Device expiration date: unknown.Device manufacture date: unknown.Investigation summary: one sample was received or quality investigation.The customer complaint of component damage - no leak was not verified by sample investigation.Evaluation of the sample submitted, indicates that the sample tubing separated at the outlet port of the filter and the tubing.Closer inspection of the separation location indicates that the outlet port or the tubing, did not show signs of epoxy at the union site, and therefore easily separated at that location.A device history record review could not be performed on model 11532269 because a lot number was not provided by the customer.The root cause for the issue seen in this complaint is a manufacturing issue.Due to the lack of epoxy applied to the assembly, the infusion set separated at the filter outlet port and tubing.This incident has been added to our database of reported incidents.Our business team regularly reviews the collected data for identification of emerging trends.Investigation conclusion: the root cause for the issue seen in this complaint is a manufacturing issue.Due to the lack of epoxy applied to the assembly, the infusion set separated at the filter outlet port and tubing.
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It was reported that the gem v/nv 20dp ckv 2ss 0.2mf low sorbing experienced device damage while still considered operable.The following information was provided by the initial reporter: rn was changing over iv fluid/ iv tubing per policy, when she was about to connect the new tpn line, noted something had fallen to floor.It was then she noticed that the iv tubing had broken apart at a filter.The connection that broke was not a connection segment that can normally disconnect.
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