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The account reported finding rotating adaptor separated from manifold.A sample was received for investigation; visual inspection was performed, finished good production records were reviewed, and the bill of materials (bom) and packaging instructions were reviewed.The visual inspection found the rotating adaptor (ra) to be separated from the manifold body, confirming the reported issue.The manifold specs are 200 psi static, 750 psi dynamic, not intended for use with power injection; based on the information received from the customer during the initial intake reporting form, this 200s manifold was being used outside of its intended design specs, with a power injector, which is considered customer misuse and therefore the root cause was not due to a product defect.There were no reports of death, serious injury, medical intervention, or follow up care.It has been determined that the reported event could cause or contribute to serious injury if it were to occur again.In an abundance of caution, this is a reportable event.If additional information becomes available this report will be reopened and reevaluated.This medical device report (mdr) is being submitted as part of retrospective review activities, which include review of historical data in accordance with regulations at 21 cfr part 803.The information included in this mdr reflects the information reasonably known to the manufacturer at the time of this retrospective review and submission.
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