BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUDSON SPIRAL-FLEX ENDOTRACHEAL TUBE, 7.5MM

    MDR report key: 3193100 · Received June 21, 2013

    Report

    Report Number
    3003898360-2013-00248
    Event Type
    Malfunction
    Date Received
    June 21, 2013
    Date of Event
    May 16, 2013
    Report Date
    June 4, 2013
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    BTR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    A VISUAL, DIMENSIONAL AND FUNCTIONAL INSPECTION COULD NOT BE CONDUCTED SINCE THE PRODUCT WAS NOT RETURNED. A DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED ON THE REPORTED LOT NUMBER. THE DHR INVESTIGATION DID NOT SHOW ISSUES RELATED TO THE COMPLAINT. A DOCUMENT REVIEW - FMEA (PRODUCT/PROCESS) ASSESSMENT WAS CONDUCTED AND NO CHANGES WERE REQUIRED. THE CUSTOMER COMPLAINT CAN NOT 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 THE BALLOON IS LEAKING AT THE UPPER PART OF THE TUBE. THE PATIENT CONDITION IS REPORTED AS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    283002 HUDSON SPIRAL-FLEX ENDOTRACHEAL TUBE, 7.5MM ENDOTRACHEAL TUBE BTR TELEFLEX MEDICAL 01K1100238

    Patients

    Seq Age Sex Outcome Treatment
    1