BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUDSON NEBULIZER ADAPTOR 033, STERILE, JAPANESE

    MDR report key: 4208914 · Received October 23, 2014

    Report

    Report Number
    3004365956-2014-00377
    Event Type
    Malfunction
    Date Received
    October 23, 2014
    Date of Event
    October 2, 2014
    Report Date
    October 7, 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

    PICTURE RECEIVED WITH THE CUSTOMER COMPLAINT FILE WAS THOROUGHLY REVIEWED. THE SAMPLE PRESENTED AN OPEN SEAL ON PACKAGE. NO FUNCTIONAL INSPECTION CAN BE PERFORMED SINCE THE DEVICE SAMPLE WAS NOT AVAILABLE FOR EVALUATION. THE DEVICE HISTORY RECORD WITH LOT # 74D1400275 HAS BEEN REVIEWED AND NO ISSUES OR DISCREPANCIES WERE FOUND WHICH COULD POTENTIALLY RELATE TO THIS COMPLAINT. NO NON-CONFORMANCE REPORTS WERE ORIGINATED FOR THE LOT IN QUESTION THAT CAN BE ASSOCIATED TO THE COMPLAINT REPORTED. THE DHR (DEVICE HISTORY RECORD) SHOWS THAT THE PRODUCT WAS PACKED AND INSPECTED ACCORDING TO OUR SPECIFICATIONS. DURING THE INVESTIGATION IT WAS FOUND THAT COMPONENT TFX-000354 (SHEET FOAM) BATCH (B)(4) WAS USED DURING THE MANUFACTURING PROCESS, THIS SHEET FOAM WAS IMPLEMENTED TO PREVENT THE PRODUCT FROM DAMAGE. THIS TYPE OF DEFECT IS EASY TO BE DETECTED DURING THE MANUFACTURING OF THE PRODUCT SINCE IS VERIFIED AT 100%. ADDITIONALLY, PER INTERNAL PROCEDURE, DISTRIBUTION CENTER PERFORMS 100% INSPECTION AS WELL. BASED ON THE PICTURE PROVIDED, THE CUSTOMER COMPLAINT IS CONFIRMED. AS A CORRECTIVE ACTION A NEW PACKAGING METHOD WILL BE IMPLEMENTED IN ORDER TO AVOID OPEN SEAL IN THE PRODUCT. "R & D" HAS INITIATED THIS PROJECT. THE INVOLVED PRODUCTION AND QUALITY PERSONNEL WERE INFORMED ABOUT THIS COMPLAINT.

    Description of Event or Problem · 1

    THE EVENT IS REPORTED AS: THE DISTRIBUTOR (IMJ) ALLEGES THAT DURING INCOMING INSPECTION THE PACKAGE WAS FOUND TO HAVE A "FAULTY SEALING." A TOTAL OF 230 PACKAGES WERE REPORTED FOR THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    675665 HUDSON NEBULIZER ADAPTOR 033, STERILE, JAPANESE NEBULIZER ADAPTOR CCQ TELEFLEX 74D1400275

    Patients

    Seq Age Sex Outcome Treatment
    1