A device history record review could not be performed because the serial number was 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.One physical sample was received at our decontamination lab.However, the used sample could not be forwarded to the manufacturing site for physical evaluation due to current customs policies.As a result, photos were instead taken of the sample by the decontamination lab and provided to the manufacturing site to aid the investigation.Upon a visual evaluation of the photos, the reported issue was confirmed; a detached component was observed.The manufacturing process of the y-port assembly, test, and inspection was reviewed and found that all tubes have been 100% tested and inspected.Tubes that fail at any station are not packaged.A leak station detects any y-port assembly issues such as breaks and leaks, but no assembly issues have been found over the past 12 months.An fni station pulls and inspects the y-port assembly quality but no y-port cracks have been found during the manufacturing process.In addition, the same failure could not be observed on raw components.Based on all available information the root cause could not be determined at this time.However, if additional information becomes available or the sample is received by the manufacturing site, the investigation will be updated accordingly.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.This complaint will be used for tracking and trending purposes.
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