BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NATURA

    MDR report key: 8394331 · Received March 6, 2019

    Report

    Report Number
    9618003-2019-01494
    Event Type
    Malfunction
    Date Received
    March 6, 2019
    Manufacturer
    CONVATEC DOMINICAN REPUBLIC INC
    Product Code
    EXE
    PMA / PMN Number
    EXEMPT
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    LOT 7M03576 WAS MANUFACTURED ON (B)(6)2017 IN THE CONVEX 2 PC BUILDING 8 LINE WITH A TOTAL OF 4,300 MARKET UNITS. COMPLAINT INVESTIGATOR ID 577 PERFORMED A BATCH RECORD REVIEW 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 402205, MATERIAL IDENTIFICATION 1052420. THE BATCH RECORD REVIEW SUPPORTS THAT THERE WERE NO DISCREPANCIES RELATED TO THE ISSUE REPORTED. NO PHOTOGRAPH ASSOCIATED WITH THIS CASE AND NO UNUSED RETURN SAMPLE WAS EXPECTED. THE PURPOSE OF THIS INVESTIGATIONS WAS TO DETERMINE THE ROOT CAUSE ASSOCIATED INVESTIGATION WAFER DISC DECENTRALIZATION, COMPLAINT MALFUNCTION CODE OST-PMC1.8 (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. IT WAS DETERMINED THE FOLLOWING ROOT CAUSES AND OPPORTUNITIES: 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. 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. 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 PROCEDURAL INSTRUCTION SPECIFICATIONS, HOWEVER DUE TO THE DEMANDS OF THE PROCESS, THESE TOOLING REQUIRE A DIMENSION MODIFICATION TO REDUCE THE VARIABILITY OF THE PROCESS. THE FOLLOWING OBSERVATIONS ARE: 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. 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: (B)(6). MANUFACTURING SITE: (B)(6).

    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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE STARTER HOLE IS OFF CENTER WITH THE FLEXIBLE PART AT ONE SIDE IS 1.2 CM AND AT THE OTHER SIDE IS 1.8 CM. PHOTOS DEPICTING THE REPORTED COMPLAINT ISSUE WERE PROVIDED BY THE COMPLAINANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    190334 NATURA PROTECTOR, OSTOMY EXE CONVATEC DOMINICAN REPUBLIC INC 402205 7M03576

    Patients

    Seq Age Sex Outcome Treatment
    1