BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RUSCH CRYSTAL TRACHEOSTOMY TUBE - CUFFED 8.0MM

    MDR report key: 1930156 · Received November 22, 2010

    Report

    Report Number
    8040412-2010-00101
    Event Type
    Malfunction
    Date Received
    November 22, 2010
    Date of Event
    October 6, 2010
    Report Date
    October 15, 2010
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    JOH
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT HAS NOT YET BEEN RECEIVED BY MANUFACTURER, THEREFORE, INVESTIGATION REPORT IS INCOMPLETE AT THIS TIME. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    THE EVENT IS REPORTED AS: THE CUFF OF THE ET TUBE DEFLATES WITHIN A FEW HOURS. THE TUBE WAS USED TO ADMINISTER TREATMENT WHEN THE ALLEGED DEFECT OCCURRED. NO INJURIES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RUSCH CRYSTAL TRACHEOSTOMY TUBE - CUFFED 8.0MM TRACHEOSTOMY TUBE JOH TELEFLEX MEDICAL NA 09JE44

    Patients

    Seq Age Sex Outcome Treatment
    1