BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DUODERM

    MDR report key: 21824380 · Received April 11, 2025

    Report

    Report Number
    9618003-2025-01474
    Event Type
    Malfunction
    Date Received
    April 11, 2025
    Date of Event
    March 18, 2025
    Report Date
    March 18, 2025
    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

    MDR . / DEVICE 2 OF 2. E1: COMPLAINANT STREET ADDRESS: 74, HWANGGEUM-RO 109BEON-GIL, YANGCHON-EUP. COMPLAINANT CITY: GIMPO-SI COMPLAINANT STATE: GYEONGGI-DO COMPLAINANT COUNTRY: KOREA, REPUBLIC OF COMPLAINANT PHONE: 010-3260-0175 NAME OF AFFILIATION: JAYWAVE INC. SAMPLES ARE REQUESTED BUT THEY ARE NOT RECEIVED YET FOR EVALUATION. 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.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION - THIS EMDR IS BEING SUBMITTED TO INCLUDE THE BELOW: D8: WAS THIS DEVICE EVER SERVICED BY A THIRD PARTY? D9: IS THIS DEVICE AVAILABLE FOR EVALUATION? H6: INVESTIGATION RESULTS UNDER TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, INVESTIGATION CONCLUSIONS H11: INVESTIGATION SUMMARY PHOTOGRAPH, VIDEO AND/OR PHYSICAL SAMPLE EVALUATION: THERE WAS A PHOTOGRAPH ASSOCIATED WITH THIS CASE AND IN IT, THE REPORTED DEFECT CAN BE SEEN. 2 SAMPLES WERE RECEIVED FOR THE REPORTED CONDITION, THESE WERE SUBSEQUENTLY TESTED AND AS A RESULT, THE REPORTED DEFECT WAS CONFIRMED. BATCH RECORD REVIEW: LOT 4D01659 WAS MANUFACTURED 16/APR/2024, IN BODOLAY LINE, WITH A TOTAL OF (B)(4) MARKET UNITS (MKUS). THE COMPLAINTS INVESTIGATOR PERFORMED A BATCH RECORD REVIEW ON 23/MAY/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) (B)(4) 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 REPORTED MALFUNCTION COULD BE GENERATED DURING THE MANUFACTURING PROCESS OF THE FINAL LINE, THEREFORE NO FURTHER BATCH RECORD REVIEW OF THE SUBASSEMBLY LOTS WAS REQUIRED. HISTORICAL COMPLAINTS REVIEW: ON 23/MAY/2025, COMPLAINTS INVESTIGATOR RAN A QUERY IN DATABASE IN ORDER TO VERIFY THE COMPLAINTS REPORTED FOR THE 4D01659 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 COMPLAINTS WERE IDENTIFIED. HISTORICAL NONCONFORMANCE REVIEW: ON 23/MAY/2025, COMPLAINTS INVESTIGATOR RAN A QUERY IN DATABASE LOOKING FOR ANY IN PROCESS NONCONFORMANCE / CORRECTIVE AND 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 4D01659 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 (PI), THE FOLLOWING TESTS ARE PERFORMED IN THE MANUFACTURING LINES, IN ORDER TO IDENTIFY THIS FAILURE MODE IN OUR MANUFACTURING PROCESS: VISUAL INSPECTION: FREQUENCY: 80 POUCHES PER HOUR. SAMPLE QUANTITY: (B)(4) POUCHES PER SHIFT. PRELIMINARY INVESTIGATION RESULTS: THE REPORTED CONDITION WAS FOUND BY THE 100% INSPECTION PERFORMED BY THE DISTRIBUTOR, NO HARM HAS BEEN REPORTED FOR THE OBSERVED FAILURE MODE, ADDITIONALLY, NO END USER CAME IN CONTACT WITH ANY UNITS REPORTEDLY AFFECTED BY THE OBSERVED CONDITION, THE DEFECT RATE WAS CALCULATED TO BE (B)(4), WHICH IS WITHIN THE ACCEPTABLE QUALITY LEVEL (AQL) FOR THE REPORTED FAILURE MODE, WHICH IS 0.40 AS PER PROCESS INSTRUCTION (PI). DEFECT RATE ANALYSIS: THERE HAVE ONLY BEEN 2 DEFECTIVE PARTS CONFIRMED TO DATE FROM A LOT SIZE OF (B)(4) UNITS. THIS REPRESENTS A DEFECT RATE OF (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 (PI). THIS ISSUE CERTAINLY APPEARS TO BE AN ISOLATED INCIDENT, BUT MORE IMPORTANTLY TO DATE, IT IS WELL WITHIN OUR ACCEPTED ACCEPTABLE QUALITY LEVEL (AQL) 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. THE DEFECT RATE ANALYSIS FOR THIS ISSUE IS WITHIN THE APPROPRIATE ACCEPTABLE QUALITY LEVEL (AQL). 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. CONTROLS ARE IN PLACE FOR THE DETECTION OF THE REPORTED CONDITION. IN ADDITION, THE DEFECT WAS REPORTED FOR A DISTRIBUTOR THAT PERFORMS A 100% INSPECTION. 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 PRIMARY PACKAGE HAD OPEN SEAL (NONE ALLOWED). THE PRODUCT WAS NOT USED BY PATIENT. A PHOTOGRAPH DEPICTING THE ISSUE WAS RECEIVED FROM 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
    1007538 DUODERM DRESSING,WOUND,OCCLUSIVE NAD CONVATEC DOMINICAN REPUBLIC INC 412002 4D01659

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown