Lot expiration and create date for this device are not available at this time.Report source foreign: (b)(6).Device evaluation: one flat filter and epifuse connector was returned for investigation.Immediate visual inspection detected that the flat filer was not passed and the epifuse connector was locked.A stock catheter was connected to the flat filter and epifuse connector to test for a leak, but no leakage was found.In addition, the inner and outer diameters of each connector were checked using an inspection gauge, but all the connectors were found to have conformed to the standard, and no abnormalities were found.Additionally, the device history record was reviewed and showed that this device met all manufacturing specification for product released for distribution.No issues were identified that would have impacted this event.Based on the evaluation and testing, the complaint was not confirmed.No fault was found with the returned sample.
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