BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PORTEX BLUE LINE ULTRA CUFFED TRACHEOSTOMY TUBE

    MDR report key: 4232350 · Received October 23, 2014

    Report

    Report Number
    2183502-2014-00792
    Event Type
    Malfunction
    Date Received
    October 23, 2014
    Report Date
    October 23, 2014
    Manufacturer
    SMITHS MEDICAL INTERNATIONAL LTD.
    Product Code
    BTO
    PMA / PMN Number
    K030381
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    RESPIRATORY THERAPIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS CURRENTLY BEING EVALUATED; THE MANUFACTURER 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 LEAKING AT THE CUFF AFTER AN UNKNOWN AMOUNT OF TIME IN SITU. THE TRACHEOSTOMY TUBE WAS REPLACED. NO ADVERSE EFFECTS TO PATIENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    674420 PORTEX BLUE LINE ULTRA CUFFED TRACHEOSTOMY TUBE BTO - TRACHEOSTOMY TUBE KIT BTO SMITHS MEDICAL INTERNATIONAL LTD. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK