BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUDSON SPIRAL-FLEX ENDOTRACHEAL TUBE, 8.0MM

    MDR report key: 3243095 · Received July 18, 2013

    Report

    Report Number
    3003898360-2013-00303
    Event Type
    Malfunction
    Date Received
    July 18, 2013
    Date of Event
    June 17, 2013
    Report Date
    July 5, 2013
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    BTR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    A VISUAL, FUNCTIONAL AND DIMENSIONAL INSPECTION OF THE PRODUCT INVOLVED IN THE COMPLAINT COULD NOT BE CONDUCTED SINCE THE PRODUCT WAS NOT RETURNED. PER DHR (DEVICE HISTORY RECORD) REVIEW, THE PRODUCT ET TUBE, CUFFED, SPIRAL-FLEX 8.0, LOT #01F1200400, WAS MANUFACTURED ON 07/04/2012. THE DHR INVESTIGATION DID NOT SHOW ISSUES RELATED TO THE COMPLAINT. DOCUMENT (FMEA) ASSESSMENT 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 REPORTS HAVING DIFFICULTY IN DEFLATING THE ENDOTRACHEAL TUBE CUFF. THE ALLEGED ISSUE WAS DETECTED DURING THE PRE-CHECK PRIOR TO PT USE. NO REPORT OF PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    336526 HUDSON SPIRAL-FLEX ENDOTRACHEAL TUBE, 8.0MM ENDOTRACHEAL TUBE BTR TELEFLEX MEDICAL 01F1200400

    Patients

    Seq Age Sex Outcome Treatment
    1