This mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).510k is unknown.No information has been provided to date.Udi is unknown.No product information has been provided to date.No lot number was provided; therefore, device history record review could not be completed.One sample returned in used condition and without its original packaging.Visual inspection performed at a distance of 12 inches under normal conditions of illumination and it was observed to have a hole in the tube.During functional testing using the leak test, the leak was detected.The root cause was related to the manufacturing process.A corrective and preventative action has been opened to address the reported issue.As a preventive action manufacturing personnel was notified by the area trainer.
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