BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DUODERM

    MDR report key: 19947773 · Received August 9, 2024

    Report

    Report Number
    9618003-2024-02592
    Event Type
    Malfunction
    Date Received
    August 9, 2024
    Report Date
    July 16, 2024
    Manufacturer
    CONVATEC DOMINICAN REPUBLIC INC
    Product Code
    NAD
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    E1: (B)(6). 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 THIS, THE REPORTED DEFECT CAN BE SEEN. NO UNUSED RETURN SAMPLE WAS EXPECTED. BATCH RECORD REVISION RESULTS: LOT 3B02907 WAS MANUFACTURED 3/9/2023, IN BODOLAY LINE, WITH A TOTAL OF (B)(6) (MKUS). THE COMPLAINTS INVESTIGATOR PERFORMED A BATCH RECORD REVIEW ON 19/JUL/2024, 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 ID 1000854 AND MANUFACTURING ORDER (B)(6). 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. HISTORICAL COMPLAINTS REVIEW: ON 19/JUL/2024, COMPLAINTS INVESTIGATOR RAN A QUERY IN DATABASE IN ORDER TO VERIFY THE COMPLAINTS REPORTED FOR THE 3B02907 LOT FOR THE MALFUNCTION CODE ¿PRIMARY PACK (STERILE PRODUCTS) HAS INCOMPLETE OR OPEN SEAL / WELD, OR IS TORN, RIPPED OR CONTAINS HOLES OR EXHIBITS EXTERNAL CONTAMINATION (E.G. WATER MARKS, STAINS), OR DRESSING OR LOOSE MATERIAL IS TRAPPED IN PACKAGING¿ DEFECT AND NO ADDITIONAL COMPLAINTS WERE IDENTIFIED. HISTORICAL NONCONFORMANCE REVIEW: ON 19/JUL/2024, COMPLAINTS INVESTIGATOR RAN A QUERY IN DATABASE LOOKING FOR ANY IN PROCESS NONCONFORMANCE / CORRECTIVE AND PREVENTIVE ACTIONS (CAPA) (S) ASSOCIATED TO THE MALFUNCTION CODE ¿PRIMARY PACK (STERILE PRODUCTS) HAS INCOMPLETE OR OPEN SEAL / WELD, OR IS TORN, RIPPED OR CONTAINS HOLES OR EXHIBITS EXTERNAL CONTAMINATION (E.G. WATER MARKS, STAINS), OR DRESSING OR LOOSE MATERIAL IS TRAPPED IN PACKAGING¿ DEFECT FOR THE LOT NUMBER 3B02907 AND AS RESULT, NO NONCONFORMANCE / CORRECTIVE AND PREVENTIVE ACTIONS (CAPA) (S) FOR THIS MALFUNCTION CODE 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: PARTICLES: FREQUENCY: 80 UNITS PER HOUR (640 UNITS PER TURN). SAMPLE QUANTITY: 640 UNITS PER TURN. ACCEPTANCE CRITERIA: ACCEPT = 1 / REJECT = 2. DEFECT RATE ANALYSIS: THERE HAVE ONLY BEEN 1 DEFECTIVE PARTS CONFIRMED TO DATE FROM A LOT SIZE (B)(6) 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 (B)(4) BASED ON 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 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) LEVEL FOR THIS TYPE OF FAILURE MODE OR DEFECT. CONCLUSIONS: AS A PHOTOGRAPH WAS AVAILABLE FOR THIS COMPLAINT ISSUE, IT WAS 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. 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

    IT WAS REPORTED BY DISTRIBUTOR THAT FOREIGN MATTER WAS ATTACHED TO THE PRIMARY PACKAGING. THE PRODUCT WAS NOT USED BY PATIENT. A PHOTOGRAPH DEPICTING THE ISSUE WAS RECEIVED FROM COMPLAINANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1674281 DUODERM DRESSING,WOUND,OCCLUSIVE NAD CONVATEC DOMINICAN REPUBLIC INC 187660 3B02907

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown