(b)(4).The device was returned.All available information was investigated and the reported detachment of device component (dilator rhv cap) was confirmed.Additionally, the rhv was observed to be broken.A review of the lot history record revealed no manufacturing nonconformities issued to the reported lot.Additionally, a review of the complaint history identified no other incidents reported from this lot.The investigation was unable to determine a definitive cause for the reported rhv cap detachment and broken rhv.There is no indication of a product quality issue with respect to manufacture, design, or labeling.
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It was reported that the cap of the rotating hemostatic valve (rhv) on the dilator was closed and flushed without issue.When the cap was being turned to open, the cap fell off.Attempt was made to screw the cap back on, but was not able to be re-attached.There was no patient involvement.Another dilator was used to complete the procedure.No additional information was provided.Analysis of the returned device identified the hemostatic valve was broken at the y connector.
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