BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COMBIHESIVE 2S WFR CVX 19/45MM(1X5PK)CEU

    MDR report key: 10013060 · Received April 30, 2020

    Report

    Report Number
    9618003-2020-10728
    Event Type
    Malfunction
    Date Received
    April 30, 2020
    Date of Event
    April 3, 2020
    Manufacturer
    CONVATEC DOMINICAN REPUBLIC INC
    Product Code
    EXE
    PMA / PMN Number
    UNK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    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 9C02096 WAS MANUFACTURED ON 03/20/2019 IN THE CONVEX 2 PC BUILDING 8, WITH A TOTAL (B)(4) MARKET UNITS. COMPLIANCE ENGINEER PERFORMED A BATCH RECORD REVIEW ON 07/31/2020 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 125028 SYSTEM APPLICATION PRODUCT (SAP) MATERIAL IDENTIFICATION (ID) 1012353 AND MANUFACTURING ORDER (B)(4). THE BATCH RECORD REVIEW SUPPORTS THAT THERE WERE NO DISCREPANCIES RELATED TO THE ISSUE REPORTED. RETURNED SAMPLE EVALUATION: NO PHOTOGRAPH ASSOCIATED WITH THIS CASE AND NO UNUSED RETURN SAMPLE WAS EXPECTED. SUMMARY OF THE RELATED EVENT: THE PURPOSE OF THIS INVESTIGATIONS WAS TO DETERMINE THE ROOT CAUSE ASSOCIATED INVESTIGATION WAFER DISC DECENTRALIZATION, COMPLAINT (SKIN BARRIER STARTER HOLE IS DEFECTIVE, E.G., MISALIGNMENT OR OFF CENTER, LEAKAGE MAY OCCUR), FOR LOTS MANUFACTURED IN CONVEX 2 PC BUILDING 8, HAINA, D.R. AFTER THE USE OF THE 6 M¿S METHODOLOGY TO DOCUMENT INVESTIGATION FINDINGS, EXPLORE AND ANALYZE PROBABLE CAUSES, IT WAS DETERMINED THE FOLLOWING ROOT CAUSES AND OPPORTUNITIES: 1. METHOD OPPORTUNITY: DUE TO THE FACT THAT THE OCCURRENCE OF THIS FAILURE MODE IS NOT CONSTANT, IT HAS PEAKS OF OCCURRENCE DURING THE PROCESS, IT IS OBSERVED THAT THE ACTUAL TESTING METHOD (RANDOM HOURLY SAMPLING) MAY NOT CAPTURED EFFECTIVELY THE DEFECTS PRIOR TO PACKAGING, SO IT IS SUGGESTED THE IMPLEMENTATION OF A CONTINUOUS TESTING METHOD TO ANTICIPATE TO ALL OF THE PEAKS. 2. MANPOWER OPPORTUNITY: A CERTIFICATION OF THE OPERATORS WHO HAVE DIRECT INFLUENCE DUE TO THE ¿FLANGE/WAFER LOADING¿ PROCESS IN THE OPERATION THEY ARE EXECUTING SHOULD BE CONSIDERED IN ORDER TO REDUCE THE LEARNING CURVE EFFECT IN PROCESS AND GUARANTEE THE TRAINING EFFECTIVENESS. THIS SHOULD BE PERFORMED IN CONJUNCT WITH THE QUALITY INSPECTOR, PROCESS ENGINEER OF SUCH LINE AND THE SUPERVISOR. 3. MACHINE: IT IS CONSIDERED THAT DUE TO THE OBSERVATIONS REGISTERED, MACHINERY IS THE ROOT CAUSE OF THIS INCIDENT. IT IS CONCLUDED THAT ALL THE MACHINERY/ TOOLING ITEMS COMPLIED WHEN COMPARED AGAINST DRAWING AND PROCESS INSTRUCTION (PI) SPECIFICATIONS, HOWEVER DUE TO THE DEMANDS OF THE PROCESS, THESE TOOLING REQUIRE A DIMENSION MODIFICATION TO REDUCE THE VARIABILITY OF THE PROCESS. LISTED BELOW ARE THE OBSERVATIONS. MISALIGNMENT OF THE WAFER LOADING PINS. MISALIGNMENT OF THE UPPER WAFER LOADING PLATE. FIXATION OF THE UPPER WAFER LOADING PLATE AND LOWER WAFER LOADING PLATE. ACTIONS WILL BE TAKEN FOR EACH FACTOR AND ARE GOING TO BE SUMMARIZED ON CORRECTIVE ACTION / PREVENTIVE ACTIONS (CAPA) PLAN. ACTIONS COVERED IN THIS INVESTIGATION WILL BE IMPLEMENTED IN CONVEX 2 PC BUILDING 8 INSIDE CONVATEC D.R., EXCEPT FOR AUTOMATIC CONVEX 2 PC, BECAUSE THE DESIGN AND FUNCTIONING OF THIS MACHINE IS DIFFERENT. 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 9618003-2020-10728 / DEVICE 2 OF 5. COMMON DEVICE CODE: PROTECTOR, OSTOMY. PROCODE: EXE. (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 ON (B)(6) 2020, THE WAFER WAS FOUND TO HAVE AN OFF CENTERED STARTER HOLE. THE PRODUCT WAS USED BY THE PATIENT. THERE WAS NO HARM REPORTED. NO PHOTO IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    476226 COMBIHESIVE 2S WFR CVX 19/45MM(1X5PK)CEU NOT APPLICABLE EXE CONVATEC DOMINICAN REPUBLIC INC 125028 9C02096

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown