BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUDSON SHERIDAN/HVT TRACHEAL TUBE, 7.5

    MDR report key: 2900835 · Received December 12, 2012

    Report

    Report Number
    3003898360-2012-00587
    Event Type
    Malfunction
    Date Received
    December 12, 2012
    Date of Event
    November 28, 2012
    Report Date
    November 29, 2012
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    BTR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    A DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED ON THE REPORTED LOT NUMBER. THE DHR INVESTIGATION DID NOT SHOW ISSUES RELATED TO THE COMPLAINT. THE COMPLAINT CANNOT BE CONFIRMED SINCE THE SAMPLE WAS NOT AVAILABLE FOR THE INVESTIGATION, HOWEVER, TELEFLEX WILL CONTINUE TO MONITOR AND TREND RELATING COMPLAINTS.

    Description of Event or Problem · 1

    THE EVENT IS REPORTED AS: THE COMPLAINT ALLEGES THAT THERE IS DIFFICULTY DEFLATING AND INFLATING THE CUFF OF THE ET TUBE. COMPLAINT INDICATES THAT THE TUBE HAD TO BE DEFLATED SEVERAL TIMES TO ASSURE THAT THE CUFF WAS FULLY DEFLATED. NO REPORT OF PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HUDSON SHERIDAN/HVT TRACHEAL TUBE, 7.5 ENDOTRACHEAL TUBE BTR TELEFLEX MEDICAL 01G1200069

    Patients

    Seq Age Sex Outcome Treatment
    1