BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NATURA

    MDR report key: 9318456 · Received November 13, 2019

    Report

    Report Number
    9618003-2019-07979
    Event Type
    Injury
    Date Received
    November 13, 2019
    Manufacturer
    CONVATEC DOMINICAN REPUBLIC INC
    Product Code
    EXE
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    LOT 7B04470 WAS MANUFACTURED ON 21 FEBRUARY 2017, IN THE CONVEX 2 PC BUILDING 8, WITH A TOTAL OF 2,000 MARKET UNITS. COMPLAINT INVESTIGATOR 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 (ICC) 413183 SYSTEM APPLICATION PRODUCT (SAP) MATERIAL IDENTIFICATION 1161272 AND MANUFACTURING ORDER 1331079 . 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. THIS INVESTIGATION APPLIES TO ALL FAMILY PRODUCTS MANUFACTURED ON CONVEX 2PIECE (PC) MANUAL LINE LOCATED IN HAINA MANUFACTURING SITE, BUILDING 8A FOR FAILURE MODE: SKIN BARRIER STARTER HOLE IS DEFECTIVE (E.G. MISALIGNMENT OR OFF CENTER), LEAKAGE MAY OCCUR. A TARGETED ROOT CAUSE INVESTIGATION FOR THESE KNOWN ISSUES/MALFUNCTION CODES HAS BEEN CONDUCTED. THE MANUFACTURING PROCESS INCLUDING EQUIPMENT PERFORMANCE, QUALITY INSPECTIONS AND QUALITY CONTROL RECORDS WERE REVIEWED. THE USE OF THE 6 M¿S METHODOLOGY TO EXPLORE AND ANALYZE PROBABLE CAUSES WAS COMPLETED. THE ROOT CAUSE INVESTIGATION IDENTIFIED TOOLING AS THE ROOT CAUSE AND OPPORTUNITIES TO IMPROVE THE TOOLING AT THE WAFER LOADING STATION OF THE CONVEX 2PC MANUAL LINE. THIS IS THE STATION WHERE THE ADHESIVE MASS IS APPLIED TO THE CONVEX INSERT. THE ROOT CAUSE INVESTIGATION PROGRESSED TO THE CORRECTIVE/PREVENTATIVE ACTION (CAPA) STAGE UNDER THE PARENT CAPA RECORD. THE CORRECTIVE ACTION WAS TO IMPLEMENT NEW TOOLING. THIS NEW TOOLING PASSED THE PERFORMANCE QUALIFICATION (PQ) VALIDATION PHASE AND WAS IMPLEMENTED MAY 24, 2019, INTO FULL PRODUCTION. ALL OPERATORS WERE TRAINED ON THE REVISED STANDARD WORK INSTRUCTIONS (SWI) AS PART OF IMPLEMENTATION OF THE NEW TOOLING. IN ADDITION, THE SWI WAS ADDED TO THE TRAINING CURRICULUM FOR THE OPERATORS. CONTAINMENT ACTIONS WERE ALSO IMPLEMENTED AND INCLUDE: SLOWING THE MANUFACTURING LINE (E.G. REDUCING THE SPEED TO ALLOW MORE TIME FOR THE MANUAL PLACEMENT OF THE MASS ONTO THE ASSEMBLY); IMPLEMENTED 100 PERCENT INSPECTION; AWARENESS TRAINING OF OPERATORS FOR THE MALPOSITION OF THE STARTER HOLE WAS CONDUCTED; AND STOPPED PRODUCING SEVERAL CODES WHICH HAD A HIGHER PROBABILITY OF STARTER HOLE OFF-CENTEREDNESS. THIS INVESTIGATION IS CLOSED, AND ALL CORRECTIVE ACTIONS HAVE BEEN IMPLEMENTED. 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

    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 9618003-2019-07979 / DEVICE 8 OF 10. (B)(4).

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1113531 NATURA PROTECTOR, OSTOMY EXE CONVATEC DOMINICAN REPUBLIC INC 404593 7J01301

    Patients

    Seq Age Sex Outcome Treatment
    1