The sample was returned from the customer for evaluation.When observing the male connector of the filter, it was confirmed that the retention edge which is designed to hold rotating collar connected with filter was damaged.As a result of the investigation, it was confirmed that the retortion edge was damaged and flattened, and it is possible that this event was caused.The timing of the collapse of the retortion edge and the cause of the reported event could not be identified.The occurrence of this event will be notified to our manufacturing department and this event will be recorded in the database to monitor the future occurrence.Device history record review of manufacturing records, relevant to the lot reported, found no discrepancies or anomalies.(b)(4).
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