BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DUODERM

    MDR report key: 18854295 · Received March 7, 2024

    Report

    Report Number
    9618003-2024-00272
    Event Type
    Malfunction
    Date Received
    March 7, 2024
    Report Date
    February 14, 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

    MDR 9618003-2024-00272 / DEVICE 1 OF 2 E1: COMPLAINANT CITY: (B)(6) COMPLAINANT STATE: (B)(6) COMPLAINANT COUNTRY: KOREA, REPUBLIC OF NAME OF AFFILIATION: (B)(6) (JW) 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: D9: DEVICE AVAILABLE FOR EVALUATION HAS BEEN SELECTED AS YES. H3: DEVICE EVALUATED BY MFG. H6: INVESTIGATION RESULTS UNDER TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, INVESTIGATION CONCLUSIONS. H11: INVESTIGATION SUMMARY: BATCH RECORD REVIEW: LOT 3C05902 WAS MANUFACTURED ON 31/MAR/2023, IN BODOLAY LINE, WITH A TOTAL OF (B)(4) MARKET UNITS (MKUS). COMPLAINT INVESTIGATOR PERFORMED A BATCH RECORD REVIEW ON 11/APR/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) 1738483 AND MANUFACTURING ORDER (B)(4). NO DISCREPANCY RELATED TO THIS ISSUE WERE FOUND WITHIN THE DOCUMENTATION. PHOTOGRAPH, VIDEO AND/OR PHYSICAL SAMPLE EVALUATION: THERE ARE PHOTOGRAPHS ASSOCIATED WITH THIS CASE AND IN THESE, THE REPORTED DEFECT CAN BE SEEN. RETURNED SAMPLES FROM (B)(6), WERE RE-INSPECTED TO CONFIRM DEFECTS AS PER CONVATEC INTERNAL PROCEDURES. CONCLUSION SUMMARY OF THE RELATED EVENT: INITIAL COMMUNICATIONS WITH (B)(6) (THE CUSTOMER) HIGHLIGHTED A DIFFERENCE OF CLASSIFICATION OF ALL VISUAL DEFECTS, IN RESPECT TO THE INTERNAL CRITERIA IN TEST METHODS AND PROCEDURES AT CONVATEC ADVANCED WOUND CARE (AWC) HAINA. AS WELL IT WAS NOTED THAT (B)(6) WAS PERFORMING A 100% INSPECTION, WHILE CONVATEC HAD VISUAL SAMPLING INSPECTION FOR LOW SEVERITY DEFECTS OF AN ACCEPTABLE QUALITY LEVEL (AQL) OF 4.00. DURING THE INVESTIGATION, THE TEAM EVALUATED THE CORRESPONDING BATCH RECORDS AND THEIR VISUAL INSPECTION. ALL LOTS WERE FOUND TO BE ACCEPTED, WITH NO NON-CONFORMANCE (NC)'S. ALL INSPECTION WERE PERFORMED ACCORDINGLY AS PER STANDARD OPERATING PROCEDURE (SOP), TEST METHODS (TM), PROCEDURE AND PROCESS INSTRUCTION (PI). MANUFACTURING SCRAP RATES WERE ALSO EVALUATED AND NO INCREASE ON MANUFACTURING RATES WERE NOTED. ALSO, RETURNED SAMPLES FROM (B)(6), WERE RE-INSPECTED TO CONFIRM DEFECTS AS PER CONVATEC INTERNAL PROCEDURES. THE RESULTS WERE NON-SURPASSING THE 4.00 ACCEPTABLE QUALITY LEVEL (AQL) INSPECTION. ALL DEFECTS IDENTIFIED CORRESPONDED TO VISUAL, LOW SEVERITY, DEFECTS. DURING THE INVESTIGATION, A 6M (METHODS, MACHINES, MATERIALS, MEASUREMENTS, MOTHER NATURE, AND MANPOWER) TOOL WERE USED TO PERFORM ANALYSIS ON POTENTIAL CAUSES, AND AS RESULTS, THE FOLLOWING CAUSE WAS IDENTIFIED: METHOD: THE INSPECTION METHODS, AND PRODUCTION METHODS DESCRIBED AND NOTED IN THE CORRESPONDING DOCUMENTS {E.G. STANDARD OPERATING PROCEDURE (SOP), TEST METHODS (TM), PROCEDURE AND PROCESS INSTRUCTION (PI)} WERE REVIEWED WITH NO OPPORTUNITIES. IT WAS IDENTIFIED THAT CONVATEC IS PERFORMING A SAMPLING-BASED INSPECTION WHILE (B)(6) (THE CUSTOMER) WAS DOING A 100% INSPECTION. THIS DIFFERENT CRITERIA OF LOW SEVERITY DEFECT COULD CONTRIBUTE AS TO (B)(6) FINDING DEFECTS. WHEN COMPARISON WAS DONE OF THE DEFECTS REJECTED BY (B)(6). IT WAS NOTED THAT ALTHOUGH 4 LOTS WERE REJECTED FROM (B)(6), THEY WOULD STILL BE LOWER THAT THE ACCEPTANCE QUALITY LIMIT (AQL). IT WAS ALSO NOTED THAT ALL LOT RETURNED DID NOT EXCEED THE ACCEPTABLE QUALITY LEVEL (AQL). FOR THIS REASON, IT CAN BE CONCLUDED THAT METHOD IS THE ROOT CAUSE OF THIS ISSUE SINCE THERE IS NO ALIGNMENT OF INSPECTION METHOD OR CRITERIA BETWEEN (B)(6) AND CONVATEC HAINA. CORRECTIVE AND PREVENTIVE ACTIONS: CORRECTIVE AND PREVENTIVE ACTIONS IDENTIFIED WILL BE TAKEN THROUGH CORRECTIVE ACTION / PREVENTIVE ACTIONS (CAPA) PLAN. THE INVESTIGATION ASSOCIATED WITH RELATED EVENT HAS BEEN APPROVED AND IS COMPLETE. NO ADDITIONAL ACTION IS REQUIRED, AND THIS COMPLAINT WILL BE CLOSED. 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 THEY FOUND CONTAMINATION IN PRIMARY PACKAGE MATERIAL. THE PRODUCT WAS NOT USED BY PATIENT. 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
    881379 DUODERM DRESSING,WOUND,OCCLUSIVE NAD CONVATEC DOMINICAN REPUBLIC INC 421578 3C05902

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown