An investigation of the reported condition was performed.The complaint report indicates that no sample was available for evaluation.Without a sample, we are unable to perform a thorough follow up investigation to include functional and visual evaluation to determine the root cause(s) of the reported condition or implement any corrective action(s).Unfortunately, without a sample we are unable to confirm the reported condition.If a sample should be returned at a later date this complaint will be re-opened and the investigation will be updated to reflect our findings.During manufacturing of this product, each unit was functionally tested to ensure it functions properly.Also, independent qa sampling was completed to ensure there are no issues.The device history record (dhr) review showed that all acceptance criteria inspections per established sampling levels were within acceptable limits during the production process of lot.Based on the complaint description the most probable root cause may be that the tube was not assembled correctly or dislodged post production.If information is provided in the future, a supplemental report will be issued.
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