BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DUODERM

    MDR report key: 21466454 · Received February 26, 2025

    Report

    Report Number
    9618003-2025-00969
    Event Type
    Malfunction
    Date Received
    February 26, 2025
    Date of Event
    January 8, 2025
    Report Date
    February 4, 2025
    Manufacturer
    CONVATEC DOMINICAN REPUBLIC INC
    Product Code
    NAD
    UDI-DI
    00768455106929
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    MDR 9618003-2025-00969 / DEVICE 169 OF 193 INITIALLY, TWO EMDRS WITH PATIENT ID 2111981 (MFG REPORT NUMBER: 9618003-2025-00396) AND PATIENT ID 2126461 (MFG REPORT NUMBER: 9618003-2025-00439) WERE SUBMITTED. HOWEVER, SAMPLES WERE RECEIVED AND QUANTITY WAS RECONFIRMED AS TOTAL 193 FOR THIS EVENT. AS ADDITIONAL AFFECTED QUANTITY WAS CONFIRMED, THEREFORE, ADDITIONAL EMDRS ARE BEING SUBMITTED TO REPORTED ADDITIONAL QUANTITY. E1: COMPLAINANT STREET ADDRESS: (B)(6) COMPLAINANT CITY:(B)(6) COMPLAINANT STATE/PROVINCE:(B)(6) COMPLAINANT COUNTRY: KOREA, REPUBLIC OF NAME OF AFFILIATION: JAYWAVE INC. BASED ON THE AVAILABLE INFORMATION, THIS EVENT IS DEEMED TO BE A REPORTABLE MALFUNCTION. PHOTOGRAPH, VIDEO AND/OR PHYSICAL SAMPLE EVALUATION: THERE WAS A PHOTOGRAPH ASSOCIATED WITH THIS CASE AND IN THIS, THE REPORTED DEFECT CAN BE SEEN. 618 SAMPLES WERE RECEIVED FOR THE CORRESPONDING LOT ON 24/JAN/2025 AND WERE SUBSEQUENTLY EVALUATED, AS A RESULT, THE REPORTED CONDITION WAS CONFIRMED. BATCH RECORD REVISION RESULTS: LOT 4C02961 WAS MANUFACTURED ON 14/MAR/2024 IN BODOLAY LINE, WITH A TOTAL OF (B)(4)MARKET UNITS (MKUS). THE COMPLAINTS INVESTIGATOR PERFORMED A BATCH RECORD REVIEW ON 06/FEB/2025, 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, SYSTEM APPLICATION PRODUCT (SAP) MATERIAL IDENTIFICATION (ID) 1738482 AND MANUFACTURING ORDER 1755218. REVIEW OF THE BATCH RECORD SHOWED THAT ALL RELEVANT TESTS REQUIRED DURING THE MANUFACTURING PROCESS AND FINAL PRODUCT RELEASE HAD BEEN FULFILLED AND MET THE REQUIREMENTS. NO DISCREPANCIES RELATED TO THIS ISSUE WERE FOUND WITHIN THE DOCUMENTATION. THE DEFECT REPORTED BY THE CUSTOMER COULD OCCUR DURING THE PROCESS PERFORMED IN THE ELC#11 MANUFACTURING LINE. FOR THIS REASON, A DETAILED BATCH RECORD REVIEW WAS PERFORMED OF THE SUBASSEMBLY LOT(S) MANUFACTURED IN THIS LINE. THE SUBASSEMBLY LOT 4C03196, ORDER 1750848, MATERIAL 1003411, WAS MANUFACTURED ON 17/MAR/2024 IN THE APS 6 AUTOMATED MANUFACTURING LINE, WITH A TOTAL OF(B)(4) EACHES. THE COMPLAINT INVESTIGATOR PERFORMED A BATCH RECORD REVIEW ON 06/FEB/2025 AND IT WAS CONFIRMED THAT THE APPLICABLE PROCEDURES WERE FOLLOWED, THE COMPONENTS FOR ASSEMBLY WERE CORRECT AS PER BILL OF MATERIALS (BOM) AND THE EQUIPMENT SETTINGS WERE THE APPLICABLE ONES. THE BATCH RECORD REVIEW SUPPORTS THAT THERE WERE NO DISCREPANCIES RELATED TO THE ISSUE REPORTED. HISTORICAL NONCONFORMANCE REVIEW: ON 06/FEB/2025, COMPLAINTS INVESTIGATOR RAN A QUERY IN DATABASE LOOKING FOR ANY IN PROCESS NONCONFORMANCE / CORRECTIVE ACTION / PREVENTIVE ACTIONS (CAPA) (S) ASSOCIATED TO THE MALFUNCTION ¿FOREIGN MATTER WITHIN PRODUCT, STERILE PRODUCTS (E.G. METAL CONTAMINATION IN DRESSINGS, PARTICULATES WITHIN FLUIDS, GELS ETC)¿ DEFECT FOR THE LOT NUMBER 4C02961 AND AS RESULT, NO NONCONFORMANCE / CORRECTIVE ACTION / PREVENTIVE ACTIONS (CAPA) (S) FOR THIS MALFUNCTION WERE GENERATED DURING THE MANUFACTURING PROCESS OF THE REFERENCED LOT. CURRENT QUALITY CONTROLS: BASED ON THE PROCESS INSTRUCTION PROCESS INSTRUCTION (PI), THE FOLLOWING TESTS ARE PERFORMED IN THE MANUFACTURING LINES, IN ORDER TO IDENTIFY THIS FAILURE MODE IN OUR MANUFACTURING PROCESS: VISUAL INSPECTION": ¿ FREQUENCY: 80 UNITS PER HOUR (640 UNITS PER SHIFT) ¿ SAMPLE QUANTITY: 80 POUCHES PER PALLET ¿ ACCEPTANCE CRITERIA: ACCEPT = 0 / REJECT = 1 DEFECT RATE ANALYSIS: THERE HAVE ONLY BEEN 453 DEFECTIVE PARTS CONFIRMED TO DATE FROM A LOT SIZE 360000 PRODUCTS. THIS REPRESENTS A DEFECT RATE OF ONLY(B)(4), WHICH IS WELL WITHIN AN APPROPRIATE ACCEPTABLE QUALITY LEVEL (AQL) FOR THIS DEFECT WHICH SHOULD BE(B)(4) BASED ON OUR PROCESS INSTRUCTION (PI). IN ADDITION, ALL OF THE IN-PROCESS TESTING ON THIS LOT DID NOT FIND A SINGLE DEFECTIVE UNIT, WHICH CONFIRMS THAT THE LOT IS UNLIKELY TO BREACH AN ACCEPTABLE QUALITY LEVEL (AQL) OF 4.00. THIS ISSUE CERTAINLY APPEARS TO BE AN ISOLATED INCIDENT, BUT MORE IMPORTANTLY TO DATE, IT IS WELL WITHIN OUR ACCEPTED ACCEPTABLE QUALITY LEVEL (AQL) FOR THIS TYPE OF FAILURE MODE OR DEFECT. CONCLUSIONS: AS A PHOTOGRAPH WAS AVAILABLE FOR THIS COMPLAINT ISSUE, IT WAS EVALUATED, ADDITIONALLY, THE SAMPLES SENT FOR EVALUATION WERE INSPECTED, AND AS A RESULT, THE REPORTED MALFUNCTION FOR THE OBSERVED PRODUCT WAS CONFIRMED, HOWEVER, AFTER PERFORMING THE DEFECT RATE ANALYSIS FOR THIS ISSUE, IT WAS OBSERVED THAT THE QUANTITY OF REPORTEDLY AFFECTED PRODUCTS IS WITHIN THE APPROPRIATE ACCEPTABLE QUALITY LEVEL (AQL) FOR THIS DEFECT. A BATCH RECORD REVIEW WAS COMPLETED AND SHOWED THAT ALL RELEVANT TESTS REQUIRED DURING THE MANUFACTURING PROCESS AND FINAL PRODUCT RELEASE HAD BEEN FULFILLED AND MET THE REQUIREMENTS. NO DISCREPANCY RELATED TO THIS ISSUE WERE FOUND WITHIN THE DOCUMENTATION. THIS ISSUE WILL BE MONITORED THROUGH THE POST MARKET PRODUCT MONITORING REVIEW PROCESS, STANDARD OPERATING PROCEDURE (SOP). 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

    THE DISTRIBUTOR REPORTED THAT THERE WAS FOREIGN PARTICLES AND SOILING OF PACKAGING MATERIALS. THE PRODUCT WAS NOT USED. A PHOTOGRAPH DEPICTING THE ISSUE WAS RECEIVED FROM THE COMPLAINANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    595986 DUODERM DRESSING,WOUND,OCCLUSIVE NAD CONVATEC DOMINICAN REPUBLIC INC 412002 4C02961 00768455106929

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown