Visual inspection upon receipt found that the cap had been removed from the blood outlet port and the blood outlet port had been crushed inward from the outside.The cap was returned along with the device.The cap was inspected with the naked eye and under magnification.It was found to have some deformed portions on the surface.The blood outlet port on an oxygenator sample, with the cap attached to it, was hit on a hard object.As the result, the cap and the blood outlet port got deformed into the configurations which were similar to those observed on the actual sample.There is no evidence that this event was related to a device defect or malfunction.Based on the investigation result, it is likely that the actual sample was exposed to some hitting force on the blood outlet port on the oxygenator module, resulting in the reported damage.The exact cause of the reported event cannot be definitively determined based on the available information.
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