BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PORTEX 7.0MM SUCTIONAID TRACHEOSTOMY TUBE

    MDR report key: 1810967 · Received August 9, 2010

    Report

    Report Number
    2183502-2010-00344
    Event Type
    Malfunction
    Date Received
    August 9, 2010
    Report Date
    August 3, 2010
    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

    ADDITIONAL MANUFACTURER NARRATIVE: 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 STATES THAT THE INFLATION LINE DETACHED FROM THE TRACHEOSTOMY TUBE AFTER 7 DAYS IN SITU. THERE WAS NO REPORT OF INCIDENT RELATED MEDICAL SEQUELAE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PORTEX 7.0MM SUCTIONAID TRACHEOSTOMY TUBE TRACHEOSTOMY TUBES JOH SMITHS MEDICAL INTERNATIONAL, LTD. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK