BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUDSON CORR-A-FLES TUBING, 100 FT ROLL

    MDR report key: 3813232 · Received March 31, 2014

    Report

    Report Number
    3004365956-2014-00160
    Event Type
    Malfunction
    Date Received
    March 31, 2014
    Date of Event
    March 7, 2014
    Report Date
    March 19, 2014
    Manufacturer
    TELEFLEX
    Product Code
    BZO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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. THE DEVICE HISTORY RECORD (DHR) FOR THE REPORTED LOT NUMBER WAS REVIEWED AND NO ISSUES OR DISCREPANCIES WERE FOUND WHICH COULD POTENTIALLY BE RELATED TO THIS COMPLAINT. ANY NON CONFORMANCE REPORTS WERE ORIGINATED FOR THE LOT IN QUESTION THAT CAN BE ASSOCIATED TO THE COMPLAINT REPORTED. THE DHR SHOW THAT THE PRODUCT WAS ASSEMBLED AND INSPECTED ACCORDING TO OUR SPECIFICATIONS. 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 IN THE INCIDENT. CUSTOMER COMPLAINT CANNOT BE CONFIRMED BASED ONLY ON THE INFORMATION PROVIDED. HOWEVER CURRENT PRODUCTION WAS VERIFIED TO IDENTIFY ANY ISSUE THAT CAN LEAD TO THE REPORTED DEFECT AND NO ISSUES WERE FOUND SINCE WALL THICKNESS AND INTERNAL DIAMETER WERE FOUND WITHIN SPECIFICATION, ALSO A LEAKING TEST WAS PERFORMED ON THESE SAMPLES ON FIXTURE (TF-0138 / NLC03389 DUE DATE MARCH 07, 2014) IN ORDER TO VERIFY THE FUNCTIONALITY ON THE CONNECTIONS AND NO PROBLEMS WERE PRESENTED DURING THE PERFORMED VERIFICATION. IF THE DEFECTIVE SAMPLE BECOMES AVAILABLE THIS INVESTIGATION WILL BE UPDATED WITH THE EVALUATION RESULTS. AS A CORRECTIVE ACTION R&D ENGINEERING DEPARTMENT WILL BE NOTIFIED ABOUT THE COMPLAINT RECEIVED. SINCE THE LOT MENTIONED ON THIS CUSTOMER COMPLAINT IS RELATED TO A RESIN CHANGE PROJECT PERFORMED IN (B)(4) 2013.

    Description of Event or Problem · 1

    THE EVENT IS REPORTED AS: THE CUSTOMER ALLEGES THAT THE END OF THE TUBING WILL NOT STAY IN PLACE AND POPS OFF. ALSO, WHEN ATTACHING THE TUBING TO THE AEROSOL MASK, THE MASK DOES NOT FIT PROPERLY TO THE PATIENT'S FACE BECAUSE THE TUBING TORQUES. NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    189911 HUDSON CORR-A-FLES TUBING, 100 FT ROLL OXYGEN TUBING BZO TELEFLEX 02M1301014

    Patients

    Seq Age Sex Outcome Treatment
    1