BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CIAGLIA BLUE RHINO INTRODUCER TRAY

    MDR report key: 530364 · Received June 18, 2004

    Report

    Report Number
    1820334-2004-00371
    Event Type
    Injury
    Date Received
    June 18, 2004
    Date of Event
    May 24, 2004
    Report Date
    May 24, 2004
    Manufacturer
    COOK, INC.
    Product Code
    KCG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    WHEN ADVANCING THE DILATOR OVER THE WHITE GUIDING CATHETER, IT WENT PAST THE SAFETY RIDGE. THE PHYSICIAN HAD TO CONVERT TO AN OPEN TRACHEOSTOMY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CIAGLIA BLUE RHINO INTRODUCER TRAY SPECIAL SET KCG COOK, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention