BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PORTEX BLUE LINE CUFFED ADJUSTABLE FLANGE TRACHEOSTOMY TUBES

    MDR report key: 1920690 · Received December 6, 2010

    Report

    Report Number
    2183502-2010-00570
    Event Type
    Malfunction
    Date Received
    December 6, 2010
    Date of Event
    November 1, 2011
    Report Date
    December 3, 2010
    Manufacturer
    SMITHS MEDICAL INTERNATIONAL, LTD
    Product Code
    JOH
    PMA / PMN Number
    K962175
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    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 FOLLOW-UP REPORT DETAILING THE RESULTS OF THE EVAL.

    Description of Event or Problem · 1

    USER FACILITY REPORTED THAT THE PRODUCT WAS IN USE WITH PT. THE PRODUCT WAS FOUND TO BE LEAKING AND THE LEAKAGE SOURCE WAS CONFIRMED TO BE THE INFLATION LINE. USER REPORTED THE DEVICE REMOVED AND REPLACED. NO INCIDENT RELATED MEDICAL SEQUELA REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PORTEX BLUE LINE CUFFED ADJUSTABLE FLANGE TRACHEOSTOMY TUBES TRACHEOSTOMY TUBE JOH SMITHS MEDICAL INTERNATIONAL, LTD NA 1549180

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK