BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUDSON MASK, MEDIUM CONC, ELONG, ADULT

    MDR report key: 3994413 · Received July 23, 2014

    Report

    Report Number
    3004365956-2014-00260
    Event Type
    Malfunction
    Date Received
    July 23, 2014
    Date of Event
    July 2, 2014
    Report Date
    July 9, 2014
    Manufacturer
    TELEFLEX
    Product Code
    BYG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    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 OR A PICTURE OF THE DEFECT WERE NOT PROVIDED. THE DEVICE HISTORY RECORD WAS REVIEWED AND SHOWED THAT THERE WERE NO ISSUES RELATED TO THE REPORT COMPLAINT ON THE PRODUCT OR ITS COMPONENTS DURING THE MANUFACTURE OF THE MATERIAL. A CORRECTIVE ACTION CANNOT BE APPLIED SINCE IT IS NOT POSSIBLE TO IDENTIFY THE DEFECT REPORTED AND TO INVESTIGATE ITS ROOT CAUSE, IN ORDER TO PERFORM A PROPER INVESTIGATION, IT IS NECESSARY TO EVALUATE THE SAMPLE INVOLVED ON THE INCIDENT. THE CUSTOMER COMPLAINT CANNOT BE CONFIRMED BASED ONLY ON THE INFO PROVIDED, IN ORDER TO PERFORM A PROPER INVESTIGATION IT IS NECESSARY TO EVALUATE THE SAMPLE INVOLVED IN THE INCIDENT. HOWEVER, CURRENT PRODUCTION WAS VERIFIED TO IDENTIFY ANY ISSUE THAT CAN LEAD TO THE REPORTED DEFECT AND NO ISSUES WERE FOUND. IF THE DEVICE SAMPLE BECOMES AVAILABLE THIS INVESTIGATION WILL BE UPDATED WITH THE EVAL RESULTS.

    Description of Event or Problem · 1

    THE EVENT IS REPORTED AS: THE CUSTOMER ALLEGES THAT THE TUBING IS COLLAPSING WHEN IT IS ON THE PT. NO REPORT OF A PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    431785 HUDSON MASK, MEDIUM CONC, ELONG, ADULT OXYGEN MASK BYG TELEFLEX 02D1302188

    Patients

    Seq Age Sex Outcome Treatment
    1