Other, other text: h6: event problem and evaluation codes: updated.H10: a device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.No product sample was received for evaluation.One (1) picture was attached and reviewed.Visual inspection found an admin set with the filter installed backward, next to the set is the pouch with label and the statement arrow should be pointing the other direction.Arrows on each side of filter also point to incorrect direction (not seen in picture)." the reported failure mode is confirmed.Event occurred at distributor, the root cause of the issue could not be determined.If the product is returned, we will reopen this complaint for further investigation.This issue will be monitored for any increase in occurrence.If the occurrence of this issue increases significantly, additional investigative action will be taken accordingly.This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).
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