BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVELIFE

    MDR report key: 9687435 · Received February 10, 2020

    Report

    Report Number
    9618003-2020-01435
    Event Type
    Malfunction
    Date Received
    February 10, 2020
    Manufacturer
    CONVATEC DOMINICAN REPUBLIC INC
    Product Code
    EZQ
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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 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 9K01303 WAS MANUFACTURED ON 10/15/2019, IN THE CONVEX 1PC LINE WITH A TOTAL OF (B)(4) EA. COMPLIANCE ENGINEER PERFORMED A BATCH RECORD REVIEW ON 08/08/2020, 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 125359, SYSTEM APPLICATION PRODUCT (SAP) MATERIAL ID 1172486 AND MANUFACTURING ORDER (B)(4). THE BATCH RECORD REVIEW SUPPORTS THAT THERE WERE NO DISCREPANCIES RELATED TO THE ISSUE REPORTED. THE CREW REQUIREMENTS AND RESPONSIBILITIES, PROCESS PARAMETERS, QUALITY AND IN-PROCESS INSPECTIONS, LINE OPERATIONS, PROCESS TROUBLESHOOTING AND RELEVANT DOCUMENTS TO THE PROCESS WERE RUN ACCORDING TO THE PROCESS INSTRUCTIONS PI21-076. PHOTOGRAPH, VIDEO AND/OR PHYSICAL SAMPLE EVALUATION: NO PHOTOGRAPH ASSOCIATED WITH THIS CASE WERE RECEIVED. NO UNUSED RETURN SAMPLE HAS BEEN RECEIVED FOR THIS COMPLAINT. CONCLUSION SUMMARY OF THE RELATED EVENT: BASED ON 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 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

    MDR 9618003-2020-01435 / DEVICE 4 OF 4. 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 SHE HAD 4 OUT OF 10 APPLIANCES THAT HAD OFF CENTERED STARTER HOLE. SHE USED ONE ANYWAY AND HAD TO CHANGE IT AFTER AN HOUR. THERE WAS NO HARM REPORTED BY THE COMPLAINANT. NO PHOTO IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    153202 ACTIVELIFE POUCH, COLOSTOMY EZQ CONVATEC DOMINICAN REPUBLIC INC 125359 9K01303

    Patients

    Seq Age Sex Outcome Treatment
    1 Female