The actual device was not returned to the manufacturing facility.Therefore, the investigation was based upon evaluation of the user facility information, and retention samples of the involved product/lot number combination.Visual inspection revealed no defects.A review of the lot history files was conducted with no findings.Prior to shipment, qc conducts outgoing visual inspection, sensory inspection and functional testing all samples for the complaint lot passed.The user facility reported a similar event from the same product code/lot number combination.See mdr's 3003902955-2017-00042 and 3003902955-2017-00040.The investigation results verified that the retention sample was the normal product.Without the return of the actual device, the exact cause cannot be definitely determined.(b)(4).
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The user facility reported needle stick injury.The safety needle was used as intended but either the needle pushed through the side of the shield or the needle was just not properly secured in the safety portion causing the tip to push forward and be exposed outside the housing.It was reported that there was no impact on actual patient, who received injection as intended.Additional information was received on 11/7/2017: the hcp activating safety on sg3 post procedure, and was stuck when needle was not secured in as thought.The hcp activated against hard surface (table).Facility protocol followed for post exposure testing, which was negative, and hcp returned to work with no harm.
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