Implanted date: device was not implanted.Explanted date: device was not explanted.Initial reporter occupation: occupation: rt, rdms.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 and the condition of the sample from the branch cannot be confirmed in the photo.Retention samples were visually confirmed free from defects that will affect the activation of the safety sheath and passed the 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.Similarly, the assembly status of the safety needle such as sheath collar fitting and damaged parts that will affect product function is being confirmed.We have received thirteen (13) complaints covering fy20 to fy22 (september 27, 2022), related to this issue where most of the problems are related to usage particularly due to improper activation of the device (not activating on the hard and flat surface in a quick and firm motion).Based on the investigation of individual complaints there was no attributable cause noted related to our product and production process.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.(b)(4).
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