(b)(4).The device was not returned for analysis.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot.Additionally, a review of the complaint history identified no other incidents reported from this lot.All available information was investigated and a definitive cause for the reported leak (loss of fluid column) in this incident could not be determined.There is no indication of a product quality issue with respect to manufacture, design or labeling.
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