Implanted date: device was not implanted.Explanted date: device was not explanted.The actual device was not returned however six pieces unused same lot samples were returned.As stated on the complaint details, the health care professionals were attempting to activate the needle using their finger.Most likely, the sheath did not fully activate that have caused needle stick.It is stated on the instruction for use that the activation must be done on a hard and flat surface in a quick and firm motion.Retention samples and six returned unused same lot samples were visually confirmed free from defects that will affect activation of safety sheath and passed the functional evaluation for sheath activation and deactivation.We have 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 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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