The device was not returned for evaluation.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 identified no other similar incidents and/or complaints from this lot.Based on the information provided, a conclusive cause for the reported leak could not be determined.It may be possible that the inflation device was not properly connected to the sidearm; however, without having the device to examine, a conclusive cause could not be determined.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.
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