Samples received: 1 open box with 12 unopened pouches.Analysis and results: there are no previous complaints of any of the two involved products in the complaint.(b)(6) of the g1118161 and batch 116272 (dafilon 9/0) and (b)(4) of the g3095765 and batch 115312 were manufactured.All (b)(4) of the dafilon product were distributed and (b)(4) units of the optilene product are in stock.Received a box which contains 12 pouches.All pouches are of the reference-batch g3095765 (optilene 7/0)- 115312.The pre-printed box is of optilene too, but the box label corresponds to the reference-batch g1118161 (dafilon 9/0)- 116272.Products traceability has been checked and it has been determined that this mix-up took place at the moment of preparing the shipment in the warehouse.The operator took by mistake one optilene box and labeled it with the dafilon label.Moreover, it was not correctly checked that the product inside and product label were correct.We conclude that there are no more boxes affected.We manufactured (b)(4) (5 boxes) of the code batch g3095765 (optilene 7/0) batch 115312 and we have in our stock (b)(4), only 1 box was wrongly labeled and sent to one customer.Corrective/preventive actions: according to our internal procedures, there is no need to establish corrective or preventive actions.Nevertheless, this complaint is recorded for trending analysis to assess if actions are needed in the future.Moreover, activities have been proposed in order to avoid this issue to happen.
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