Additional information provided in h.6.And h.10.A review of the device history record traceable to the reported lot number indicates that the product was processed and released according to the product¿s acceptance criteria.No physical sample has been returned for evaluation, therefore, the condition of the product could not be verified.A review of the reported pak's bill of materials (bom) shows each unit should include (1pk) kn7317- sponge,gauze,16ply,xry,4x4,10s.A review of the deviation history report shows this lot did have a temporary deviation applied on the unavailable kn7317- sponge,gauze,16ply,xry,4x4,10s to be substituted with available alternative menon25430- sponge,gauze,16ply,xry,4x4.A review of the sap where-used parts list shows all (1,040ea) menon25430- sponge,gauze,16ply,xry,4x4 were built into this finished goods lot.One recommendation is that the customer contact their account manager about placing the sponge gauze in a glassine bag in their paks.Doing this would help prevent the potential spread of lint from the gauze and the transfer of lint from other products onto the gauze.Additionally, the account manager can work with the houston sales admin team for suggestions on low-lint products.The root cause of the customer's complaint is related to dissatisfaction of the approved temporary deviation for this built finished goods lot.The deviation will not apply to future lots manufactured after the supplier backorder is resolved.No further action will be pursued at this time.Based on current tracking, there are no adverse trends for this reported complaint.Quality assurance has reviewed this complaint and will continue to monitor data for evidence of adverse trending.The manufacturer internal reference number is: (b)(4).
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