BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUDSON NEBULIZER ADAPTOR 028, STERILE, SHELFPAK

    MDR report key: 4172810 · Received October 10, 2014

    Report

    Report Number
    3004365956-2014-00367
    Event Type
    Malfunction
    Date Received
    October 10, 2014
    Date of Event
    September 17, 2014
    Report Date
    September 25, 2014
    Manufacturer
    TELEFLEX MEDICAL
    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 (B)(4) WITH BATCH NUMBER (B)(4) WAS 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 SHOWS THAT THE PRODUCT WAS ASSEMBLED AND INSPECTED ACCORDING TO OUR SPECIFICATIONS. DURING THE INVESTIGATION IT WAS FOUND THAT COMPONENT TFX-000354 (SHEET FOAM) BATCH (B)(4) AND (B)(4) WERE USED DURING THE MANUFACTURING PROCESS, TO PREVENT PRODUCT DAMAGE. ADDITIONALLY, PER INTERNAL PROCEDURE, DISTRIBUTION CENTER PERFORMS 100% INSPECTION AS WELL AS 100% INSPECTION DURING MANUFACTURING. 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 VALIDATION HAS BEEN INITIATED. PERSONNEL INVOLVED ON 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 (10) PACKAGES WERE OBSERVED WITH THIS REPORTED ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    642594 HUDSON NEBULIZER ADAPTOR 028, STERILE, SHELFPAK NEBULIZER ADAPTOR CCQ TELEFLEX MEDICAL 02C1402447

    Patients

    Seq Age Sex Outcome Treatment
    1