENT WAS INITIALLY REPORTED TO BE AVAILABLE, HOWEVER, TO DATE THE CUSTOMER HAS NOT RETURNED IT. (B)(4).

    Description of Event or Problem · 1

    CALLER STATES THAT PILOT BALLOON DOES NOT STAY INFLATED. THE PT HAD A SCHEDULED TRACHEOSTOMY TUBE REPLACEMENT LAST FRIDAY NIGHT (B)(6)2010 AND THE PILOT BALLOON DID NOT HOLD AIR AND WAS REPLACED ON SUNDAY (B)(6)2010.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SHILEY DISPOSABLE CANNULA LOW PRESSURE TRACHEOSTOMY TUBE JOH COVIDIEN/ FORMERLY TYCO HEALTHCARE 0907002143

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention