BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    J011RO JOEY ADAPUTER TYPE X30

    MDR report key: 10203208 · Received June 26, 2020

    Report

    Report Number
    8040459-2020-00532
    Event Type
    Malfunction
    Date Received
    June 26, 2020
    Date of Event
    May 25, 2020
    Report Date
    September 24, 2020
    Manufacturer
    COVIDIEN
    Product Code
    LZH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND INDICATED THAT THE PRODUCT WAS RELEASED ACCOMPLISHING ALL QUALITY STANDARDS. ONE PHYSICAL SAMPLE WAS RECEIVED FOR THE EVALUATION. UPON VISUAL INSPECTION UNDER MICRO ZOOM, IT WAS FOUND THAT THE LEAKAGE POINT (HOLE IN THE TUBE) OCCURRED FROM THE SILICONE TUBE DAMAGE. THEREFORE, THE REPORTED CONDITION IS CONFIRMED. THE FINITE ELEMENT ANALYSIS (FEA) CONDUCTED ON THE INVESTIGATION FOCUSED ON THE CENTER SIX CAVITIES. FROM THIS SIMULATION RESULTS, IT WAS 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. AS PART OF CONTINUOUS IMPROVEMENTS, A CORRECTIVE ACTION (CAPA) HAS BEEN OPENED TO ADDRESS THIS ISSUE. THE CORRECTIVE AND PREVENTIVE ACTIONS INCLUDE: 1. THE PROCESS ROUTER INSTRUCTIONS WERE UPDATED TO INDICATE THE PART WERE TO BE INSPECTED. 2. TOOLING MODIFICATION AND VALIDATION HAS BEEN DEVELOPED. THE CORRECTIVE ACTIONS WERE APPLIED TO BOTH TOOLS THAT PRODUCE THESE PARTS. THERE ARE NO OTHER TOOLS WITH THIS SAME CONFIGURATION. 3. PRODUCT THAT WAS IN-HOUSE WAS EVALUATED FOR THE NON-CONFORMING CONDITION. 4. THE USE OF THE LIGHT TABLE WAS IMPLEMENTED TO AIDE IN DETECTING AIR BUBBLES DURING INSPECTION. 5. A SORT OPERATOR WAS ADDED TO THE PROCESS TO CONDUCT A 100% IN LINE INSPECTION OF THE PARTS. 6. A QUALITY ALERT WAS CREATED TO HIGHLIGHT THE CONDITION AND BRING GREATER OPERATOR AWARENESS, BOTH QUALITY AND PRODUCTION PERSONNEL WERE TRAINED. 7. THE PRODUCT THAT WAS IN-HOUSE WAS PLACES ON HOLD FOR EVALUATION PURPOSES. 8. 100% SCREENING WILL BE CONDUCTED TO DETECT THE AIR BUBBLE BEFORE ASSEMBLY.

    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

    THE CUSTOMER REPORTED THAT A LEAK OCCURRED FROM A HOLE IN THE TUBING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    663370 J011RO JOEY ADAPUTER TYPE X30 PUMP, INFUSION, ENTERAL LZH COVIDIEN J011RO 1928018FJY

    Patients

    Seq Age Sex Outcome Treatment
    1