Device 13 of 18, (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.(b)(4).
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Additional information - this emdr is being submitted to include the below: h3: device evaluated by mfg? h6: investigation results under imdrf cause investigation code, imdrf investigation findings, imdrf cause conclusions h10: investigation summary a batch record review was completed, and no discrepancies were found.Aquacel foam ag adh 10x10cm 1x10pk nai was manufactured under system application product (sap) code 1705403 and manufacturing lot number 2c03689 on 28 march 2022.Lot # 2c03689 was sterilized under work order 3098806 and released on review of results of sterilization provided by sterilization company sterigenics.All the results were within specification and products were released.No nonconformity was identified during the manufacturing process of lot 2c03689.Two photographs and a video were received for this issue and has been evaluated in accordance with work instruction (wis).The photographs confirm the expected lot number, product, and complaint issue, where yellow-brown diffused spots can be seen on the dressing pad at the point of intersection of the silicone border and the release liner fold.The video shows a primary sachet being opened to reveal brown spots on the dressing inside.The samples under complaint were requested for investigation on 01 december 2022 and received on 16th december 2022.A nonconformance was opened for a previous complaint received with an identical failure mode.The nonconformance now covers four (04) complaints against four (04) different batches for the same failure mode.Root cause analysis has identified the brown spots were caused by lubricant transfer from the kiss cut tool during conversion process on delta one (01) manufacturing line.Sample analysis identified this is a mix of lubricant spray and isopropyl alcohol (ipa) cleaner, although it has not been possible to replicate the issue.Several root causes and contributing root causes were identified, and corrective and preventive actions (capa) has been opened to address improvements to prevent recurrence.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: 1000317571.
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