DUODERM

Description of Event or Problem

The distributor complained regarding the presence of foreign matter inside the dressings. The product was not used. The photographs depicting the issue were received from the complainant.

Additional Manufacturer Narrative

MDR 9618003-2026-01642 / Device 224 of 467.E1: (b)(4). Initially, two eMDRs with Patient ID 2660172 (MFG report number: 9618003-2026-00863) and Patient ID 2700782 (MFG report number: 9618003-2026-00920) were submitted. However, samples were received and quantity was reconfirmed as total (b)(4) for this event. As additional affected quantity was confirmed, therefore, additional eMDRs are being submitted to reported additional quantity.Based on the available information, this event is deemed to be a reportable malfunction. Batch Record Review: Lot 5F01417 was manufactured on 06/JUN/2025, in DOYEN B Line, with a total of (b)(4) units. The Complaints Engineer performed a batch record review on 30/JUN/2026, 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) 1738482 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 defect reported by the customer could occur during the Sub-Assembly process performed in the Extrusion, Lamination & Cutting process (ELC) #11 manufacturing line. For this reason, a detailed batch record review was performed of the subassembly lot manufactured in this line. The subassembly Lot: 5F01485, Order 1846667, Material 1003411, was manufactured on 06/09/2025 in the Extrusion, Lamination & Cutting process (ELC) #11 Manufacturing line, with a total of (b)(4) Each (EA). The Complaint Engineer performed a batch record review on 30/JUN/2026, and it was confirmed that the applicable procedures were followed, the materials were correct as per Bill of Materials (BOM), and the Equipment Settings were according to the Process instruction.Photograph, video and/or physical sample evaluation:There were photographs associated with this case, and in these, the reported defect can be seen. Physical Samples were received:A total of (b)(4) units reporting "TP5-7: Foreign matter." were received. Upon evaluation of samples, the defect was confirmed in (b)(4) units.Refer to the tab ¿Reference Info / Comments¿ in the Complaint Investigation record: "30JUN2026 - Sample Evaluation Lot: 5F01417 Historical Complaints Review:On 30/JUN/2026, Complaints Engineer ran a query in database in order to verify the complaints reported for the 5F01417 lot for the Malfunction "Foreign matter within product, Sterile products (e.g. Metal contamination in dressings, particulates within fluids, gels etc)¿ defect, specifically the failure mode "Foreign matter" and only one additional complaint was identified; however, it corresponds to the same customer (JayWave) and the related portion of the lot was inspected and reported after this complaint was created. No adverse trend has been identified. Historical Nonconformance Review:On 30/JUN/2026, Complaints Engineer ran a query in database looking for any in process Nonconformance / Corrective Action / Preventive Actions (CAPA) associated to the Malfunction "Foreign matter within product, Sterile products (e.g. Metal contamination in dressings, particulates within fluids, gels etc)¿ defect, specifically the failure mode "Foreign matter" for the lot number 5F01417 and as result, no Nonconformance / Corrective Action / Preventive Actions (CAPA) for this Malfunction Code were generated during the manufacturing process of the referenced lot. Current Quality Controls:Based on the Process Instructions, the following tests are performed in the manufacturing lines, in order to identify this failure mode in our manufacturing process: Test Methods (TM) "Sterile Packaging Inspection for nonconformities - Visual Attributes": Frequency first units and every 30 minutes. Sample Quantity: 1 market unit o Not less than (NLT) 5 chevrons. Acceptance Criteria: Accept = 0/ Reject = 1.Based on the Process Instructions, the following tests are performed in the manufacturing lines, in order to identify this failure mode in our manufacturing process: Test Methods (TM) "Visual Nonconformities - Laminated Adhesive Products": Frequency: first unit and every 30 minutes. Sample Quantity: 2 samples at each process control point. Acceptance Criteria: Accept = 0/ Reject = 1.Defect Rate AnalysisThere have been 467 (based on the sample received) defective parts confirmed to date from a Lot size of 144,000 products. This represents a defect rate of 0.324%, which was well within an appropriate Acceptable quality level (AQL) for this defect which should be 1.00% based on our Standard Operating Procedure (SOP). In addition, all of the in-process testing on this Lot did not find a single defective unit, which confirms that the Lot was unlikely to breach an AQL of 1.00. To date, it was well within our accepted AQL level for this type of failure mode or defect.Conclusion:A review of batch records 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 discrepancies 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 NumberReporting Site: 1049092Manufacturing Site: 9618003.