BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PORTEX BLUE LINE SACETT SUCTION ABOVE THE CUFF TRACHEAL TUBE

    MDR report key: 2070308 · Received April 18, 2011

    Report

    Report Number
    2183502-2011-00154
    Event Type
    Injury
    Date Received
    April 18, 2011
    Report Date
    April 12, 2011
    Manufacturer
    SMITHS MEDICAL MD, INC.
    Product Code
    BTR
    PMA / PMN Number
    K081086
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER HAS NOT YET RETURNED THE DEVICE TO THE MFR FOR DEVICE EVAL. WHEN AND IF THE DEVICE BECOMES AVAILABLE AND IS RETURNED AND EVALUATED THE MFR WILL FILE A F/U REPORT DETAILING THE RESULTS OF THE EVAL.

    Description of Event or Problem · 1

    USER FACILITY REPORTED THAT DURING THE PT FIO2 BECAME LOW. THE PHYSICIAN NOTICED THAT THE TUBE WAS BENT AND UNABLE TO SUPPORT THE WEIGHT OF THE VENT TUBING, PREVENTING ACCEPTABLE VENTILATION. THE TUBING WAS ADJUSTED AND VENTILATION IMPROVED. NO PERMANENT ADVERSE EFFECTS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PORTEX BLUE LINE SACETT SUCTION ABOVE THE CUFF TRACHEAL TUBE BTR SMITHS MEDICAL MD, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention