The device was returned to the factory for eval.It showed no signs of clinical usage or evidence of blood.The delivery device was returned outside the loading device.The tension spring assembly, seal and anchor were inside the loading device.The blue slide lock was locked and the white plunger was not depressed on the delivery device.Based upon the received condition of the device, the reported complaint was confirmed for fail to load.A lot history record review was completed for the reported product lot number.There was no non-conformance recorded in the lot history.Internal corrective action (wy-2013-35) issued for this failure mode.(b)(4).
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