The device was not returned for evaluation.A review of the complaint history identified no other similar incidents reported from this lot.The investigation was unable to determine a cause for the reported difficulty.It may be possible that the threads on the y-connector or sidearm became damaged resulting in a loose connection and observed leak; however, without having the device to examine, this could not be confirmed.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.
|