No information has been provided to date.Event problem and evaluation codes: updated.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.The occlusion condition found on returned samples is related to a supplier issue.An awareness meeting with operators and quality inspectors about the failure mode reported on this complaint was held.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 (b)(4), as a result of warning letter cms# 617147.
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