BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVELIFE

    MDR report key: 8218535 · Received January 4, 2019

    Report

    Report Number
    9618003-2019-00164
    Event Type
    Malfunction
    Date Received
    January 4, 2019
    Manufacturer
    CONVATEC DOMINICAN REPUBLIC INC
    Product Code
    EXH
    PMA / PMN Number
    EXEMPT
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    LOT NUMBER 8C04926 WAS MANUFACTURED ON 04/10/2018 IN THE CONVEX 1PC LINE. A BATCH RECORD REVIEW WAS PERFORMED ON (B)(6)2019 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) 650832 MATERIAL IDENTIFICATION NUMBER 1211902 AND MANUFACTURING ORDER 1401230. THE BATCH RECORD REVIEW SUPPORTS THAT THERE WERE NO DISCREPANCIES RELATED TO THE ISSUE REPORTED. PHOTOGRAPH ASSOCIATED WITH THIS CASE IS AVAILABLE FOR EVALUATION. BASED ON THE INVESTIGATION FINDINGS, THE ROOT CAUSE IDENTIFIED FOR THE ISSUE ¿WAFER OFF CENTER IN THE POUCH¿, IS ATTRIBUTED TO: THE INVESTIGATIVE PROCESS CONCLUDED THAT ALL THE MACHINERY/ TOOLING ITEMS USED IN THE MANUFACTURING PROCESS COMPLIED WHEN COMPARED AGAINST DRAWING AND PROCESS INSTRUCTION SPECIFICATIONS; HOWEVER, AS PART OF THIS INVESTIGATION ON MAY 10, 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 MANUFACTURED 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: REFERENCE IN THE PROCESS INSTRUCTIONS ¿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. IDENTIFICATION OF THE DEFECT DURING THE MANUFACTURING PROCESS, IT SHOULD BE CONSIDERED THE IMPLEMENTATION OF A JOB AID FOR PRODUCT CENTRALIZATION OUT OF SPECIFICATION. INTRODUCE QUALITY CONTROL (QC) TOOLING USED FOR PRODUCT¿S QUALITY INSPECTION PURPOSE IN THE CALIBRATION PROGRAM TO GUARANTEE MEASUREMENT ASSURANCE. 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 INSTRUCTIONS FOR CONVEX 1PC TO INDICATE MANUFACTURING OPERATORS HOW TO PROPERLY LOAD THE ADHESIVE DISC. NO ISSUES WERE IDENTIFIED FOR MATERIAL AND ENVIRONMENT INVESTIGATIONS. A NON-CONFORMANCE WAS CREATED AND IS NOW COMPLETE. 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 HAS BEEN RECEIVED.

    Additional Manufacturer Narrative · 1

    (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. FDA REGISTRATION NUMBER: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE STARTER HOLE WAS OFF CENTER IN FIVE WAFERS. NO HARM REPORTED. PHOTOS DEPICTING THE REPORTED COMPLAINT ISSUE WERE PROVIDED BY THE COMPLAINANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    8716 ACTIVELIFE BAG, URINARY, ILEOSTOMY EXH CONVATEC DOMINICAN REPUBLIC INC 650832 8C04926

    Patients

    Seq Age Sex Outcome Treatment
    1