The device history record (dhr) of nl batch number 02l1301299 was received and no issues or discrepancies were found which could potentially be related to this complaint.No non conformance reports were originated for the lot in question that can be associated to the complaint reported.The dhr shows that the product was assembled and inspected according to our specifications.A corrective action cannot be applied since it is not possible to identify the defect reported and to investigate its root cause, in order to perform a proper investigation it is necessary to evaluate the sample involved on the incident.Customer complaint cannot be confirmed based only on the info provided, in order to perform a proper investigation it is necessary to evaluate the sample involved on the incident.However, current production was verified to identify any issue that can lead to the reported defect and no issues were found since wall thickness and internal diameter were found within specification, also a leaking test was performed on these samples on fixture to verify the functionality on the connections and no problems were presented during the performed verification.If the defective sample becomes available, this investigation will be updated with the evaluation results.As a corrective action r&d engineering department will be notified about the complaint received.The lot mentioned in this complaint is related to a resin change project performed (b)(6) 2013.
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