A device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.Four (4) used decontaminated filters, three (3) used decontaminated connectors and one (1) unopened unit pack samples were received for evaluation.Visual and functional testing were performed.Under visual inspection for used samples, the technician noticed that the rotating collars (luer locks) on flat filters are missing on 3 out of 4 returned filters, 1 rotating collar was still connected with connector.Each flat filter contains retention edge which is designed to hold rotating collar connected with filter.Retention edges on 3 returned samples were found to be damaged and therefore they could not hold rotating collars in place.One flat filter with rotating collar was assembled 10 times with received connectors without any problem.Visual inspection for the unused sample, appeared to be in good condition.Retention ring and luer lock hole diameters were measured under keyence camera system with purpose to find out if there is any dimensional issue which might lead to this customer complaint.Both dimensions were found to be within specifications.The root cause of the reported issue was found to be caused by the user overtightening rotating collar and a supplier corrective action report (scar) was raised in the past against the supplier due to similar customer complaints.Per instructions for use "overtightening the connection between the catheter connector or needle to the male rotating collar may cause rotating collar to dislodge from filter bod.No information has been provided to date.This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# 617147.
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