BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUDSON ET TUBE, CF, 4.0MM

    MDR report key: 3820107 · Received April 1, 2014

    Report

    Report Number
    3003898360-2014-00228
    Event Type
    Malfunction
    Date Received
    April 1, 2014
    Date of Event
    March 14, 2014
    Report Date
    March 27, 2014
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    JOH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    NURSE

    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) THE PRODUCT ET TUBE, CF, 4.0, LOT #01D1300174 WAS MANUFACTURED ON 04/17/2013. THE DHR INVESTIGATION DID NOT SHOW ISSUES RELATED TO COMPLAINT. A DOCUMENT ASSESSMENT WAS CONDUCTED AND NO CHANGES WERE REQUIRED. THE COMPLAIN 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 COMPLAINT.

    Description of Event or Problem · 1

    THE EVENT IS REPORTED AS: THE CUSTOMER ALLEGES THAT THE INCREMENTAL MARKINGS ON THE ENDOTRACHEAL TUBE (4.0MM) ARE NOT ACCURATE. THE REPORTED ISSUE WAS DETECTED PRIOR TO PATIENT USE AND DURING PRE-TESTING. NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    196243 HUDSON ET TUBE, CF, 4.0MM ENDOTRACHEAL TUBE JOH TELEFLEX MEDICAL 01D1300174

    Patients

    Seq Age Sex Outcome Treatment
    1