The device was not returned for analysis.A review of the lot history record identified 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 from this lot.The investigation was unable to determine a conclusive cause for the reported tip contamination.The reported difficulty to insert appears to be related to operation context of the procedure as it is likely the reported contamination blocked the tip lumen causing the reported difficulty to insert.There is no indication of a product quality issue with respect to manufacture, design or labeling.Na.
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