It was reported that during a hepatic chemoembolisation, using a three-way plastic stopcock, the cytotoxic mixture has to be mixed with radio opaque lipiodol and endospheres.Two syringes and a three way stopcock are used to create the mixture.The stopcock leaked during mixing (medwatch# 1820334-2017-00998).A second one leaked as well (medwatch#1820334-2017-00999).A third stopcock which was not designed for this use had to be used.Devices were not kept as they were covered with toxic solution.The patient did not experience any adverse effects due to this occurrence.
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Investigation - evaluation: a review of the complaint history, drawings, device history record, and quality control of the device was conducted during the investigation.The complaint device was not returned therefore, no physical examinations could be performed; however, a document based 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 this is the third complaint for the reported failure (leakage) associated with this lot number without benefit of visual, dimensional, or functional testing of the device, the manufacturer can not conclude with certainty what led to the reported failure; therefore, a definitive root cause could not be determined.Measures are being conducted to address this failure mode.We will continue to monitor for similar complaints.
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