Premarket (510k) number is unknown.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.Four (4) units were returned for evaluation.Unit 1 and unit 2.Visually inspected on receipt and appears to be assembled correctly.Bags had uci written on bag in black marker and no other markings.Unable to duplicate any failure on this unit as noted in description on complaint.Unit 3 visually inspected on receipt and appears to be assembled correctly.Unable to duplicate any failure on this unit as noted in description on complaint.Unit 4 : visually inspected on receipt and appears to be assembled correctly.Unit was received with uci written on bag, additionally during visual inspection it was noticed the tip of the gauge indicator rod was bent.The root cause unable to be determined for the leak although with the rod tip bent it appears the unit may have had a force applied to the unit after release from production.Unit #4, the reported problem of leaking was duplicated.Unit was leak tested under water and found to leak around the top cap of the gauge assembly.The indicator rod tip was bent and it appeared that the unit may have had a force applied to it after release from production.Root cause unable to be determined.No causes or potential causes to the customer's reported problem were found during the device history record (dhr) review.This remediation mdr was generated under protocol b10009406, as a result of warning letter cms# 617147.
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