BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PORTEX BLUE LINE SACETT SUCTION ABOVE THE CUFF TRACHEAL TUBE

    MDR report key: 2883449 · Received November 14, 2012

    Report

    Report Number
    2183502-2012-00537
    Event Type
    Malfunction
    Date Received
    November 14, 2012
    Date of Event
    October 4, 2012
    Report Date
    November 8, 2012
    Manufacturer
    SMITHS MEDICAL INTERNATIONAL, LTD
    Product Code
    BTR
    PMA / PMN Number
    K081086
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER HAS NOT YET RETURNED THE DEVICE TO THE MANUFACTURER FOR DEVICE EVAL. WHEN AND IF THE DEVICE BECOMES AVAILABLE AND IS RETURNED AND EVALUATED, THE MANUFACTURER WILL FILE A FOLLOW-UP REPORT DETAILING THE RESULTS OF THE EVAL.

    Description of Event or Problem · 1

    USER FACILITY REPORTED THAT THE DEVICE WAS IN USE WITH PT WHEN OBSTRUCTION OF THE TUBE WAS NOTED. UPON EXAMINATION OF THE TUBE THE REPORTER STATED THAT THE TUBE SHAFT APPEARED TO BE OBSTRUCTED. THE USER FACILITY NOTED THAT THE PRODUCT FELT SOFT TO THE TOUCH AND WAS NECESSARY TO POSITION THE PRODUCT VERTICALLY TO INSURE ADEQUATE PASSAGE. 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 - TRACHEAL TUBES BTR SMITHS MEDICAL INTERNATIONAL, LTD NA 2087579

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK