BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUDSON SHERIDAN/CF MAGILL TRACHEAL TUBE, 9.0MM

    MDR report key: 3243091 · Received July 18, 2013

    Report

    Report Number
    3003898360-2013-00316
    Event Type
    Malfunction
    Date Received
    July 18, 2013
    Date of Event
    July 1, 2013
    Report Date
    July 4, 2013
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    BTR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    A VISUAL, DIMENSIONAL AND FUNCTIONAL INSPECTION OF THE PRODUCT INVOLVED IN THE COMPLAINT COULD NOT BE CONDUCTED SINCE THE PRODUCT WAS NOT RETURNED. A DHR (DEVICE HISTORY RECORD) REVIEW COULD NOT BE CONDUCTED SINCE THE LOT NUMBER WAS NOT PROVIDED. A DOCUMENT ASSESSMENT (FMEA) WAS CONDUCTED AND NO CHANGES WERE REQUIRED. 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 FOR IT. TELEFLEX WILL CONTINUE TO MONITOR AND TREND RELATING COMPLAINTS.

    Description of Event or Problem · 1

    THE EVENT IS REPORTED AS: THE CUSTOMER ALLEGES THAT ON TRANSFERRING A PT TO THE INTENSIVE CARE UNIT, THE TUBE BECAME SOFT AND KINKED. THE PT WAS RE-INTUBATED. NO REPORT OF A PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    335556 HUDSON SHERIDAN/CF MAGILL TRACHEAL TUBE, 9.0MM ENDOTRACHEAL TUBE BTR TELEFLEX MEDICAL

    Patients

    Seq Age Sex Outcome Treatment
    1