BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CIAGLIA BLUE RHINO G2

    MDR report key: 8306682 · Received December 17, 2018

    Report

    Report Number
    8306682
    Event Type
    Malfunction
    Date Received
    December 17, 2018
    Date of Event
    November 30, 2018
    Report Date
    December 13, 2018
    Manufacturer
    COOK MEDICAL LL
    Product Code
    KCG
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2018 ATTEMPTED PERCUTANEOUS TRACH AT BEDSIDE. THE WHITE GUIDEWIRE SLID PAST THE NOTCH WHILE ATTEMPTING DILATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1012095 CIAGLIA BLUE RHINO G2 TRACHOSTOMY KIT KCG COOK MEDICAL LL 8915391

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Other