The device history record (dhr) is established based on the serial number stick on the device.No serial number (sn) was available, the dhr could not be reviewed.The lot number was not available so the manufacturing date and y port lot could not be tracked.The sample was not available because it was discarded.From the photo provided, it was found that there was a tear in the soft rubber y purple portion of the feeding tube between the two connectors.The manufacturing process of the y-port assembly tests and inspection was reviewed.The leak test was performed following specifications.The leak test can detect a y-port leak issue.The final inspection station has an inspector to check the y-port for cracks.The final inspection station can detect the kind of y-port issue reported as well.All process and controls were found properly followed, including sub-assemblies, finished product assembly, and packaging and inspections performed to the product.There were no abnormal conditions found that could trigger the reported condition.In addition, quality control (qc) inspections were found performed to the product for material release and a 100% visual inspection was performed by the production personnel during the packaging process in order to detect and discard any identified issues.A leak test is conducted as a qc inspection per procedure.From the investigation, the supplier confirmed the production team followed the specification and instructions.The supplier was unable to determine the root cause or the reported issue.No action will be taken at this time.Should a sample become available in the future the complaint will be reopened for further investigation.This complaint will be used for tracking and trending purposes.
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