D4: udi - not required for the reported product code/lot number combination.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.Sheath activation test verified the retention samples passes specification.Manual activation was performed and all samples were successfully activated without difficulty.A review of the lot history files was conducted with no relevant findings.Prior to shipment, qc conducts outgoing visual inspection, sensory inspections, and functional testing and all samples for the complaint lot passed.The user facility reported a similar event from the same product code/lot number combination.See mdr 3003902955-2017-00030.There is no evidence that this event was related to a device defect or malfunction.Without the return of the actual device the exact cause cannot be definitely determined.Terumo medical products (tmp) (importer) registration no.2243441 is submitting this report on behalf of terumo (philippines) corporation (manufacturer) registration no.3003902955.Exemption number e2015017.All available information has been placed on file in quality assurance for appropriate tracking, trending and follow up.
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The user facility reported needle sticks.The following information was provided by the user facility: our company has started using the terumo suirguard3 needles and the staff needs some education on the use of these needles especially our pediatrics department; they have had some needle sticks since using this product; and there were no other devices or equipment being used with the reported product.Additional information was received on august 1, 2017.The clinicians had needle sticks with sg3-2516.Both needle stick occurrences were from thumb activations and both did not fully engage/activate all the way, and in both instances the needle was sticking out of the sheath.When the clinicians grabbed the safety needle to discard it they held it up by the sheath/needle and got stuck by the needle.The patients were not affected, and there are not any health concerns for the clinicians.
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