BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PORTEX SOFT SEA LCUFF TRACHEAL TUBE

    MDR report key: 3901511 · Received June 20, 2014

    Report

    Report Number
    2183502-2014-00426
    Event Type
    Injury
    Date Received
    June 20, 2014
    Date of Event
    April 23, 2014
    Report Date
    June 20, 2014
    Manufacturer
    SMITHS MEDICAL INTERNATIONAL LTD
    Product Code
    BTR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS CURRENTLY BEING EVALUATED; THE MFR WILL FILE A FOLLOW UP REPORT DETAILING THE RESULTS OF THE EVAL ONCE IT IS COMPLETED.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT THE DEVICE WAS IN USE WITH A PT WITH CHEST INFECTION/ EMPYEMA ON HIGH FREQUENCY OSCILLARY VENTILATION. HIGH CO2 LEVELS AND RESPIRATORY ACIDOSIS WERE OBSERVED AFTER THE TUBE HAD BEEN IN SITU FOR UNK AMOUNT OF TIME. THE USER FACILITY WAS UNABLE TO PASS A SUCTION CATHETER PAST 14 CM DUE TO A KINK IN THE TUBE AT THE BACK OF THE PT'S MOUTH OBSERVED BY LARYNGOSCOPY. AFTER THE TUBE WAS STRAIGHTENED, PT'S CO2 LEVELS IMPROVED. THE DEVICE WAS SUBSEQUENTLY REPLACED; AFTER REMOVAL OF THE DEVICE, THE USER FACILITY OBSERVED A SLIGHT INDENTATION IN THE TUBING. NO PERMANENT ADVERSE EFFECTS TO THE PT WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    363205 PORTEX SOFT SEA LCUFF TRACHEAL TUBE ENDOTRACHEAL TUBE, SINGLE-USE BTR SMITHS MEDICAL INTERNATIONAL LTD NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention