The device was not returned for analysis.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 did not indicate a lot specific quality issue.It is possible that the devices were not properly aligned and/or not fully connected/tightened while attempting to connect resulting in the reported loose/intermittent connection and ultimately resulting in the reported leak; however, as the device was not returned for analysis this cannot be confirmed.The investigation was unable to determine a conclusive cause for the reported loose/intermittent connection and the reported leak.There is no indication of a product quality issue with respect to manufacture, design or labeling.The additional 20/30 priority pack indeflator device referenced in b5 is filed under separate medwatch report number.
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