BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PORTEX BLUE LINE ULTRA TRACHEOSTOMY TUBE

    MDR report key: 2881232 · Received November 14, 2012

    Report

    Report Number
    2183502-2012-00552
    Event Type
    Malfunction
    Date Received
    November 14, 2012
    Report Date
    November 13, 2012
    Manufacturer
    SMITHS MEDICAL INTERNATIONAL LTD.
    Product Code
    BTO
    PMA / PMN Number
    K030381
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    UNKNOWN

    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

    A REPORT WAS REC'D THAT ALLEGES THAT DURING CHECK OF THE CANNULA, DAMAGE WAS OBSERVED ON THE CUFF AFTER AN UNK AMOUNT OF TIME IN SITU. REPLACEMENT WAS REQUIRED. NO INCIDENT RELATED MEDICAL SEQUELA WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PORTEX BLUE LINE ULTRA TRACHEOSTOMY TUBE BTO - TUBE, TRACHEOSTOMY (W/WO CONNECTOR) BTO SMITHS MEDICAL INTERNATIONAL LTD. NA 2199944

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK