BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CIAGLIA BLUE RHINO PERCUTANEOUS TRACHEOSTOMY INTRODUCER

    MDR report key: 2081817 · Received May 5, 2011

    Report

    Report Number
    MW5020497
    Event Type
    Injury
    Date Received
    May 5, 2011
    Date of Event
    April 12, 2011
    Report Date
    April 13, 2011
    Manufacturer
    COOK MEDICAL
    Product Code
    JOH
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT WAS BEING TURNED FOR X-RAY. THE RN NOTICED THE OUTER CANNULA OF THE FRESHLY PLACED TRACH ((B)(6) 2011) COMPLETELY SEPARATED FROM THE PLATE. THIS WAS REPLACED WITH A NEW ONE IN WHICH THE DEFECT OCCURRED AGAIN WITH THE SAME TYPE OF TRACH FROM THE SAME LOT NUMBER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CIAGLIA BLUE RHINO PERCUTANEOUS TRACHEOSTOMY INTRODUCER TRACH JOH COOK MEDICAL 2666167

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention