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.Upon visual inspection, there were used decontaminated components which are not part of claimed minipack plus one (1) flat filter was received for investigation without its original packaging.The technician noticed that the 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 user overtightening the connection.Per information for use, "overtightening the connection between the catheter connector or epidural needle to the male rotating collar may cause rotating collar to dislodge from filter body." unique identifier is unknown.No 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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