All available information was investigated, and the reported difficult to flush could not be confirmed via returned device analysis.A review of the lot history record revealed no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history identified no similar incidents reported from this lot.Based on available information, a cause of the reported difficult to flush could not be determined as no issue was identified in returned device analysis.There is no indication of a product quality issue with respect to manufacture, design or labeling.
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