Udi number is not required for the reported device.Device manufacturer date - 06/23/2017 thru 06/27/2017.The actual device was not returned for evaluation.Therefore, the investigation was limited to three retention samples from the reported product code/lot number combination.The inner-needle was closely examined by withdrawing it from the catheter in a straight backward motion.As a result, it was confirmed the safety cover was properly able to shield the tip of inner-needle as intended.A review of the manufacturer inspection records was conducted with no findings.Visual inspection conducted after the product assembly also showed no product with defective activation of the safety-cover.Furthermore, there has been no similar incidents ever reported for the concerned lot by other medical institution.The retention samples were the normal product.With no device return the exact cause of the reported event cannot be definitively determined.The device labeling does address the potential for such an event in the instructions-for-use (ifu) with statements such as the following: do not grasp at the junction of hub and tip of the safety mechanism to disconnect.To assure activation of safety mechanism; withdraw the inner needle with care while avoiding an extreme angle or rotating motion.(b)(4).All available information has been placed on file in quality assurance for tracking, trending, and follow up.
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