A decontaminated sample was received at the plant for the investigation.A review of the device history record could not be conducted because a lot number was not provided.Upon a visual evaluation of the sample, the defect was confirmed; the tube was observed to be kinked.A root cause could not be determined.As part of continuous improvements, a corrective action has been opened to implement effective solutions to prevent the reoccurrence of the reported condition.This complaint will be used for tracking and trending purposes.If information is provided in the future, a supplemental report will be issued.
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