Event summary: cook was informed of an incident involving a three-way plastic stopcock.The device reportedly leaked during an unspecified procedure.The event occurred twice (2 devices) during the same procedure.The patient reportedly experienced no adverse effects, no additional harm was reported.Investigation ¿ evaluation: a visual inspection of the returned device was conducted.A document-based investigation was also performed including a review of complaint history, device history record, drawing, the instructions for use, manufacturing instructions, and quality control data.The complainant returned a used device to cook for investigation.Physical examination of the returned device showed: two used stopcocks received.Inspection found both have cracks in the stopcock body, and both stopcocks leaked during leak test.The reported failure was evident to investigators.A review of the device history record (dhr) found no non-conformances related to the reported failure mode.Because there are no related non-conformances, adequate inspection activities have been established, there is objective evidence that the dhr was fully executed, and no other related complaints from the lot have been received from the field, it was concluded that there is no evidence that nonconforming product exists in house or in field.A review of complaint history records shows one other complaint associated with the complaint device lot.It was reported by the same user facility for the same failure mode.Based on the provided evidence and the completed investigation, cook has concluded component failure contributed to this incident.Per the quality engineering risk assessment, no further action is warranted.Cook medical will continue to monitor this device via the complaints database for similar complaints.This report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.
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