BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BLUE RHINO TRACHEOSTOMY KIT

    MDR report key: 1267959 · Received December 2, 2008

    Report

    Report Number
    1267959
    Event Type
    Malfunction
    Date Received
    December 2, 2008
    Date of Event
    October 26, 2008
    Report Date
    December 2, 2008
    Manufacturer
    COOK, INC.
    Product Code
    BTO
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TN, US

    Narratives

    Description of Event or Problem · 1

    THE TRACHEOSTOMY TUBE AT THE POINT WHERE THE INNER CANNULA FITS IN BROKE THREE DAYS AFTER INSERTION OF THE DEVICE. THE TRACH WAS REPLACED WITHOUT COMPLICATIONS. THE EXACT LOT NUMBER IS NOT KNOWN, BUT THE FOLLOWING FOUR LOT NUMBERS WERE PRESENT IN THE FACILITY AT THE TIME OF THE EVENT (2097034, 2103336, 2155476 AND 2072520).====================== MANUFACTURER RESPONSE FOR 8 PERC SHILEY TRACH, SHILEY======================MANUFACTURER REPRESENTATIVE CAME TO FACILITY TO EVALUATE DEVICE. THERE IS NOT A DEFINITIVE ANSWER AS TO WHY THIS OCCURRED AT THIS POINT IN TIME. A SIMILAR INCIDENT OCCURRED IN CLOSE PROXIMITY TO THIS EVENT INVOLVING AN 8 DCT SHILEY TRACH THAT IS PART OF THE BLUE RHINO KIT (COOK PRODUCT).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BLUE RHINO TRACHEOSTOMY KIT TUBE, TRACHEOSTOMY BTO COOK, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR NO OTHER THERAPIES| NO OTHER THERAPIES