BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SHILEY DISPOSABLE CANNULA LOW PRESSURE

    MDR report key: 1912318 · Received November 11, 2010

    Report

    Report Number
    2936999-2010-01259
    Event Type
    Malfunction
    Date Received
    November 11, 2010
    Date of Event
    October 13, 2010
    Report Date
    October 13, 2010
    Manufacturer
    COVIDIEN/FORMERLY TYCO
    Product Code
    JOH
    PMA / PMN Number
    K962173
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THERE IS NO SAMPLE RETURNING FOR ANALYSIS. THE DEVICE HISTORY RECORD FOR THE LOT NUMBER PROVIDED WAS REVIEWED, (B)(4) AND THERE WAS NO NON-CONFORMING PRODUCT.

    Description of Event or Problem · 1

    INFO RECEIVED ON (B)(6) 2010 ON MAUDE EVENT REPORT (B)(4) CONTAINED THE FOLLOWING: EVENT DATE: (B)(6) 2010, REPORT DATE: (B)(6) 2010. PRODUCT CODE: TUBE, TRACHEAL (W/WO CONNECTOR); EVENT REPORT TYPE: MALFUNCTION; DEVICE OPERATOR: HEALTH PROFESSIONAL; EVENT DESCRIPTION: (B)(6) 2010: THE RING ON THE TRACH TUBE WHICH HOLDS THE INNER CANNULA BROKE OFF. THE INNER CANNULA CAME OUT OF THE TRACH TUBE. DEVICE AVAILABLE FOR EVAL: NOT INDICATED ON FORM; BRAND: SHILEY; DEVICE TYPE: SHILEY TUBE 8 DCT (TRACH TUBE); LOT: 0911000338.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SHILEY DISPOSABLE CANNULA LOW PRESSURE TRACHEOSTOMY TUBE JOH COVIDIEN/FORMERLY TYCO 0911000338

    Patients

    Seq Age Sex Outcome Treatment
    1