BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CIAGLIA BLUE RHINO PERCUTANEOUS TRACHEOSTOMY INTRODUCER SET

    MDR report key: 3818090 · Received May 12, 2014

    Report

    Report Number
    1820334-2014-00215
    Event Type
    Injury
    Date Received
    May 12, 2014
    Date of Event
    April 25, 2014
    Report Date
    April 25, 2014
    Manufacturer
    COOK, INC.
    Product Code
    KCG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVENT IS STILL UNDER INVESTIGATION.

    Description of Event or Problem · 1

    A (B)(6) FEMALE PATIENT UNDERWENT TRACHEOSTOMY TUBE PLACEMENT ON (B)(6) 2014. AFTER INITIAL DILATION WITH SMALL DILATOR, THE USER EXCHANGED FOR A BLUE RHINO WITH WHITE STYLET. UPON ADVANCEMENT, IT WAS NOTED THAT THE WIRE AND STYLET WERE BEING SEEN SIDE BY SIDE, WHICH IS NOT SUPPOSED TO HAPPEN. STYLET WAS PULLED BACK AND IT WAS NOTED OT BE UNDERNEATH POSTERIOR WALL OF THE TRACHEA RATHER THAN INTRALUMINAL. IT IS UNCLEAR AS TO WHEN THE STYLET PERFORATED THE POSTERIOR TRACHEA WALL. PATIENT IS STABLE, AND SCHEDULED FOR SURGERY WITHIN THE NEXT 1-2 DAYS. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECT DUE TO THIS OCCURENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    283288 CIAGLIA BLUE RHINO PERCUTANEOUS TRACHEOSTOMY INTRODUCER SET KCG DILATOR, TRACHEAL KCG COOK, INC. NA 4784987

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Required Intervention