A sample was not received, therefore, the condition of the product could not be verified.No lot number was identified with this complaint.Therefore, a device history record review could not be conducted.A sample was not received at the manufacturing site, and no lot information is available.Therefore, the root cause for the customer complaint issue cannot be determined.Investigations have been completed.And manufacturing process enhancements have been implemented in order to improve the performance of the valves.The manufacturer internal reference number is: (b)(4).
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