BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ESTEEM +

    MDR report key: 10389731 · Received August 11, 2020

    Report

    Report Number
    9618003-2020-12822
    Event Type
    Malfunction
    Date Received
    August 11, 2020
    Report Date
    July 24, 2020
    Manufacturer
    CONVATEC DOMINICAN REPUBLIC INC
    Product Code
    EZQ
    UDI-DI
    00768455188604
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHARMACIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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 0A05819 WAS MANUFACTURED ON 02/19/2020, IN CONVEX 1 PC LINE, WITH A TOTAL OF (B)(4) MARKET UNITS. COMPLIANCE ENGINEER PERFORMED A BATCH RECORD REVIEW ON 08/07/2020, 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, SYSTEM APPLICATION PRODUCT (SAP) MATERIAL IDENTIFICATION (ID) 1703638 AND MANUFACTURING ORDER (B)(4). THE BULK FOR THIS PRODUCT WAS MANUFACTURED IN THE LINE APS 4 AUTOMATED UNDER LOT NUMBER 9L03497 DESCRIPTION PCH ESTINVISI DRN STD WF TAN LG CVX EUR, SYSTEM APPLICATION PRODUCT (SAP) MATERIAL 1701435, QUANTITY (B)(4) MANUFACTURING DATE 12/03/2019, ORDER NUMBER 1512051 THE BATCH RECORD REVIEW SUPPORTS THAT THERE WERE NO DISCREPANCIES RELATED TO THE ISSUE REPORTED. PHOTOGRAPH, VIDEO AND/OR PHYSICAL SAMPLE EVALUATION: THERE ARE PHOTOGRAPHS ASSOCIATED WITH THIS CASE AND IN THESE, THE DEFECT REPORTED BY THE CUSTOMER CAN BE SEEN. NO UNUSED RETURN SAMPLE HAS BEEN RECEIVED FOR THIS COMPLAINT. CONCLUSION SUMMARY OF THE RELATED EVENT: BASED IN THE INVESTIGATION FINDINGS, THE ROOT CAUSE IDENTIFIED FOR THE ISSUE ¿WAFER OFF CENTER IN THE POUCH¿, REPORTED UNDER FAILURE MODE ¿SKIN BARRIER STARTER HOLE IS DEFECTIVE (E.G., MISALIGNMENT OR OFF CENTER), LEAKAGE MAY OCCUR¿ IS ATTRIBUTED TO: 1) MACHINE: THE INVESTIGATIVE PROCESS CONCLUDED THAT ALL THE MACHINERY/ TOOLING ITEMS USED IN THE MANUFACTURING PROCESS COMPLIED WHEN COMPARED AGAINST DRAWING AND PROCESS INSTRUCTION (PI) PI21-076 REV 37.0 SPECIFICATIONS; HOWEVER, AS PART OF THIS INVESTIGATION ON 10/MAY/2019, MAINTENANCE AND FACILITIES MANAGER AND SENIOR PROCESS ENGINEER PERFORMED A DEEP ASSESSMENT TO THE SUB-ASSEMBLY STATION OF THE CONVEX 1PC MACHINE IDENTIFYING THE CONDITIONS CAUSING THE WAFER OFF CENTER AND THE POSSIBLE SOLUTIONS TO CORRECT THE FAILURE. AS CONCLUSION OF THE ASSESSMENT, THE CHAIN THAT COORDINATES FLANGE LOADING STATION WITH ADHESIVE LOADING STATION NEEDED LUBRICATION AND THE CHAIN AND OTHER COMPONENTS OF THE MECHANISM NEEDED A CORRECTIVE MAINTENANCE. IN ORDER TO MAINTAIN THIS CONDITION IN THE LONG TERM, A DEEPER INTERVENTION OF THE MECHANISM IS REQUIRED. FURTHERMORE, REGARDING THE ROTARY TABLE STATION OF THE CONVEX 1PC MACHINE, IT WAS IDENTIFIED THAT DUE TO THE DEMANDS OF THE PROCESS, THE TOOLING (CUP POUCH URO 177A) USED TO MANUFACTURE THE URODRESS PRODUCT FAMILY REQUIRE A REDESIGN MODIFICATION TO REDUCE THE VARIABILITY WITHIN THE MANUFACTURING PROCESS. AS A CONTRIBUTOR FACTORS THE FOLLOWING OPPORTUNITIES FOR IMPROVEMENTS WERE IDENTIFIED: 2) PROCESS / METHOD INVESTIGATION: A) REFERENCE IN THE PROCESS INSTRUCTION (PI) PI21-076; SECTION 8.0 ¿QUALITY INSTRUCTIONS¿ THE APPLICABLE QC TOOLING USED FOR PRODUCT¿S QUALITY INSPECTION PURPOSE OF POUCH URO 177A PRODUCTS FAMILY IN ORDER TO ADDRESS MANUFACTURING PERSONNEL THE USE OF THEM. B) IDENTIFICATION OF THE DEFECT DURING THE MANUFACTURING PROCESS, IT SHOULD BE CONSIDERED THE IMPLEMENTATION OF A JOB AID FOR PRODUCT CENTRALIZATION OUT OF SPECIFICATION. 3) PROCESS / METHOD / MEASUREMENT INVESTIGATION A) INTRODUCE QC TOOLING USED FOR PRODUCT¿S QUALITY INSPECTION PURPOSE IN THE CALIBRATION PROGRAM TO GUARANTEE MEASUREMENT ASSURANCE. 4) MANPOWER: A) THERE ARE NOT MANPOWER CAUSES ASSOCIATED WITH THE ROOT CAUSE; EVEN THOUGH, OPPORTUNITY TO IMPROVE THE LOADING OF THE ADHESIVE DISC DURING THE MANUFACTURING PROCESS WAS IDENTIFIED BY IMPLEMENTING A STANDARD WORK INSTRUCTION FOR CONVEX 1PC TO INDICATE MANUFACTURING OPERATORS HOW TO PROPERLY LOAD THE ADHESIVE DISC. NO ISSUES WERE IDENTIFIED FOR MATERIAL AND ENVIRONMENT INVESTIGATIONS. A CORRECTIVE ACTIONS/PREVENTIVE ACTIONS (CAPA) PLAN WAS GENERATED FOR THE MITIGATE THE ROOT CAUSES IDENTIFIED. 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 2 OF 20. (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

    THE PATIENT BROUGHT HIM 2 UNITS OF WAFERS AND ALL HAD STARTER HOLES OFF CENTERED. THE PRODUCTS WERE NOT USED BY PATIENT. PHOTOGRAPHS DEPICTING THE ISSUE WERE RECEIVED FROM THE COMPLAINANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    853937 ESTEEM + POUCH, COLOSTOMY EZQ CONVATEC DOMINICAN REPUBLIC INC 416751 0A05819 00768455188604

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown