H6: event problem and evaluation codes: updated.E4 is unknown.No information has been provided to date.H10: device evaluation: two sample was returned for investigation.The samples were received in used condition without the original package.Returned samples were tested for water leak; returned samples exhibited occlusion condition.The samples were also visually inspected under a microscope to detect the cause of obstruction.It was observed that the internal diameter of the tube was obstructed.A process verification was conducted where the returned samples were placed on the fixture.No bubbles were observed on the fixture.It was concluded that the operator did not use the fixture properly to identify the occlusion, as it was corroborated that the fixture detects occlusion defect.For corrective action, a reinforcement of the process/procedures was stressed to operators of the area.An awareness meeting with operators and quality inspectors about the failure mode reported on this complaint was also held.The source of the related problem was traced to the supplier.Device history record dhr was performed, and no issues or deviations were observed during the manufacturing of this lot.An internal scar has been opened and this issue will be monitored for any increase in occurrence.If the occurrence of this issue increases significantly, additional corrective actions will be taken.This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).
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