BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    J001FO 1000ML JOEY FEED BAG TYPE X30

    MDR report key: 10680805 · Received October 14, 2020

    Report

    Report Number
    8040459-2020-00543
    Event Type
    Malfunction
    Date Received
    October 14, 2020
    Date of Event
    October 14, 2020
    Report Date
    December 9, 2020
    Manufacturer
    COVIDIEN
    Product Code
    LZH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    SINCE A LOT NUMBER WAS NOT PROVIDED, THE DEVICE HISTORY RECORD COULD NOT BE PERFORMED. AS PART OF OUR MANUFACTURING PROCESS, ALL DEVICE HISTORY RECORDS ARE REVIEWED AND APPROVED BY QUALITY, PRIOR TO RELEASE OF PRODUCT. THE ACTUAL COMPLAINT SAMPLE WAS RECEIVED FOR THE EVALUATION. THE SAMPLE WAS EVALUATED BY VISUAL INSPECTION AND PUMPING TESTER. A LEAKAGE WAS FOUND FROM THE CONNECTOR CAME FROM SILICONE TUBE DAMAGE. THEREFORE, THE REPORTED CONDITION IS CONFIRMED. THE FINITE ELEMENT ANALYSIS (FEA) CONDUCTED ON PREVIOUS INVESTIGATION WAS FOCUSED ON THE CENTER SIX CAVITIES. FROM THIS SIMULATION RESULTS WE LEARNED THAT THE MATERIAL FILLED FASTER IN THE CENTER CAVITIES COMPARED TO THE REST, THIS CREATES A BACKFILL CONDITION WHERE THE MATERIAL FLOWS INTO THE OTHER TUBES, WHICH ARE FILLING SLOWER. A NEW MOLD-FLOW ANALYSIS WAS CONDUCTED ON THE CURRENT TOOL USED TO UNDERSTAND ITS CURRENT STATE, AS A RESULT OF THIS STUDY IT WAS CONFIRMED THAT AIR BUBBLES WERE CAUSED BY THE ¿BACKFLOW¿ EFFECT. THE BACKFLOW IS A FUNCTION OF THE TOOL DESIGN. FOLLOWING THE RESULT, TOOLING MODIFICATIONS WERE DEVELOPED AND AN FEA SIMULATION WAS COMPLETED, INCLUDING ANALYZATION OF THE MODIFICATIONS¿ IMPACT ON THE BACKFLOW CONDITION. A QUOTE WAS PROVIDED FOR MODIFICATIONS PROPOSED TO THE TOOL. THE AIR BUBBLES FOUND IN THE SILICONE TUBING ARE CAUSED BY THE ¿BACKFLOW¿ EFFECT RESULTING FROM THE TOOL DESIGN. AS PART OF CONTINUOUS IMPROVEMENTS, A CORRECTIVE ACTION HAS BEEN OPENED AND THE BELOW ACTIONS HAS BEEN IMPLEMENTED: ROUTER INSTRUCTIONS FOR WORK ORDER WERE UPDATED. TRAINING WAS DONE FOR THE QUALITY ALERT TO INDICATE THE INSPECTION OF PARTS FOR BUBBLES. THREE RUNS WERE MOLDED OVER THREE SHIFTS. THIRTY SHOTS WERE COLLECTED PER RUN AND MEASURED FOR CRITICAL CHARACTERISTICS ON ELEVEN (11) CAVITIES DETERMINED TO HAVE THE HIGHEST STANDARD DEVIATION DURING THE OQ STUDY. ALL DIMENSIONAL RESULTS SHOW CAPABILITY AS ACCEPTABLE. PRODUCT THAT WAS IN-HOUSE WAS EVALUATED FOR THE NON-CONFORMING CONDITION. THE USE OF THE LIGHT TABLE WAS IMPLEMENTED TO AIDE IN DETECTING AIR BUBBLES DURING INSPECTION. A SORT OPERATOR WAS ADDED TO THE PROCESS TO CONDUCT A 100% IN LINE INSPECTION OF THE PARTS. A QUALITY ALERT WAS CREATED TO HIGHLIGHT THE CONDITION AND BRING GREATER OPERATOR AWARENESS, BOTH QUALITY AND PRODUCTION PERSONNEL WERE TRAINED. AS AN IMMEDIATE ACTION, THE PRODUCTS THAT WAS IN-HOUSE WAS PLACED ON HOLD FOR EVALUATION PURPOSE AND THE SUPPLIER CONDUCT 100% SCREEN THE AIR BUBBLE BEFORE ASSEMBLY. AS A PREVENTIVE ACTION, VALIDATION OF NEW PLATES AND TOOLS FOR THE MOLDING PROCESS OF JOEY TUBE HAVE BEEN SUCCESSFULLY COMPLETED.

    Additional Manufacturer Narrative · 1

    THE INCIDENT SAMPLE HAS BEEN REQUESTED BUT TO DATE HAS NOT BEEN RECEIVED FOR EVALUATION. IF THE SAMPLE IS RECEIVED, OR IF ADDITIONAL INFORMATION PERTINENT TO THE INCIDENT IS OBTAINED A FOLLOW-UP REPORT WILL BE SUBMITTED. AS PART OF OUR MANUFACTURING PROCESS, ALL DEVICE HISTORY RECORDS ARE REVIEWED, AND APPROVED BY QUALITY, PRIOR TO RELEASE OF PRODUCT.

    Description of Event or Problem · 1

    CUSTOMER REPORTS: A LEAKAGE OCCURRED FROM THE PUMP SET. THE LEAKAGE POINT WAS UNABLE TO BE IDENTIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1145388 J001FO 1000ML JOEY FEED BAG TYPE X30 PUMP, INFUSION, ENTERAL LZH COVIDIEN J001FO

    Patients

    Seq Age Sex Outcome Treatment
    1