No lot number was provided; therefore, device history record review could not be completed.A product sample was received for evaluation.Visual and functional testing were performed.The flat filter was returned with the color removed.An observation of the filter connector showed that the height of the return part of the collar attachment was low and collapsed.The root cause of the reported issue was found to be supplier.We notified the occurrence of this event to our manufacturing department and overseas manufacturers and apply improvement.We will also record this event in the database and monitor the future occurrence situation.D4 unique identifier is unknown.No information has been provided to date this remediation mdr was generated under protocol (b)(6), as a result of warning letter cms# 617147.
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