BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DUODERM

    MDR report key: 15526572 · Received October 3, 2022

    Report

    Report Number
    9618003-2022-05058
    Event Type
    Malfunction
    Date Received
    October 3, 2022
    Report Date
    September 8, 2022
    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

    INITIAL REPORTER NAME AND ADDRESS: (B)(6). 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. FDA REGISTRATION NUMBER: (B)(4).

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION - THIS EMDR IS BEING SUBMITTED TO INCLUDE THE BELOW: H6: INVESTIGATION RESULTS UNDER IMDRF CAUSE INVESTIGATION CODE, IMDRF INVESTIGATION FINDINGS, IMDRF CAUSE CONCLUSIONS. 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 1L02297 WAS MANUFACTURED ON 11/17/2021, IN DOYEN B LINE, WITH A TOTAL OF (B)(4) MARKET UNITS (MKUS). THE COMPLAINT INVESTIGATOR PERFORMED A BATCH RECORD REVIEW ON 25/SEP/2023, 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 1000915 AND MANUFACTURING ORDER (B)(4) . THE PRODUCTION PROCESS, IN-PROCESS CONTROL, TESTING RESULTS AND PACKAGING OF PRODUCTS WAS RUN ACCORDING TO THE APPLICABLE PROCESS INSTRUCTION. 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 25/SEP/2023, COMPLAINT INVESTIGATOR RAN A QUERY IN DATABASE FROM 01/JAN/2022 TO 25/SEP/2023 IN ORDER TO VERIFY THE COMPLAINTS REPORTED FOR THE LOT NUMBER 1L02297 FOR THE MALFUNCTION CODE ¿FOREIGN MATTER WITHIN PRODUCT, STERILE PRODUCTS (E.G. METAL CONTAMINATION IN DRESSINGS, PARTICULATES WITHIN FLUIDS, GELS ETC)¿ AND AS RESULT, NO ADDITIONAL COMPLAINTS WERE FOUND. HISTORICAL NONCONFORMANCE REVIEW: ON 25/SEP/2023, COMPLAINT INVESTIGATOR RAN A QUERY IN DATABASE LOOKING FOR ANY IN PROCESS NONCONFORMANCE / CORRECTIVE ACTION/PREVENTIVE ACTION (CAPA) (S) ASSOCIATED TO THE MALFUNCTION CODE ¿FOREIGN MATTER WITHIN PRODUCT, STERILE PRODUCTS (E.G. METAL CONTAMINATION IN DRESSINGS, PARTICULATES WITHIN FLUIDS, GELS ETC)¿ FOR THE LOT NUMBER 1L02297 AND AS RESULT, NO NONCONFORMANCE / CORRECTIVE ACTION / PREVENTIVE ACTIONS (CAPA (S) FOR THIS MALFUNCTION CODE WERE GENERATED DURING THE MANUFACTURING PROCESS OF THE REFERENCED LOT. DEFECT RATE ANALYSIS: THERE HAS ONLY BEEN 1 DEFECTIVE PART CONFIRMED TO DATE FROM A LOT SIZE OF 135,000 PRODUCTS. THIS REPRESENTS A DEFECT RATE OF ONLY (B)(4) WHICH IS WELL WITHIN AN APPROPRIATE ACCEPTABLE QUALITY LEVEL (AQL) FOR FOREIGN MATTER ISSUES 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 AN ADHESIVE ISSUES, WHICH CONFIRMS THAT THE LOT IS UNLIKELY TO BREACH AN ACCEPTABLE QUALITY LEVEL (AQL) OF 0.25. 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: THERE IS A PHOTOGRAPH ASSOCIATED WITH THIS CASE AND IN THIS, THE REPORTED DEFECT CAN BE SEEN. NO UNUSED RETURN SAMPLE WAS EXPECTED. THE 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 NONCONFORMITY HAS BEEN REGISTERED DURING THE MANUFACTURING PROCESS OF THE AFFECTED LOT FOR THE MALFUNCTION CODE ¿FOREIGN MATTER WITHIN PRODUCT, STERILE PRODUCTS (E.G. METAL CONTAMINATION IN DRESSINGS, PARTICULATES WITHIN FLUIDS, GELS ETC)¿. NO ADDITIONAL COMPLAINTS WERE REPORTED FOR LOT AFFECTED RELATED TO THE MALFUNCTION CODE ¿FOREIGN MATTER WITHIN PRODUCT, STERILE PRODUCTS (E.G. METAL CONTAMINATION IN DRESSINGS, PARTICULATES WITHIN FLUIDS, GELS ETC)¿. BASED ON THIS, NO NEGATIVE TREND WAS IDENTIFIED. 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 THAT THERE WAS BARCODE LABEL FOUND INSIDE PRIMARY PACKAGE. LABEL WAS MIXED IN AN UNOPENED PRIMARY PACKAGE. THE PRODUCT WAS NOT USED. A PHOTOGRAPH DEPICTING THE ISSUE WAS RECEIVED FROM THE COMPLAINANT.

    Description of Event or Problem · 0

    TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2186073 DUODERM DRESSING,WOUND,OCCLUSIVE NAD CONVATEC DOMINICAN REPUBLIC INC 187955 1L02297

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown