BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PORTEX BLUE LINE ULTRA 8.00MM TRACHEOSTOMY TUBE

    MDR report key: 1841296 · Received September 16, 2010

    Report

    Report Number
    2183502-2010-00392
    Event Type
    Malfunction
    Date Received
    September 16, 2010
    Date of Event
    July 3, 2010
    Report Date
    September 9, 2010
    Manufacturer
    SMITHS MEDICAL INTERNATIONAL, LTD.
    Product Code
    BTO
    PMA / PMN Number
    K030381
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER HAS NOT YET RETURNED THE DEVICE TO THE MANUFACTURER FOR DEVICE EVALUATION. 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 EVALUATION.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT ALLEGES THAT THE TRACHEOSTOMY TUBE WAS DEFLATING AT THE CUFF AFTER MORE THAN ONE HOUR IN SITU. REPLACEMENT WAS REQUIRED. NO INCIDENT RELATED MEDICAL SEQUELAE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PORTEX BLUE LINE ULTRA 8.00MM TRACHEOSTOMY TUBE TRACHEOSTOMY TUBE BTO SMITHS MEDICAL INTERNATIONAL, LTD. NA 1723264

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK