BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNK

    MDR report key: 3061339 · Received April 10, 2013

    Report

    Report Number
    3003898360-2013-00137
    Event Type
    Malfunction
    Date Received
    April 10, 2013
    Date of Event
    March 1, 2013
    Report Date
    March 15, 2013
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    BTR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A VISUAL, DIMENSIONAL AND FUNCTIONAL INSPECTION COULD NOT BE CONDUCTED SINCE THE PRODUCT WAS NOT RETURNED. A COMPLAINT HISTORY REVIEW FOR THE CATALOG NUMBER COULD NOT BE CONDUCTED SINCE THE CATALOG NUMBER WAS NOT PROVIDED. A DEVICE HISTORY RECORD REVIEW COULD NOT BE CONDUCTED SINCE THE LOT NUMBER WAS NOT PROVIDED. THE COMPLAINT CANNOT BE CONFIRMED SINCE THE SAMPLE WAS NOT AVAILABLE FOR INVESTIGATION; THEREFORE, IT IS NOT POSSIBLE TO DETERMINE THE ROOT CAUSE FOR THE DEFECT REPORTED AND A CORRECTIVE ACTION TAKEN. TELEFLEX WILL CONTINUE TO MONITOR AND TREND RELATING COMPLAINTS.

    Description of Event or Problem · 1

    THE EVENT IS REPORTED AS: THE CUSTOMER REPORTS THAT THE RESPIRATORY THERAPIST ATTACHED A STOPCOCK TO THE ONE WAY VALVE IN ORDER TO KEEP THE PRESSURE IN THE CUFF OF AN ENDOTRACHEAL TUBE. THE PT WAS STILL USING THE PRODUCT AT THE TIME THIS EVENT WAS REPORTED. NO REPORT OF A PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    150171 UNK ENDOTRACHEAL TUBE BTR TELEFLEX MEDICAL UNK

    Patients

    Seq Age Sex Outcome Treatment
    1