Visual and functional inspections were performed on the returned device.The leak was not confirmed.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history of the reported lot revealed no other incidents.The investigation was unable to confirm the reported leak during functional testing of the returned unit.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.
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