Device code 2017- incorrect contrast.Visual, dimensional and functional analysis was performed on the returned device.The reported deflation issue was not confirmed.It should be noted that the armada 35 instruction for use, instructs to use 60% contrast diluted 1:1 with normal saline.In this case, it could not be determined if the contrast ratio contributed to the deflation difficulty as the contrast was mixed 5ml contrast to 10ml serum.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 indication of a lot specific product quality issue.The investigation was unable to determine a cause for the reported deflation issue.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.
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