An investigation into the reported condition was performed.Although the complaint report states that a sample has been requested and would be returned no sample has been received at the manufacturing site.Without a sample, we are unable to perform a thorough follow up investigation to include functional and visual evaluation.The reported condition is not confirmed.The review of device history records (dhr) indicates that all acceptance criteria inspections per established sampling levels were within acceptable limits during the production process of the reported lot.A probable root cause of this reported condition may be that the kink was caused during the storage process for the tubes prior to assembly or that the operator coiled the tube incorrectly thus causing a kink or the kink occurred in the tubing during the transport.A definitive root cause of the reported condition could not be determined without a sample.Therefore, a corrective action could not be planned at this time.If a sample should be returned at a later date this complaint will be reopened and the investigation updated to reflect our findings.During the manufacturing of all units, they are all leak tested and functionally tested as a part of the process.Also, independent sampling is complete to confirm units are functioning correctly.Before wrapping and packing, the tube is coiled and covered with a packing cap.If information is provided in the future, a supplemental report will be issued.
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