BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NATURA

    MDR report key: 9919322 · Received April 3, 2020

    Report

    Report Number
    9618003-2020-09438
    Event Type
    Malfunction
    Date Received
    April 3, 2020
    Manufacturer
    CONVATEC DOMINICAN REPUBLIC INC
    Product Code
    EXE
    UDI-DI
    00768455124534
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION - THIS EMDR IS BEING SUBMITTED TO INCLUDE THE BELOW: D4: UNIQUE IDENTIFIER (UDI). H6: INVESTIGATION RESULTS UNDER IMDRF CAUSE INVESTIGATION CODE, IMDRF INVESTIGATION FINDINGS, IMDRF CAUSE CONCLUSIONS. AN INVESTIGATION WAS COMPLETED FOR THIS COMPLAINT BY THE ASSIGNED MANUFACTURING SITE INVESTIGATION TEAM. THE COMPLAINT SUMMARY OF THIS INVESTIGATION REQUIRED REWORK. A CORRECTIVE ACTIONS/PREVENTIVE ACTIONS (CAPA) WAS RAISED, AND AN UPDATED/CORRECTED INVESTIGATION SUMMARY HAS BEEN COMPLETED IN ACCORDANCE WITH ASSIGNED CAPA. A SUPPLEMENTAL MDR IS BEING SUBMITTED TO DOCUMENT THE COMPLETION OF INVESTIGATION REWORK AND FINAL INVESTIGATION; THE COMPLAINT RECORD WILL PROCEED TO CLOSURE. BATCH RECORD REVIEW: LOT 9J02342 WAS MANUFACTURED ON 09/26/2019 IN THE CONVEX 2PC LINE WITH A TOTAL OF (B)(4) MARKET UNITS. COMPLAINT INVESTIGATOR PERFORMED A BATCH RECORD REVIEW ON 08/06/2020 TO VERIFY IF ALL THE APPLICABLE PROCEDURES WERE FOLLOWED AND NO ISSUES WERE FOUND; ALL THE COMPONENTS FOR ASSEMBLY WERE CORRECT PER BILL OF MATERIALS (BOM) AND ALL THE TOOLING INFORMATION DOCUMENTED WAS ALSO CORRECT, UNDER INTERNATIONAL COMMODITY CODE (ICC) CODE 413183 SYSTEM APPLICATION PRODUCT (SAP) MATERIAL ID 1161272 AND MANUFACTURING ORDER (B)(4) . THE BATCH RECORD REVIEW SUPPORTS THAT THERE WERE NO DISCREPANCIES RELATED TO THE ISSUE REPORTED. RETURNED SAMPLE EVALUATION: PHOTOS RELATED TO THE REPORTED PROBLEM ARE AVAILABLE FOR EVALUATION. INVESTIGATION SUMMARY: V. INVESTIGATION CONCLUSION: MATERIAL, METHOD/PROCESS, MANPOWER AND MEASUREMENT SECTIONS WERE REVIEWED, AND IT IS CONSIDERED NONE OF THEM INTERFERED ON THE INCIDENCE OF THE ROOT CAUSE, ALSO, THESE SECTIONS AND POSSIBLE OPPORTUNITIES WERE PREVIOUSLY COVERED. BASED ON THE INVESTIGATION FINDINGS THROUGH REVISION OF THE BATCH RECORDS DOCUMENTATION, PROCESS OBSERVATION, PERSONNEL INTERVIEWED, METHODOLOGY IMPLEMENTED, THE ROOT CAUSE FOR THIS FAILURE MODE WAS IDENTIFIED AS MACHINE. AS OBSERVED DURING THIS INVESTIGATION THE CONTRIBUTOR FACTORS TO THIS FAILURE MODE WERE THE FOLLOWING: CONDITION OF THE YAMAHA ARM. CONDITION OF VISION SYSTEM CAMERAS. VARIANCE IN THE MATERIALS, CAUSE VARIATION IN THE PLACEMENT. THIS IS CAUSING THE OVERALL VARIATION 0.6. THIS ACCUMULATION OF VARIATION CAUSES THE COMPLAINT IN SECTION 1. TO MAINTAIN ACCEPTABLE LEVELS OF VARIATION THE MAINTENANCE FOR THE ARM WILL BE IMPROVED. AND BASE ON THE RATE OF COMPLAINTS AND THE VARIATION IDENTIFY, CODES WITH A RATE HIGHER THAN 10 COMPLAINTS PER MILLION WILL BE BLOCK AND MANUFACTURED ON THE IMPROVE CONVEX 2 PC IN BUILDING 8A. THE INVESTIGATION ASSOCIATED WITH RELATED EVENT HAS BEEN APPROVED AND IS COMPLETE. NO ADDITIONAL ACTION IS REQUIRED, AND THIS COMPLAINT WILL BE CLOSED. THIS ISSUE WILL BE MONITORED THROUGH THE POST MARKET PRODUCT MONITORING REVIEW PROCESS. TO DATE NO ADDITIONAL INFORMATION HAS BEEN RECEIVED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. FDA REGISTRATION NUMBER: REPORTING SITE: 1049092. MANUFACTURING SITE: 9618003.

    Description of Event or Problem · 0

    TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.

    Additional Manufacturer Narrative · 1

    DEVICE 77 OF 80. (B)(6). BASED ON THE AVAILABLE INFORMATION, THIS EVENT IS DEEMED TO BE A REPORTABLE MALFUNCTION. TO DATE NO ADDITIONAL INFORMATION HAS BEEN RECEIVED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 80 OUT OF 100 WAFERS FROM THE SAME LOT HAD AN OFF CENTERED STARTER HOLE. THE AFFECTED PRODUCTS WERE NOT USED ON PATIENTS. PHOTOGRAPHS DEPICTING THE ISSUE WERE RECEIVED FROM THE COMPLAINANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    385564 NATURA PROTECTOR, OSTOMY EXE CONVATEC DOMINICAN REPUBLIC INC 413183 9J02342 00768455124534

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown