BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUDSON SHERIDAN/HVT TRACHEAL TUBE

    MDR report key: 2932460 · Received January 24, 2013

    Report

    Report Number
    3003898360-2013-00032
    Event Type
    Malfunction
    Date Received
    January 24, 2013
    Date of Event
    January 1, 2013
    Report Date
    January 9, 2013
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    BTR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    AUDIOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE SAMPLE WAS NOT RECEIVED BY THE MANUFACTURER AT THE TIME OF THIS REPORT. THE COMPLAINT CANNOT BE CONFIRMED SINCE THE SAMPLE WAS NOT AVAILABLE.

    Description of Event or Problem · 1

    THE EVENT IS REPORTED AS: THE CUSTOMER CLAIMS THAT IT WAS DIFFICULT TO INTUBATE ACCURATELY BECAUSE OF THE LOCATION OF THE BLACK RING ON THE ENDOTRACHEAL (ET) TUBE. THE ENDOTRACHEAL TUBE WAS BEING TRIALED WITH THE FACILITY. CUSTOMER STATES THAT THE BLACK RING IS LOCATED IN A DIFFERENT PLACE ON THE ENDOTRACHEAL TUBE COMPARED TO THE TUBES THAT THEY STANDARDLY USE. THE CUSTOMER INDICATES THAT THE TUBE SLIPPED OUT AND THE PT SELF EXTUBATED. THE PT WAS RE-INTUBATED WITHOUT INCIDENT. NO REPORT OF PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    34523 HUDSON SHERIDAN/HVT TRACHEAL TUBE ENDOTRACHEAL TUBE BTR TELEFLEX MEDICAL

    Patients

    Seq Age Sex Outcome Treatment
    1