A review of the device history records shows there were no observations recorded during manufacture to suggest an issue of this nature would occur with this lot of product.A product sample was received for evaluation.Visual and functional testing were performed.The investigation found the rotating collar (luer lock) is missing on returned filter.The issue occurred due to the retention edge on returned sample was found to be damaged and therefore it could not hold rotating collar in place.The probable cause of the reported issue was determined to be related to the user interface.However, a definite root cause could not be determined with the provided information.As per instructions for use (ifu), overtightening the connection between the epidural catheter connector or epidural needle to the male rotating collar may cause rotating collar to dislodge from filter body.Udi is unknown.No information has been provided.This remediation mdr was generated under protocol (b)(4), as a result of warning letter (b)(4).
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