A device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.Four (4) units were returned for evaluation.They were visually inspected and all 4 units appeared to be assembled correctly.Visually inspected on receipt and appears to be assembled correctly.On units 1,2, and 3, bags have uci written on bag in black marker and no other markings.Functionally tested bag assembly by manually pumping the squeeze bulb and unit performed as required.Functional leak test showed that, for 3 of the 4 units, the reported problem was not duplicated.Unit 4 - 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 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.The root cause unable to be determined.This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms#: 617147.
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