Event problem and evaluation codes: updated.A device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.Complaint history was reviewed and it was found that there has not been received any customer complaint where leak between connector and tube was confirmed.No product sample nor photos were received; therefore, visual and functional testing could not be performed.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 b10010579, as a result of warning letter cms# (b)(4).
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