BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    L3O0235 - S92S

    MDR report key: 11001370 · Received December 14, 2020

    Report

    Report Number
    9618003-2020-15501
    Event Type
    Malfunction
    Date Received
    December 14, 2020
    Report Date
    November 16, 2020
    Manufacturer
    CONVATEC DOMINICAN REPUBLIC INC
    Product Code
    EXE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHARMACIST
    Health Professional
    Yes

    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 9J04893 WAS MANUFACTURED ON 10/4/2019 IN THE CONVEX 2PC (OST) LINE, WITH A TOTAL OF (B)(4)MARKET UNITS PRODUCED. COMPLIANCE ENGINEER PERFORMED A BATCH RECORD REVIEW ON 16/APR/2021 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), UNDER INTERNATIONAL COMMODITY CODE (ICC) CODE (B)(4), SYSTEM APPLICATION PRODUCT (SAP) MATERIAL ID 1210693 AND MANUFACTURING ORDER (B)(4). THE PROCESS CARRIED OUT WAS RUN ACCORDING TO PROCESS INSTRUCTION (PI) PI21-108 AND DOCUMENTED IN MR21-108. IN ADDITION, THE BULK LOT 9J04900 WAS REVIEWED, MANUFACTURED IN THE CONVEX 2 PC (OST) LINE AND THE PROCESS CARRIED OUT, TOOLINGS USED AND IN-PROCESS QUALITY INSPECTIONS WERE FOUND TO PI21-107; THE PROCESS RESULTS WERE DOCUMENTED IN MR21-107. THE BATCH RECORD REVIEW CARRIED OUT SUPPORTS THAT THERE WERE NO DISCREPANCIES RELATED TO THE REPORTED DEFECT. RETURNED SAMPLE EVALUATION: NO UNUSED RETURN SAMPLE, PHOTO OR VIDEO WAS RECEIVED 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. ACTIONS FOR THESE CAUSES IDENTIFIED WERE TAKEN THROUGH CORRECTIVE ACTIONS/PREVENTIVE ACTIONS (CAPA) PLAN. 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 14 OF 25. COMMON NAME: PROTECTOR, OSTOMY. PRODUCT CODE: EXE. LISTING #: E584640. CLASS: CLASS I EXEMPT. (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 5 BOXES CAME WITH OFF CENTERED STARTED HOLE. THE END USER DID NOT EXPERIENCE A STOMA CUT BUT SOME STOMA RUBBING WITH NO OTHER INJURIES. NO PHOTO IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1465732 L3O0235 - S92S Protector, ostomy EXE CONVATEC DOMINICAN REPUBLIC INC 125028 9J04893

    Patients

    Seq Age Sex Outcome Treatment
    1 Female