(b)(4).Evaluation summary: the device was returned and the reported crack in the hub was not confirmed; however, the leak was confirmed.Based on visual and functional analysis of the returned device, there is no indication of a product deficiency.A review of the lot history record revealed no non-conformances that would have contributed to this complaint.A query of the complaint handling database revealed no other similar incidents reported from this lot.Based on the reviewed information, no product deficiency was identified.
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