BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CIAGLIA BLUE RHINO PERCUTANEOUS TRACHEOSTOMY INTRODUCER TRAY

    MDR report key: 1971807 · Received December 3, 2010

    Report

    Report Number
    1820334-2010-00681
    Event Type
    Injury
    Date Received
    December 3, 2010
    Date of Event
    September 23, 2010
    Report Date
    December 3, 2010
    Manufacturer
    COOK, INC.
    Product Code
    DRE
    PMA / PMN Number
    K882796
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). COMMON DEVICE NAME: DQO CATHETER, INTRAVASCULAR, DIAGNOSTIC. EVENT EVAL: STILL UNDER INVESTIGATION.

    Description of Event or Problem · 1

    AS REPORTED TO COOK VIA MEDWATCH REPORT: THE PHYSICIAN PERFORMED A PERCUTANEOUS TRACHEOSTOMY AT THE BEDSIDE IN ICU (INTENSIVE CARE UNIT). APPROX 2CM PORTION OF PLASTIC CATHETER WAS LEFT IN ANTERIOR NECK OF PT. A CT SCAN SHOWED APPROXIMATELY 2CM OF PLASTIC SHEATH, ANTERIOR SUPERIOR AND TO THE RIGHT OF THE TRACHEOSTOMY TUBE ON PT'S SOFT TISSUES OF ANTERIOR NECK. (B)(4) NOTIFIED FOR SURGICAL INTERVENTION OF CATHETER TIP. PT OUTCOME WAS NOT PROVIDED BY REPORTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CIAGLIA BLUE RHINO PERCUTANEOUS TRACHEOSTOMY INTRODUCER TRAY DRE DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION DRE COOK, INC. NA 2551421

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention