Investigation - evaluation: a review of the complaint history, drawings, device history record, manufacturing instructions, quality control, visual inspection, and functional testing of the returned devices and unused product was conducted during the investigation.Sixty-seven three-way plastic rotating adapter stopcocks were returned for investigation.Samples 1 through 65 were sealed unused stopcocks.Samples 66 and 67 were used stopcocks.None of the stopcocks examined showed visual defects; but, ten stopcocks did leak during testing.A document-based investigation evaluation was also 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 was one other reported complaint for this lot number.Based on the information provided and results of the investigation, a definitive root cause could not be determined.Measures have been previously conducted to address this failure mode.We will continue to monitor for similar complaints.Investigation - evaluation a review of the complaint history, drawings, device history record, manufacturing instructions, quality control, visual inspection, and functional testing of the returned devices and unused product was conducted during the investigation.Sixty-seven three-way plastic rotating adapter stopcocks were returned for investigation.Samples 1 through 65 were sealed unused stopcocks.Samples 66 and 67 were used stopcocks.None of the stopcocks examined showed visual defects; but, ten stopcocks did leak during testing.A document-based investigation evaluation was also 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 was one other reported complaint for this lot number.Based on the information provided and results of the investigation, a definitive root cause could not be determined.Measures have been previously conducted to address this failure mode.We will continue to monitor for similar complaints.
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