BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUDSON NEBULIZER ADAPTOR 033, STERILE, JAPANESE

    MDR report key: 4172793 · Received October 10, 2014

    Report

    Report Number
    3004365956-2014-00362
    Event Type
    Malfunction
    Date Received
    October 10, 2014
    Date of Event
    September 25, 2014
    Report Date
    September 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 OR FUNCTIONAL INSPECTION CAN BE PERFORMED SINCE THE DEVICE SAMPLE IS NOT AVAILABLE FOR EVALUATION. THE DEVICE HISTORY RECORD (DHR) OF THE PRODUCT 031-33J WITH BATCH NUMBER (B)(4) HAS BEEN REVIEWED AND WAS FOUND THAT THE NCMR WAS OPENED; FOR DAMAGE DURING TRANSIT. COMPLETE LOT WAS INSPECTED 100% VISUAL INSPECTION. THE PRODUCT WAS RE-INSPECTED AND RE-PACKED HOWEVER THIS TYPE OF DEFECT IS EASY TO DETECTED DURING THE MANUFACTURING OF THE PRODUCT SINCE IS VERIFIED AT 100%. ADDITIONALLY, PER INTERNAL PROCEDURE, DISTRIBUTION CENTER PERFORMS 100% INSPECTION AS WELL. ADDITIONALLY 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) BATCH (B)(4) WAS USED DURING THE MANUFACTURING PROCESS, THIS SHEET FOAM WAS IMPLEMENTED TO PREVENT THE PRODUCT FROM DAMAGE. NO CONCLUSION CAN BE ESTABLISHED AT THIS TIME BASED ON THE LACK OF DEVICE SAMPLE. IF THE PRODUCT SAMPLE BECOMES AVAILABLE THIS COMPLAINT WILL BE RE-OPENED. MANUFACTURING AND R&D DEPARTMENTS ARE EVALUATING THE CURRENT PACKAGING DESIGN, A PROPOSAL OF A NEW PACKAGING METHOD HAS BEEN IDENTIFIED, AND THEREFORE A PROCESS/DESIGN VALIDATION HAS BEEN INITIATED. PERSONNEL INVOLVED ON THE MANUFACTURING PROCESS WERE NOTIFIED.

    Description of Event or Problem · 1

    THE EVENT IS REPORTED AS: THE DISTRIBUTOR (IMJ) ALLEGES THAT A BROKEN PACKAGE WAS OBSERVED DURING INCOMING INSPECTION. A TOTAL OF FOUR (4) PACKAGES WERE OBSERVED WITH THIS REPORTED ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    642859 HUDSON NEBULIZER ADAPTOR 033, STERILE, JAPANESE NEBULIZER ADAPTOR CCQ TELEFLEX 02B1400691

    Patients

    Seq Age Sex Outcome Treatment
    1