BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUDSON OXYGEN SUPPLY TUBING

    MDR report key: 4180376 · Received October 15, 2014

    Report

    Report Number
    3004365956-2014-00374
    Event Type
    Malfunction
    Date Received
    October 15, 2014
    Date of Event
    September 29, 2014
    Report Date
    September 29, 2014
    Manufacturer
    TELEFLEX
    Product Code
    CAI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    A DEVICE HISTORY RECORD (DHR) REVIEW WAS PERFORMED AND THERE WERE NO ISSUES FOUND THAT COULD RELATED TO THE REPORTED COMPLAINT. THE PRODUCT WAS ASSEMBLED AND INSPECTED ACCORDING TO SPECIFICATIONS. THE SAMPLE WAS NOT RETURNED FOR EVALUATION, THEREFORE, THE COMPLAINT COULD NOT BE CONFIRMED. IF THE SAMPLE IS RECEIVED, A FOLLOW-UP REPORT WILL BE SUBMITTED WITH THE INVESTIGATION RESULTS.

    Description of Event or Problem · 1

    THE CUSTOMER IS COMPLAINING THAT WITH THE NEW DESIGN OF THE OXYGEN SUPPLY TUBING, THE CONNECTIONS ARE NOT SECURE TO THE OXYGEN NIPPLE ADAPTOR AND IS FALLING OFF DURING PT USE AT FLOW RATES >5 LPM. THERE WAS NO REPORT OF PT HARM OR INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    655832 HUDSON OXYGEN SUPPLY TUBING OXYGEN SUPPLY TUBING CAI TELEFLEX 02L1302154

    Patients

    Seq Age Sex Outcome Treatment
    1