Investigation - evaluation: a review of the complaint history, drawings, dimensional verification, device history record, instructions for use (ifu), manufacturing instructions, trends, quality control and visual inspection of the returned device was conducted during the investigation.One used pericardiocentesis catheter set was returned for evaluation that included clear connecting tubing with one fitting on each end with an attached three way stopcock.The device was visually examined then functionally leak tested.Two cracks are noted at base of stopcock; the first crack is measured 3 mm in length and the second is 4 mm in length.Stopcock was liquid leak tested and failed.A document based investigation evaluation was also performed as part of this investigation.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, examination of the returned device and the results of our investigation, a definitive root cause of the observed cracks could not be determined.We will continue to monitor for similar complaints.Per the quality engineering risk assessment no further action is required.
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