Implanted date: device was not implanted.Explanted date: device was not explanted.Health professional: rn.The root cause of the complaint could not be identified to be related to our production or process.The actual sample was not available for our evaluation.Retention samples were visually confirmed free from defects that will affect activation of safety sheath and passed evaluation for sheath activation and deactivation.Also, no irregularity was encountered during the simulation of manual sheath activation that may lead to the complaint.We have a series of visual in-process inspections to detect an abnormality on the sheath that may lead to a problem during sheath activation.The molding condition of the components critical to the safety activation of the product is routinely checked to assure that no defects will be encountered that will lead to sheath activation problems and needle sticks.Similarly, the assembly status of the safety needle such as sheath collar fitting and damaged parts that will affect product function is being confirmed.Lot history file revealed no related nonconformity or irregularity that will lead to the complaint.Prior to shipment, qc conducts outgoing visual, sensory, and functional inspections to assure lots are of good quality.Therefore, we advise to follow the instructions for use (ifu) for the proper usage of the sg2 needle indicated on the unit box in which warnings to prevent needle stick, cautions, and precautions are also included.Terumo medical products (tmp) (importer) registration no.(b)(4) is submitting this report on behalf of terumo ((b)(4)) corporation (manufacturer) registration no.(b)(4).
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The user facility reported that the safety engagement malfunction led to a needle stick.The staff member thought the safety was engaged; however, it was not.Additional information was received on 31 mar 2022: the reported product was used for a patient injection.When the staff member attempted to engage the safety, they thought they heard the click, as intended for successful containment of needle into sheath.The staff member incurred a needle stick because the device was not engaged, and the exposed needle stuck them.The needle stick injury did not require medical intervention.A simple first aid wash/band-aid was applied.The patient in the procedure room was not impacted in any way.
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