Lot number - involved lot number is 102-n2558s was used in the investigation the actual device was not returned to the manufacturing facility for evaluation.Therefore, the investigation was based on the evaluation of user facility information and evaluation of a retention sample from the reported product code/lot number combination.Visual inspection revealed no defects.Functional testing was conducted.Sheath activation and sheath deactivation force of the retention samples were evaluated using the tensile / compression equipment and confirmed to meet manufacturer specification.This shows that the safety needles can be activated with minimum force.Also, when activated, it cannot be easily detached from the sheath tooth.Prior to shipment, qc conducts outgoing visual inspection to assure all lots pass.Without the return of the actual device the exact cause cannot be definitely determined.The user facility reported similar events from the same product code/lot number combination.See mdr 3003902955-2017-00056.(b)(4).
|