BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PORTEX BLUE LINE ULTRA SUCTIONAID TRACHEOSTOMY TUBE KIT

    MDR report key: 4032061 · Received August 5, 2014

    Report

    Report Number
    2183502-2014-00556
    Event Type
    Malfunction
    Date Received
    August 5, 2014
    Date of Event
    July 14, 2014
    Report Date
    August 4, 2014
    Manufacturer
    SMITHS MEDICAL INTERNATIONAL LTD.
    Product Code
    BTO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER

    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

    A REPORT WAS RECEIVED STATING THAT THE TRACHEOSTOMY TUBE WAS DEFLATING AT THE CUFF AFTER AN UNKNOWN AMOUNT OF TIME IN SITU. THE TRACHEOSTOMY TUBE WAS REPLACED. THE USER REPORTED THAT THE CUFF WAS FOUND RUPTURED ON THE REMOVED DEVICE. NO ADVERSE EFFECTS TO PATIENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    455956 PORTEX BLUE LINE ULTRA SUCTIONAID TRACHEOSTOMY TUBE KIT BTO - TRACHEOSTOMY TUBE KIT BTO SMITHS MEDICAL INTERNATIONAL LTD. NA 2491832

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK