Manufacturing device history record review was not performed because the results of the complaint investigation do not indicate a problem with the manufacture of the device.Customer provided the photo showing filter with disconnected luer lock.Each filter contains retention ring which is designed to hold luer lock connected with filter.Due to poor quality of photo, it is not possible to evaluate retention edge on affected filter.Supplier corrective action report (scar) was raised in past against supplier due to similar customer complaints.Based on supplier investigation report, the issue from the past were caused by rotating collar over tightening.As per instructions for use (ifu), overtightening the connection between the epidural catheter connector or needle to the male rotating collar may cause rotating collar to dislodge from filter body.However, for this reported issue no product sample was received for evaluation; therefore, the reported issue could not be confirmed.If the product is returned, the manufacturer will reopen this complaint for further investigation.This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).
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