BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PORTEX BLUE LINE TRACHEOSTOMY TUBE

    MDR report key: 2082524 · Received April 28, 2011

    Report

    Report Number
    2183502-2011-00381
    Event Type
    Malfunction
    Date Received
    April 28, 2011
    Report Date
    April 26, 2011
    Manufacturer
    SMITHS MEDICAL INTERNATIONAL LTD.
    Product Code
    JOH
    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 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 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 TRACHEOSTOMY TUBE TRACHEOSTOMY TUBES JOH SMITHS MEDICAL INTERNATIONAL LTD. NA 1866993

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK