(b)(4).No visual, dimensional and functional inspection can be performed since the device sample is not available for eval.Failure mode could not be duplicated since is unk the reason why the aquapak is leaking, however, functional test was performed on (b)(4) subassembly (p/n: 12136) no issues or discrepancies were found.A device history record review could not be conducted since the lot number was not provided.No conclusion can be established at this time based on the lack of the device sample.It is necessary to have the device sample in order to perform a proper investigation.If the device sample becomes available this complaint will be reopened.The personnel involved in the mfg process were notified of this complaint.
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