BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUDSON NEBULIZER ADAPTOR 033, STERILE, JAPANESE

    MDR report key: 4172813 · Received October 10, 2014

    Report

    Report Number
    3004365956-2014-00368
    Event Type
    Malfunction
    Date Received
    October 10, 2014
    Date of Event
    September 17, 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) FOR LOT#02B1400691 WAS REVIEWED WAS FOUND THAT AN 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 DETECT DURING THE MANUFACTURING OF THE PRODUCT SINCE 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 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 PRODUCT DAMAGE. NO CONCLUSION CAN BE ESTABLISHED AT THIS TIME BASED ON THE LACK OF DEVICE SAMPLE. IT IS NECESSARY TO EVALUATE THE PHYSICAL SAMPLE IN ORDER TO PERFORM A PROPER INVESTIGATION. IF THE PRODUCT SAMPLE BECOMES AVAILABLE THIS COMPLAINT WILL BE RE-OPENED. HOWEVER, 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 HAS BEEN INITIATED. PERSONNEL INVOLVED IN THE MANUFACTURING PROCESS HAVE BEEN NOTIFIED ON THIS ISSUE.

    Description of Event or Problem · 1

    THE EVENT IS REPORTED AS: THE DISTRIBUTOR (B)(4) ALLEGES THAT A PIN HOLE WAS OBSERVED ON THE PACKAGE DURING INCOMING INSPECTION. A TOTAL OF (15) PACKAGES WERE OBSERVED WITH THIS REPORTED ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    642595 HUDSON NEBULIZER ADAPTOR 033, STERILE, JAPANESE NEBULIZER ADAPTOR CCQ TELEFLEX 02B1400691

    Patients

    Seq Age Sex Outcome Treatment
    1