BEUDAMED
    FDA Adverse Event Summary report: N

    CIAGLIA BLUE RHINO TRACHEOSTOMY TUBE

    MDR report key: 2973899 · Received February 13, 2013

    Report

    Report Number
    MW5029033
    Date Received
    February 13, 2013
    Date of Event
    February 8, 2013
    Report Date
    February 13, 2013
    Manufacturer
    COOK MEDICAL INC.
    Product Code
    JOH
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    CIAGLIA BLUE RHINO TRACHEOSTOMY TUBE INSERTED INTO PT TO FIND THAT IT WAS DEFECTIVE AND HAD TO BE CHANGED, THE BALLOON WAS TESTED AND WORKED PROPERLY BUT THE CONNECTION FROM THE OUTER CANNULA TO THE STABILIZER ON TOP WAS LEAKING AIR, NEW SHILEY TRACH INSERTED WITH NO HARM TO PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    64321 CIAGLIA BLUE RHINO TRACHEOSTOMY TUBE TRACH TUBE JOH COOK MEDICAL INC. 3782890

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR