Additional information has been requested but to date has yet to be received.The incident sample has been requested but to date has not been received for evaluation.If the sample is received, or if additional information pertinent to the incident is obtained a follow-up report will be submitted.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.
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The device history record was reviewed and indicated that the product was release accomplishing all quality standards.Upon a visual and functional evaluation of the 15 samples returned for evaluation, the defect was confirmed; leaking was detected between the connection of the tubing line and the cross spike connector.As part of continuous improvements, a corrective action has been opened which includes assembly process changes.These actions are designed to prevent the reoccurrence of the reported defective condition.This complaint will be used for qa tracking and trending purposes.
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