BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPTI-MIST PLUS MASK KIT

    MDR report key: 4886632 · Received July 1, 2015

    Report

    Report Number
    9680866-2015-00040
    Event Type
    Malfunction
    Date Received
    July 1, 2015
    Report Date
    June 18, 2015
    Manufacturer
    UNOMEDICAL S.A. DE C.V.
    Product Code
    CAF
    PMA / PMN Number
    K791536
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE AVAILABLE INFORMATION, THIS EVENT IS DEEMED A REPORTABLE MALFUNCTION. NO FURTHER INFORMATION WAS AVAILABLE AT THE TIME OF THE REPORT. THIS COMPLAINT INVOLVES AN UNKNOWN NUMBER OF DEVICES. ADDITIONAL PATIENT/EVENT DETAILS HAVE BEEN REQUESTED. THERE WERE NO REPORTS OF THE PATIENT BEING HARMED AS A RESULT OF THIS MALFUNCTION. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    PREVIOUS INVESTIGATION LEVERAGED FOR THIS COMPLAIN AND THE INVESTIGATION IS COMPLETED. TWO ROOT CAUSES WERE IDENTIFIED. THE JET WAS BEING PRODUCED IN AN OLD INJECTION MOLDING MACHINE THAT WAS NOT CONDITIONED WITH AN ALARM TO DETECT AND PREVENT THE VARIATION (DOUBLE CYCLE) IN THE PROCESS. THIS MACHINE HAS BEEN DISCONTINUED. INADEQUATE INSPECTION PROCESS FOR NEBULIZERS. CORRECTIVE ACTION HAS BEEN IMPLEMENTED TO INCLUDE: VERIFYING ALL ACTIVE MOLDING MACHINES TO CONFIRM ALL HAVE INTEGRATED THE REQUIRED ALARMS. CREATE A TEMPORARY QUALITY ALERT TO INSPECT NEBULIZER COMPONENTS EVERY 2 HOURS AS OUR INSPECTION PROCESS IS UPDATED. CREATION OF A TEST METHOD FOR INSPECTION OF MOLDED COMPONENTS (NEBULIZER SET AND JET). CREATE A TEST METHOD FOR INSPECTION OF MOLDED COMPONENTS, CLARIFY ALL DETAILS OF PROCESS TO DO THE MIXING AND ADD A FORM TO RECORD THE AMOUNT OF RESIN AND MATERIAL USED IN EACH MIXING, DETERMINE WATER FLOW RATES, WATER TEMPERATURE AND PRESSURE, AND INCLUDE PROCESS PARAMETERS TO BE MONITORED. DETERMINED THE EXPECTED SHELF LIFE OF PINS FOR THE ORIFICE OF CUP AND JET, AND ESTABLISH ITS REPLACEMENT IN THE ADEQUATE PERIOD OF TIME. NO ADDITIONAL PATIENT/EVENT DETAILS HAVE BEEN PROVIDED TO DATE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE A FOLLOW-UP REPORT WILL BE SUBMITTED. (B)(4)

    Additional Manufacturer Narrative · 1

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED AS THE RESULTS OF THE INVESTIGATION INDICATED THAT THE POSSIBLE PRODUCT AFFECTED BY NON CONFORMITY UNDER THIS INVESTIGATION WAS PRODUCED IN AN OLD INJECTION MACHINE WHICH HAD NOT THE TECHNOLOGY TO DETECT AND PREVENT A FAILURE LIKE A DOUBLE CYCLE. A CORRECTIVE ACTION WAS INITIATED TO ADDRESS THE MANUFACTURING QUALITY INCONSISTENCIES AND ADDITIONAL TRAINING INITIATIVES WERE IMPLEMENTED FOR THE OPERATORS. THE NON CONFORMANCE HAS BEEN INVESTIGATED AND CLOSED. THEREFORE THIS COMPLAINT CAN BE CLOSED AND NO FURTHER ACTIONS ARE REQUIRED. NO ADDITIONAL PATIENT/EVENT DETAILS HAVE BEEN PROVIDED TO DATE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. (B)(4).

    Additional Manufacturer Narrative · 1

    ADD'L INFORMATION WAS RECEIVED ON JULY 16, 2015. RETURNED PRODUCT WAS RECEIVED AT THE MANUFACTURING SITE. A QUALITY COMPLAINT INVESTIGATION WAS PERFORMED. ONE SAMPLE WAS RECEIVED TO ASSIST WITH THE INVESTIGATION. SAMPLE MET MINIMUM AEROSOL OUTPUT REQUIREMENT AT THE LOWER AIR FLOW RATE. IT DELIVERED 2.08ML. THE LOT # INITIALLY WAS REPORTED AS N/A ON THE ORIGINAL COMPLAINT FORM. HOWEVER, THE RETURNED SAMPLE CONTAINED THE LABEL OF PRODUCT 3773MM, LOT # 105415. THE EVALUATION OF ONE UNUSED RETURNED SAMPLE AND DETAILED BATCH REVIEW ON THE POSSIBLE LOT# THAT WAS RECEIVED ON THE RETURNED SAMPLE, INDICATED THAT NO DISCREPANCIES WERE FOUND. THERE IS NOT ENOUGH INFORMATION TO CONCLUDE THE PRODUCT DID NOT MEET SPECIFICATION AND PERFORM AS INTENDED. PRODUCT MONITORING REVIEWS WILL MONITOR FOR PRODUCT TRENDS IF THIS ISSUE WERE TO REOCCUR. NO FURTHER ACTIONS ARE REQUIRED, AND THE COMPLAINT WILL BE CLOSED. NO ADDITIONAL PATIENT/EVENT DETAILS HAVE BEEN PROVIDED TO DATE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. REPORTED TO THE FDA ON AUGUST 05, 2015.

    Description of Event or Problem · 1

    IT WAS REPORTED THE NEBULIZER FAILED TO NEBULIZE MEDICATION. NO PATIENT COMPLICATION WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    425422 OPTI-MIST PLUS MASK KIT NEBULIZER (DIRECT PATIENT INTERFACE) CAF UNOMEDICAL S.A. DE C.V. 3773MM

    Patients

    Seq Age Sex Outcome Treatment
    1