BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PORTEX 7.0MM SUCTIONAID TRACHEOSTOMY TUBE

    MDR report key: 1960766 · Received December 17, 2010

    Report

    Report Number
    2183502-2010-00592
    Event Type
    Malfunction
    Date Received
    December 17, 2010
    Date of Event
    November 20, 2010
    Report Date
    December 16, 2010
    Manufacturer
    SMITHS MEDICAL INTERNATIONAL LTD.
    Product Code
    BTO
    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 ALLEGES THAT THE TRACHEOSTOMY TUBE WAS DEFLATING AT THE CUFF AFTER 2 DAYS 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 7.0MM SUCTIONAID TRACHEOSTOMY TUBE TRACHEOSTOMY TUBES BTO SMITHS MEDICAL INTERNATIONAL LTD. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK