A device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.A product sample was received for evaluation.Visual and functional testing were performed.Under visual inspection we noticed that rotating collar (luer lock) is missing on returned filter.Each flat filter contains retention edge which is designed to hold rotating collar connected with filter.Retention edge on returned sample was found to be damaged and therefore it could not hold rotating collar in place.The root cause of the reported issue was found to be an issue with the user interface.Model # is unknown.No product information has been provided to date.This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).
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