BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DUODERM

    MDR report key: 21948535 · Received May 2, 2025

    Report

    Report Number
    9618003-2025-01569
    Event Type
    Malfunction
    Date Received
    May 2, 2025
    Date of Event
    February 24, 2025
    Report Date
    April 7, 2025
    Manufacturer
    CONVATEC DOMINICAN REPUBLIC INC
    Product Code
    NAD
    UDI-DI
    00768455106929
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    MDR (B)(4). D3: MANUFACTURER PHONE: +1 809-289-2221 E1: NAME OF AFFILIATION: (B)(4) INITIALLY, TWO EMDRS WITH PATIENT ID (B)(6) (MFG REPORT NUMBER: 9618003-2025-01045) AND PATIENT ID (B)(6) (MFG REPORT NUMBER: 9618003-2025-01102) WERE SUBMITTED. HOWEVER, SAMPLES WERE RECEIVED AND QUANTITY WAS RECONFIRMED AS TOTAL 96 FOR THIS EVENT. AS ADDITIONAL AFFECTED QUANTITY WAS CONFIRMED, THEREFORE, ADDITIONAL EMDRS ARE BEING SUBMITTED TO REPORTED ADDITIONAL QUANTITY. BASED ON THE AVAILABLE INFORMATION, THIS EVENT IS DEEMED TO BE A REPORTABLE MALFUNCTION. PHOTOGRAPH, VIDEO AND/OR PHYSICAL SAMPLE EVALUATION: THERE IS A PHOTOGRAPH ASSOCIATED WITH THIS CASE AND IN IT, THE REPORTED DEFECT CAN BE SEEN. 96 SAMPLES WERE RECEIVED FOR THE REPORTED CONDITION, THESE WERE SUBSEQUENTLY TESTED AND AS A RESULT, THE REPORTED DEFECT WAS CONFIRMED. BATCH RECORD REVISION RESULTS: LOT 4D01653 WAS MANUFACTURED ON 10/APR/2024, IN BODOLAY LINE, WITH A TOTAL OF 240000 MARKET UNITS (MKUS). THE COMPLAINTS INVESTIGATOR PERFORMED A BATCH RECORD REVIEW ON 16/APR/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 (B)(4). 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 DISCREPANCY RELATED TO THIS ISSUE WERE FOUND WITHIN THE DOCUMENTATION. THE DEFECT REPORTED BY THE CUSTOMER COULD OCCUR DURING THE DRESSING CUT 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 LOTS 4C05598 & 4C03196, ORDERS 1756974 & 1750848, MATERIAL 1003411, WERE MANUFACTURED ON 4/05/2024 & 3/17/2024 IN THE ELC#11 MANUFACTURING LINE, WITH A TOTAL OF (B)(4) EACHES. THE COMPLAINT INVESTIGATOR PERFORMED A BATCH RECORD REVIEW ON 16/APR/2025 AND IT WAS CONFIRMED THAT THE APPLICABLE PROCEDURES WERE FOLLOWED, THE COMPONENTS FOR ASSEMBLY WERE CORRECT AS PER 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 COMPLAINTS REVIEW: ON 16/APR/2025, COMPLAINTS INVESTIGATOR RAN A QUERY IN DATABASE IN ORDER TO VERIFY THE COMPLAINTS REPORTED FOR THE 4D01653 LOT FOR THE MALFUNCTION " FOREIGN MATTER WITHIN PRODUCT, STERILE PRODUCTS (E.G. METAL CONTAMINATION IN DRESSINGS, PARTICULATES WITHIN FLUIDS, GELS ETC)" DEFECT AND NO ADDITIONAL COMPLAINTS WERE IDENTIFIED. HISTORICAL NONCONFORMANCE REVIEW: ON 16/APR/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 4D01653 AND AS RESULT, NO NONCONFORMANCE / CAPA (S) FOR THIS MALFUNCTION WERE GENERATED DURING THE MANUFACTURING PROCESS OF THE REFERENCED LOT. CURRENT QUALITY CONTROLS: BASED ON THE 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: (B)(4)UNITS PER HOUR · SAMPLE QUANTITY: (B)(4) UNITS PER SHIFT · ACCEPTANCE CRITERIA: ACCEPT = 0 / REJECT = 1 DEFECT RATE ANALYSIS: THERE HAVE ONLY BEEN 96 DEFECTIVE PARTS CONFIRMED TO DATE FROM A LOT SIZE 240000 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. 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 AQL OF (B)(4). THIS ISSUE CERTAINLY APPEARS TO BE AN ISOLATED INCIDENT, BUT MORE IMPORTANTLY TO DATE, IT IS WELL WITHIN OUR ACCEPTED AQL LEVEL FOR THIS TYPE OF FAILURE MODE OR DEFECT. CONCLUSIONS: AS A PHOTOGRAPH WAS AVAILABLE FOR THIS COMPLAINT ISSUE, IT WAS EVALUATED, ADDITIONALLY, SAMPLES FOR THE REPORTED ISSUE WERE RECEIVED AND LATER EVALUATED 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 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. ADDITIONALLY, NO HARM WAS REPORTED DUE TO THIS COMPLAINT ISSUE, AND THE REPORTED UNIT WASN'T UTILIZED. 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 DARK-COLORED FOREIGN PARTICLES WERE FOUND EMBEDDED IN THE ADHESIVE/HYDROCOLLOID OF DRESSING, WHICH WERE GREATER THAN 0.1 SQUARE MILLIMETERS (MM²) IN SIZE. THE ISSUE WAS FOUND ON 24 FEB 2025. THE PRODUCT WAS NOT USED BY THE PATIENT. A PHOTOGRAPH DEPICTING THE ISSUE WAS RECEIVED FROM THE COMPLAINANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    208042 DUODERM DRESSING,WOUND,OCCLUSIVE NAD CONVATEC DOMINICAN REPUBLIC INC 412002 4D01653 00768455106929

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown