It was reported, during an unspecified procedure, the three-way plastic stopcock leaked during the mix of lipidol / chemotherapy.There was a reported product mix loss of 4cc.The doctor had to make a 2nd attempt.No additional information has been received.An associated report, #1820334-2017-00326.
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Investigation - evaluation.A review of the drawings, device history record, documentation, instructions for use (ifu), manufacturing instructions, specifications, drawings, trends, and quality control was conducted during the investigation.The complaint device was not returned; therefore, device failure analysis and physical examination of the device used in this case could not be performed.A review of the non-conformance data, revealed one non-conformance for the complaint lot number.A complaint history review revealed this is the only complaint for this lot number.Based on the information provided and the results of our investigation, the root cause was determined to be design-related.Measures have been initiated to address this issue.We will notify the appropriate personnel and continue to monitor for similar complaints.
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