BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUDSON NEBULIZER ADAPTOR 033, STERILE

    MDR report key: 3301058 · Received August 15, 2013

    Report

    Report Number
    3004365956-2013-00268
    Event Type
    Malfunction
    Date Received
    August 15, 2013
    Date of Event
    June 19, 2013
    Report Date
    July 31, 2013
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    CAF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NOT APPLICABLE
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    ONE PICTURE OF THE UNIT OF CATALOG NUMBER 031-33J (NEBULIZER ADAPTOR 033, STERILE, JAPANESE) WAS REC'D FOR ANALYSIS. IT WAS VISUALLY INSPECTED AND IT WAS NOTED THAT THE YELLOW WINGNUT (P/N MP-0318) WAS BROKEN. A DIMENSIONAL AND FUNCTIONAL INSPECTION REPORT WAS NOT REQUIRED SINCE THE DEFECT REPORTED IS NOT RELATED TO A DIMENSIONAL ISSUE. THE PART NUMBER 12153 IS A COMPONENT OF THE PART NUMBER 031-33J. FOR THAT REASON THE 12153 ASSEMBLY PROCESS AND MANUFACTURING PROCEDURE WERE REVIEWED AND NO FINDINGS THAT CAN POTENTIALLY RELATE TO THE REPORTED ISSUE WERE FOUND. THE YELLOW WINGNUT (P/N MP-0318) IS PROCESSED THROUGH OUR INTERNAL PROCESS OF MOLDING, THE MOLDING PROCESS WAS REVIEWED AND NO FINDINGS THAT CAN POTENTIALLY RELATE TO THE REPORTED ISSUE WERE FOUND. A DHR (DEVICE HISTORY RECORD) REVIEW COULD NOT BE CONDUCTED SINCE THE LOT NUMBER WAS NOT PROVIDED. THE CUSTOMER COMPLAINT WAS CONFIRMED BASED ON THE PICTURE REC'D. THE CRACK OBSERVED ON THE PICTURE REC'D COULD NOT BE GENERATED BY OUR PROCESS. THE CUSTOMER COMPLAINT WAS CONFIRMED BASED ON THE PICTURE REC'D. ACCORDING WITH THE COMPLAINT DESCRIPTION (THE CONNECTOR WAS BROKEN WHILE THE USER WAS TRYING TO CHANGE THE DIRECTION OF THE CONNECTOR) AND SINCE NO ISSUES WERE FOUND IN THE ASSEMBLY AND MOLDING PROCESS, THE ROOT CAUSE COULD BE RELATED WITH THE METHOD OF USE, THEREFORE NO CORRECTIVE ACTION CAN BE PROVIDED.

    Description of Event or Problem · 1

    THE COMPLAINT WAS REPORTED AS: THE CUSTOMER ALLEGES THAT THE CONNECTOR WAS BROKEN WHILE THE USER WAS TRYING TO CHANGE DIRECTION OF THE CONNECTOR. NO REPORT OF A PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    111434 HUDSON NEBULIZER ADAPTOR 033, STERILE LARGE VOLUME NEBULIZER CAF TELEFLEX MEDICAL

    Patients

    Seq Age Sex Outcome Treatment
    1