Corrected data: device available for evaluation.Device evaluated by manufacturer.Investigation - evaluation: a review of the complaint history, drawings, device history record, manufacturing instructions, trends, quality control and visual inspection of the returned device was conducted during the investigation.Five (5) three-way plastic stopcocks were returned in sealed package to assist with the investigation.All five were examined for non-conformities and tested for leaks.Two of the stopcocks passed, but three failed for cracks and/or leakage.A document based investigation evaluation was also performed.There is no evidence to suggest the product was not manufactured according to specifications.A review of the complaint history for this device was performed.It should be noted that there were no other reported complaints of this nature for this lot number.Measures have been conducted to address this failure mode.Monitoring will continue to be performed for similar complaints.Based on the information provided and the results of our investigation; a definitive root cause could not be determined.
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