BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUDSON NEBULIZER ADAPTOR 033, STERILE, JAPANESE

    MDR report key: 4114955 · Received September 15, 2014

    Report

    Report Number
    3004365956-2014-00346
    Event Type
    Malfunction
    Date Received
    September 15, 2014
    Date of Event
    August 1, 2014
    Report Date
    August 25, 2014
    Manufacturer
    TELEFLEX
    Product Code
    CCQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    NO VISUAL, FUNCTIONAL AND DIMENSIONAL INSPECTION PERFORMED SINCE THE DEVICE WAS NOT RETURNED. THE DEVICE HISTORY RECORD OF THE PRODUCT WITH LOT #02B1400691 WAS REVIEWED AND WAS FOUND THAT AN NCMR WAS OPENED; (B)(4) REJECTION WAS DUE TO DAMAGE DURING TRANSIT. THE PRODUCT WAS RE-INSPECTED AND RE-PACKED, HOWEVER, THIS TYPE OF DEFECT IS EASILY DETECTED DURING THE MANUFACTURING OF THE PRODUCT SINCE IT IS VERIFIED AT 100%. ADDITIONALLY, PER INTERNAL PROCEDURE, DISTRIBUTION CENTER PERFORMS 100% INSPECTION AS WELL. DHR SHOWS THAT THE PRODUCT WAS PACKED AND INSPECTED ACCORDING TO OUR SPECIFICATIONS. DURING THE INVESTIGATION, IT WAS FOUND THAT COMPONENT TFX-000354 (SHEET FOAM) (B)(4) WAS USED DURING THE MANUFACTURING PROCESS, THIS SHEET FOAM WAS IMPLEMENTED TO PREVENT DAMAGE TO THE PRODUCT. NO CONCLUSION CAN BE ESTABLISHED AT THIS TIME BASED ON THE LACK OF THE DEVICE SAMPLE. IT IS NECESSARY THE PHYSICAL SAMPLE IN ORDER TO PERFORM A PROPER INVESTIGATION. IF THE PRODUCT SAMPLE BECOMES AVAILABLE, THIS COMPLAINT WILL BE REOPENED. THE INVOLVED PRODUCTION AND QUALITY PERSONNEL WERE INFORMED ABOUT THIS COMPLAINT.

    Description of Event or Problem · 1

    THE EVENT IS REPORTED AS: DURING INCOMING INSPECTION BY THE (B)(4)) A PIN HOLE ON PACKAGE IS REPORTED. A TOTAL OF TWENTY-TWO DEVICES WERE REPORTED WITH THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    569283 HUDSON NEBULIZER ADAPTOR 033, STERILE, JAPANESE NEBULIZER ADAPTOR CCQ TELEFLEX 02B1400691

    Patients

    Seq Age Sex Outcome Treatment
    1