(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.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 other incidents reported from this lot.The investigation was unable to determine a conclusive cause for the reported leak.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.
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It was reported that during use, when loosening the copilot bleedback control valve (bbcv), blood leaked out.A new copilot bbcv was used without further issue.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.
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