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Summary of event: as reported, a three-way plastic stopcock was leaking lipodol and chemo drugs.No unintended section of the device remained inside of the patient's body.No additional procedures were required due to the occurrence.No adverse effects were reported due to the occurrence.Investigation evaluation: reviews of the complaint history, device history record, manufacturing instructions, and quality control procedures were conducted during the investigation.The complainant did not return the complaint device to cook for investigation.In response to this incident, cook reviewed the dhr.The dhr for the complaint device lot records one relevant non-conformances for fitting, difficult to wire, will not wire for six scrap do not replace.A database search for complaints on the reported lot found no additional complaints reported from the field.The dhr for subassembly lot records no relevant nonconformances.A database search for complaints on these five lots found no additional complaints reported from the field.A database search for complaints on these three lots found no additional complaints reported from the field.Although these non-conformances are relevant to the reported failure mode, all non-conforming product was scrapped, there are 100% inspections to capture this non-conformance.Adequate inspection activities have been established, there is objective evidence that the dhr was fully executed, and no other lot related complaints that have been received from the field, it was concluded that there is no evidence that non-conforming product exists in house or in field this device does not come with an ifu.Cook received a complaint for a similar product experiencing a similar failure mode in complaint (b)(4).The physical examination of the complaint devices in (b)(4) found both used stopcocks were leaking and had cracks in the body.The investigation under (b)(4)concluded that the event was possibly due to component failure.Because of similarities between the two complaints, it is possible that the two events have a similar cause.Cook has concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.The complaint was confirmed based on customer testimony.Cook has concluded that component failure unrelated to manufacturing or design deficiencies contributed to this incident.Per the quality engineering risk assessment, no further action is required.The appropriate personnel have been notified and cook will continue to monitor for similar events this report is required by the fda under 21 cfr part 803 and is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement contained herein is intended to be an admission that any cook device is defective or malfunctioned, that a death or serious injury occurred, nor that any cook device caused, contributed to, or is likely to cause or contribute to a death or serious injury if a malfunction occurred.
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