BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NATURA

    MDR report key: 9394574 · Received December 2, 2019

    Report

    Report Number
    9618003-2019-15421
    Event Type
    Malfunction
    Date Received
    December 2, 2019
    Manufacturer
    CONVATEC DOMINICAN REPUBLIC INC
    Product Code
    EXE
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH RECORD REVIEW: LOT 7F03152 WAS MANUFACTURED ON 06/21/2017 IN THE CONVEX 2 PIECE (PC) BUILDING 8, WITH A TOTAL OF (B)(4) MARKET UNITS. COMPLAINT INVESTIGATOR PERFORMED A BATCH RECORD REVIEW ON 12/27/2019 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) 413182 SYSTEM APPLICATION PRODUCT (SAP) MATERIAL IDENTITY DOCUMENT (ID) 1161271 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. CONCLUSION SUMMARY OF THE RELATED EVENT: THE PURPOSE OF THIS INVESTIGATIONS WAS TO DETERMINE THE ROOT CAUSE ASSOCIATED INVESTIGATION WAFER DISC DECENTRALIZATION, COMPLAINT MALFUNCTION (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 WAS NOT CONSTANT, IT HAD PEAKS OF OCCURRENCE DURING THE PROCESS, IT WAS OBSERVED THAT THE ACTUAL TESTING METHOD (RANDOM HOURLY SAMPLING) MAY NOT CAPTURED EFFECTIVELY THE DEFECTS PRIOR TO PACKAGING, SO IT WAS SUGGESTED THE IMPLEMENTATION OF A CONTINUOUS TESTING METHOD TO ANTICIPATE TO ALL OF THE PEAKS. 2. MANPOWER OPPORTUNITY: A CERTIFICATION OF THE OPERATORS WHO HAD DIRECT INFLUENCE DUE TO THE ¿FLANGE/WAFER LOADING¿ PROCESS IN THE OPERATION THEY WERE 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 WAS CONSIDERED THAT DUE TO THE OBSERVATIONS REGISTERED, MACHINERY WAS THE ROOT CAUSE OF THIS INCIDENT. IT WAS CONCLUDED THAT ALL THE MACHINERY/ TOOLING ITEMS COMPLIED WHEN COMPARED AGAINST DRAWING AND PROCEDURE 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 WERE 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. 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 9618003-2019-15421 / DEVICE 44 OF 60. 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 60 WAFERS FROM 6 BOXES HAD OFF-CENTERED STARTER HOLES. THE PRODUCTS WERE NOT USED. NO PHOTO IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1187831 NATURA PROTECTOR, OSTOMY EXE CONVATEC DOMINICAN REPUBLIC INC 413182 7F03152

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown