Received one used.List #011-cs25, check valve with male/female luer lock; lot #5600058.As received an axial crack was observed at the female luer of the returned list #011-cs25, check valve with male/female luer lock; lot #5600058.The crack propagated through the gate.The sample was leak tested per product specification.There was a leak at the crack on the used sample.The reported complaint of leakage can be confirmed on the returned one used.List #011-cs25, check valve with male/female luer lock; lot #5600058 due to the crack observed on the sample.The damage observed is typical of an environmental stress cracking during use.The device history review (dhr) for lot 5600058 was reviewed and no non conformities were found that would have led to the reported complaint.
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The event involved a check valve with male/female luer lock where it was reported on the neurosurgical intensive care unit, during a round, a patient was found reactive to the medical care, hypertensive and disconnected from the respirator.The patient should have been sedated.The medical care team observed that the check-valve was cracked and that there was a flow of liquid, as hypnovel, sufentanyl and propofol were flowing on this line.This resulted in unwanted suppression of sedation, rebound of intracranial hypertension with risk of cerebral damages, even death for this patient.The valve was then changed.There was patient involvment and adverse event.Two used devices were returned for investigation and additional information received from the customer stating both these devices were used on the same patient.This captures the second of two occurrences.
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