BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CIAGLIA BLUE DOLPHIN PERCUTANEOUS TRACHEOSTOMY INTRODUCER SET

    MDR report key: 1881086 · Received October 20, 2010

    Report

    Report Number
    1820334-2010-00511
    Event Type
    Injury
    Date Received
    October 20, 2010
    Date of Event
    September 20, 2010
    Report Date
    September 20, 2010
    Manufacturer
    COOK INC.
    Product Code
    JOH
    PMA / PMN Number
    K072148
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    WHILE THE PHYSICIAN TRIED TO INFLATE THE BALLOON A SECOND TIME (AFTER ONE FAILED INSERTION OF THE TRACHEOSTOMY TUBE), THE BALLOON BURST AT A PRESSURE OF 11 ATM, WHILE STILL INSIDE THE PATIENT. THE PHYSICIAN LEFT THE WIRE GUIDE INSIDE THE PATIENT, USED A NEW BLUE RHINO SET TO INSERT A TRACHEOSTOMY CANNULA AND PLACED IT. THE PHYSICIAN THEN REMOVED THE SMALL PIECES FROM THE BALLOON VIA A BRONCHOSCOPY FROM THE TRACHEA OF THE PATIENT. PATIENT OUTCOME WAS NOT PROVIDED BY REPORTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CIAGLIA BLUE DOLPHIN PERCUTANEOUS TRACHEOSTOMY INTRODUCER SET JOH TUBE TRACHEOSTOMY AND TUBE CUFF JOH COOK INC. NA F2462299

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention