Evaluation summary: (b)(4).It was reported that a foreign material was found in a coolflow tubing set when priming was started after the tubing set was taken out from the package.The issue was resolved by changing the tubing set.The procedure was completed without patient consequence.Upon receipt, the tubing was visually inspected and the joint between male luer stem and pvc tubing had some white spots in the adhesive joint.In addition, adhesive like material was found near the valve of the tubing.However, no solid foreign material was observed.Based on the initial investigation it was confirmed that the white spots are adhesive and it is related with the tubing manufacturing.An internal corrective action was opened to investigate this issue.The device history record (dhr) was reviewed and no anomalies were found related to this complaint.In addition, the dhr review verifies that the device was manufactured in accordance with documented specification and procedures.The customer complaint has been verified.However the root cause remains unknown.An internal corrective action was opened to investigate this issue.
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