BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DUODERM

    MDR report key: 19677567 · Received July 5, 2024

    Report

    Report Number
    9618003-2024-02348
    Event Type
    Malfunction
    Date Received
    July 5, 2024
    Report Date
    June 11, 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

    ADDITIONAL INFORMATION - THIS EMDR IS BEING SUBMITTED TO INCLUDE THE BELOW: D9: DEVICE AVAILABLE FOR EVALUATION HAS BEEN SELECTED AS YES & DATE RETURNED TO MFG WAS ADDED AS WELL. H3: DEVICE EVALUATED BY MANUFACTURER? HAS BEEN SELECTED AS YES. H6: INVESTIGATION RESULTS UNDER TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, INVESTIGATION CONCLUSIONS. H11: INVESTIGATION SUMMARY: PHOTOGRAPH, VIDEO AND/OR PHYSICAL SAMPLE EVALUATION: THERE ARE PHOTOGRAPHS ASSOCIATED WITH THIS CASE AND IN THESE, THE REPORTED DEFECT CAN BE CONFIRMED. THERE WERE RECEIVED 1 PHYSICAL SAMPLE, TESTED, AND DOCUMENTED IN FORM CONFIRMING THE REPORTED CONDITION. REFER TO EVIDENCE ATTACHED 30SEP2024 PRIMARY PACKAGE ISSUE TEST EVIDENCE RECORD IN DATABASE. BATCH RECORD REVISION RESULTS: LOT 3D03508 WAS MANUFACTURED ON 28/APR/2023, IN BODOLAY MANUFACTURING LINE, WITH A TOTAL OF (B)(4). THE COMPLAINTS INVESTIGATOR PERFORMED A BATCH RECORD REVIEW ON 30/SEP/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 IDENTIFICATION (ID) 1000854 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. HISTORICAL COMPLAINTS REVIEW: ON 30/SEP/2024, COMPLAINTS INVESTIGATOR RAN A QUERY IN DATABASE IN ORDER TO VERIFY THE COMPLAINTS REPORTED FOR THE 3D03508 LOT FOR THE MALFUNCTION ¿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 COMPLAINT WAS IDENTIFIED. HISTORICAL NONCONFORMANCE REVIEW: ON 30/SEP/2024, COMPLAINTS INVESTIGATOR RAN A QUERY IN DATABASE LOOKING FOR ANY IN PROCESS NONCONFORMANCE / CORRECTIVE ACTION / PREVENTIVE ACTIONS (CAPA) (S) ASSOCIATED TO THE MALFUNCTION ¿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 3D03508 AND AS RESULT, NO NONCONFORMANCE / CAPA (S) FOR THIS MALFUNCTION 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 (B)(4). 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 0.65 BASED ON OUR PROCESS INSTRUCTION. IN ADDITION, ALL 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 0.65 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 PHYSICAL SAMPLE FOR THIS COMPLAINT ISSUE WAS RECEIVED, IT WAS EVALUATED AND AS A RESULT, THE REPORTED MALFUNCTION FOR THE OBSERVED PRODUCT WAS CONFIRMED. A DEFECT RATE ANALYSIS FOR THIS ISSUE WAS PERFORMED AND AS RESULT, 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. 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.

    Additional Manufacturer Narrative · 0

    E1: COMPLAINANT COUNTRY: (B)(6). DEALER: (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 REPORTING SITE: 1049092. MANUFACTURING SITE: 9618003.

    Description of Event or Problem · 0

    TO DATE, ADDITIONAL PATIENT OR EVENT DETAILS WERE RECEIVED WHICH HAVE BEEN ADDED IN H11 (ADDL MFG NARRATIVE).

    Description of Event or Problem · 0

    THE DISTRIBUTOR REPORTED THAT PRIMARY PACKAGE WAS ALREADY OPENED BEFORE USE. THE PRODUCT WAS NOT USED. THE PHOTOGRAPHS DEPICTING THE ISSUE WERE RECEIVED FROM THE COMPLAINANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    473915 DUODERM DRESSING,WOUND,OCCLUSIVE NAD CONVATEC DOMINICAN REPUBLIC INC 187660 3D03508

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown