BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVELIFE

    MDR report key: 8888142 · Received August 13, 2019

    Report

    Report Number
    9618003-2019-05121
    Event Type
    Malfunction
    Date Received
    August 13, 2019
    Manufacturer
    CONVATEC DOMINICAN REPUBLIC INC
    Product Code
    EXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH RECORD REVIEW: A REVIEW THE BATCH RECORD OF LOT 7L02480 WAS PERFORMED IN ORDER TO IDENTIFY IF THERE WERE ANY IRREGULARITY WITHIN DOCUMENTATION THAT COULD BE RELATED TO THE MALFUNCTION. THE REVISION SHOWED THE FOLLOWING: LOT 7L02480 WAS MANUFACTURED ON 11/15/2017, IN THE CONVEX ONE PIECE MANUFACTURING LINE WITH A TOTAL OF (B)(4) MARKET UNITS. ALL THE COMPONENTS UTILIZED WERE CORRECT PER BOM AND UNDER ICC CODE 650829, SAP MATERIAL ID 1211899 AND MANUFACTURING ORDER (B)(4). THE PROCESS REQUIREMENTS RESULTS WERE DOCUMENTED IN THE PRODUCT BATCH RECORDS MR21-076, VERSION 29.0. THE PRODUCT WAS PACKED AND LABELED UNDER THE PACKAGING AND LABELING SPECIFICATION 1211899. THE TESTING RESULTS WERE FOUND SATISFACTORY AND THE CREW REQUIREMENTS AND RESPONSIBILITIES, QUALITY AND IN-PROCESS INSPECTIONS, LINE OPERATIONS, PROCESS TROUBLESHOOTING AND RELEVANT DOCUMENTS TO THE PROCESS WERE RUN ACCORDING THE PROCESS INSTRUCTIONS PI21-076. THEREFORE, NO DISCREPANCY RELATED TO THIS ISSUE WERE FOUND WITHIN THE DOCUMENTATION. RETURNED SAMPLE EVALUATION: THERE ARE NO PHOTOGRAPHS ASSOCIATED WITH THIS CASE AND NO UNUSED RETURN SAMPLE WAS EXPECTED. 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 ¿OST-PMC1.8 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 PI21-076 REV 37.0 SPECIFICATIONS; HOWEVER, AS PART OF THIS INVESTIGATION ON 10/MAY/2019, MAINTENANCE AND FACILITIES MANAGER (AURYS ARIAS) AND SENIOR PROCESS ENGINEER (ALEJANDRO SOSA) 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: 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 INSTRUCTIONS FOR CONVEX 1PC TO INDICATE MANUFACTURING OPERATORS HOW TO PROPERLY LOAD THE ADHESIVE DISC. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. 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

    INITIAL REPORTER: (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. MDR 9618003-2019-05121 / DEVICE 4 OF 5. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED PRODUCT WITH "OFF CENTER STARTER HOLE". THE PRODUCT WAS NOT USED BY THE END USER, NO HARM REPORTED. NO PHOTOGRAPHS DEPICTING THE REPORTED COMPLAINT ISSUE SUBMITTED BY THE COMPLAINANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    681909 ACTIVELIFE BAG, URINARY, ILEOSTOMY EXH CONVATEC DOMINICAN REPUBLIC INC 650829 7L02480

    Patients

    Seq Age Sex Outcome Treatment
    1 Female