BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DUODERM

    MDR report key: 21994481 · Received May 9, 2025

    Report

    Report Number
    9618003-2025-01513
    Event Type
    Malfunction
    Date Received
    May 9, 2025
    Report Date
    April 16, 2025
    Manufacturer
    CONVATEC DOMINICAN REPUBLIC INC
    Product Code
    NAD
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE AVAILABLE INFORMATION, THIS EVENT IS DEEMED TO BE A REPORTABLE MALFUNCTION. THIS COMPLAINT HAS BEEN EVALUATED AS A TYPE 2 CASE. PHOTOGRAPH, VIDEO AND/OR PHYSICAL SAMPLE EVALUATION: THERE WERE PHOTOGRAPHS ASSOCIATED WITH THIS CASE AND IN IT, THE REPORTED DEFECT WAS SEEN. NO UNUSED RETURN SAMPLE WAS EXPECTED. BATCH RECORD REVISION RESULTS: LOT 4C02151 WAS MANUFACTURED ON 14/MAR/2024, IN DOYEN B LINE, WITH A TOTAL OF (B)(4) MARKET UNITS (MKUS). THE COMPLAINTS INVESTIGATOR PERFORMED A BATCH RECORD REVIEW ON 30/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) 1000915 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 PROCESS PERFORMED IN THE ELC#(B)(4) MANUFACTURING LINE. FOR THIS REASON, A DETAILED BATCH RECORD REVIEW WAS PERFORMED OF THE SUBASSEMBLY LOT(S) MANUFACTURED IN THIS LINE. THE SUBASSEMBLY LOT 4C01559, ORDER (B)(4), MATERIAL 1003411, WAS MANUFACTURED ON 12/MAR/2024 IN THE ELC#(B)(4) MANUFACTURING LINE, WITH A TOTAL OF (B)(4) EACHES. THE COMPLAINT INVESTIGATOR PERFORMED A BATCH RECORD REVIEW ON 30/APR/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 COMPLAINTS REVIEW: ON 30/APR/2025, COMPLAINTS INVESTIGATOR RAN A QUERY IN DATABASE IN ORDER TO VERIFY THE COMPLAINTS REPORTED FOR THE 4C02151 LOT FOR THE MALFUNCTION "FOREIGN MATTER (E.G. HAIRS, INSECTS) WITHIN PRIMARY PACK (STERILE PRODUCTS)" DEFECT AND NO ADDITIONAL COMPLAINTS WERE IDENTIFIED. HISTORICAL NONCONFORMANCE REVIEW: ON 30/APR/2025, COMPLAINTS INVESTIGATOR RAN A QUERY IN DATABASE LOOKING FOR ANY IN PROCESS NONCONFORMANCE / CORRECTIVE AND PREVENTIVE ACTIONS (CAPA)(S) ASSOCIATED TO THE MALFUNCTION "FOREIGN MATTER (E.G. HAIRS, INSECTS) WITHIN PRIMARY PACK (STERILE PRODUCTS)" DEFECT FOR THE LOT NUMBER 4C02151 AND AS RESULT, NO NONCONFORMANCE / CORRECTIVE AND 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, THE FOLLOWING TESTS ARE PERFORMED IN THE MANUFACTURING LINES, IN ORDER TO IDENTIFY THIS FAILURE MODE IN OUR MANUFACTURING PROCESS: TEST METHODS (TM) "STERILE PACKAGING INSPECTION FOR NONCONFORMITIES - VISUAL ATTRIBUTES": · FREQUENCY: (B)(4) POUCHES PER HOUR. · SAMPLE QUANTITY: (B)(4) POUCHES PER SHIFT. · ACCEPTANCE CRITERIA: ACCEPT = 0 / REJECT = (B)(4). DEFECT RATE ANALYSIS: THERE HAVE ONLY BEEN (B)(4) DEFECTIVE PARTS CONFIRMED TO DATE FROM A LOT SIZE (B)(4) 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 STANDARD OPERATING PROCEDURE (SOP). 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 (B)(4). THIS ISSUE CERTAINLY APPEARS TO BE AN ISOLATED INCIDENT, BUT MORE IMPORTANTLY TO DATE, IT IS WELL WITHIN OUR ACCEPTED ACCEPTABLE QUALITY LEVEL (AQL) LEVEL FOR THIS TYPE OF FAILURE MODE OR DEFECT. CONCLUSIONS: AS PHOTOGRAPHS WERE AVAILABLE FOR THIS COMPLAINT ISSUE, THEY WERE 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 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. 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 NURSE REPORTED THAT THERE WAS A FOREIGN MATTER (CONTAMINANT HAIR) PRESENT ON THE PRODUCT. THE PRODUCT WAS NOT USED BY PATIENT. PHOTOGRAPHS DEPICTING THE ISSUE WERE RECEIVED FROM COMPLAINANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    998656 DUODERM DRESSING,WOUND,OCCLUSIVE NAD CONVATEC DOMINICAN REPUBLIC INC 187955 4C02151

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown