BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NATURA

    MDR report key: 10094939 · Received May 28, 2020

    Report

    Report Number
    9618003-2020-11756
    Event Type
    Malfunction
    Date Received
    May 28, 2020
    Manufacturer
    CONVATEC DOMINICAN REPUBLIC INC
    Product Code
    EXE
    UDI-DI
    00768455124503
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA
    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 H10: INVESTIGATION SUMMARY BATCH RECORD REVIEW: LOT 9K03700 WAS MANUFACTURED ON (B)(6) 2019 IN THE CONVEX 2PC LINE WITH A TOTAL OF 4,032 MARKET UNITS. COMPLAINT INVESTIGATOR PERFORMED A BATCH RECORD REVIEW ON (B)(6) 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 (B)(4) SYSTEM APPLICATION PRODUCT (SAP) MATERIAL ID (B)(4) AND MANUFACTURING ORDER (B)(4). THE BATCH RECORD REVIEW SUPPORTS THAT THERE WERE NO DISCREPANCIES RELATED TO THE ISSUE REPORTED. RETURNED SAMPLE EVALUATION: PHOTO RELATED TO THE REPORTED PROBLEM IS 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: A) CONDITION OF THE YAMAHA ARM B) CONDITION OF VISION SYSTEM CAMERAS C) 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: (B)(4) MANUFACTURING SITE: (B)(4).

    Description of Event or Problem · 0

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

    Additional Manufacturer Narrative · 1

    DEVICE 24 OF 40. 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

    THE END USER REPORTED THAT 40 OUT OF 90 WAFERS FROM A TOTAL OF 9 MARKET UNITS HAD OFF CENTERED STARTER HOLES. THE PRODUCTS WERE NOT USED. A PHOTOGRAPH DEPICTING THE ISSUE WAS RECEIVED FROM THE END USER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    562659 NATURA PROTECTOR, OSTOMY EXE CONVATEC DOMINICAN REPUBLIC INC 413180 9K03700 00768455124503

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown