A device history record review could not be performed because the serial and lot numbers were not received with the complaint.However, as part of our manufacturing process, all device history records are reviewed and approved by quality, prior to the release of product.The manufacturing process was reviewed, and no issues were identified.All tubes are subjected to both a leak test and final cosmetic inspection to check for any y-port issues, and there have been no cracked or detached y-ports identified during this process over the past 12 months.In addition, raw components were inspected, and the issue reported was not present in any of the raw components reviewed.One sample was received for the investigation.The sample was evaluated, and the reported issue was confirmed; the sample arrived with the y-port completely broken in half.However, when trying to remove the transparent connector for further evaluation, it could not be removed, the connection was too tight.The overtightening of the connection could not be related to the manufacturing process or deemed a quality issue.The evaluation of the sample determined that the root cause of this issue was inappropriate use of the device.A corrective action is not applicable at this time.Functional testing and visual inspections are being performed according to our current quality standards and inspection procedures.We will continue monitoring the process for any adverse trends that require immediate attention.This complaint will be used for tracking and trending purposes.
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