BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PORTEX ULTRAPERC SINGLE DILATOR TECHNIQUE KITS

    MDR report key: 4102651 · Received September 10, 2014

    Report

    Report Number
    2183502-2014-00660
    Event Type
    Injury
    Date Received
    September 10, 2014
    Report Date
    September 9, 2014
    Manufacturer
    SMITHS MEDICAL INTERNATIONAL LTD.
    Product Code
    JOH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    SMITHS MEDICAL HAS RECEIVED THE SAMPLE DEVICE. A FULL EVALUATION IS ANTICIPATED, BUT NOT YET BEGUN AS THE DEVICE IS CURRENTLY IN TRANSIT TO THE INVESTIGATION SITE. SMITHS MEDICAL WILL FILE A FOLLOW-UP REPORT DETAILING THE RESULTS OF THE EVALUATION ONCE IT IS COMPLETED.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT THE LISTED DEVICE WAS INSERTED INTO THE PATIENT. WHEN THE SINGLE STAGE DILATOR WAS RETRACTED FROM THE PATIENT'S TRACHEA, PARTICLES OF LUBRICIOUS COATING (A COATING COVERING THE DILATOR THAT AIDS IN A SMOOTH INSERTION/REMOVAL OF THE DILATOR DEVICE) WERE OBSERVED REMAINING IN THE PATIENT'S TRACHEA. THE DOCTOR EXTRACTED THE PARTICLES FROM THE PATIENT. NO PERMANENT ADVERSE EFFECTS TO THE PATIENT WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    559508 PORTEX ULTRAPERC SINGLE DILATOR TECHNIQUE KITS JOH - TRACHEOSTOMY TUBE JOH SMITHS MEDICAL INTERNATIONAL LTD. NA 2613377

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention