(b)(4).Investigation - evaluation: a review of the complaint history, drawings, dimensional verification, device history record, function test, manufacturing instructions, trends, quality control and visual inspection of the returned device was conducted during the investigation.The visual inspection of the returned device reported one used stopcock.The stopcock had two cracks; both cracks are located at the base of the stopcock.One is 3 mm in length and the other is 1 mm in length.Each is on opposite sides of the male connection.Stopcock was liquid tested and failed.The complaint device was returned therefore, an investigation evaluation was performed.There is no evidence to suggest the product was not made to specifications.Review of device history record shows no nonconforming events which could contribute to this failure mode.It should be noted there were no other reported complaints for this lot number.Based on the information provided, and the results of our investigation, a definitive root cause could not be determined.We will continue to monitor for similar complaints.Per the quality engineering risk assessment no further action is required.
|