Implanted date: device was not implanted.Explanted date: device was not explanted.Based on the results of our investigation the root cause of the complaint could not be identified related to our product or process.The actual sample was not returned for evaluation hence we could not provide detailed information of its actual condition.Retention samples were visually inspected and confirmed free from a bent cannula and defects that will affect activation of safety sheath such as missing tooth, tooth flash, short shot, flash on the sheath, over or under insertion, sheath collar-fitting, and damaged parts that will lead to the complaint.A simulation was also conducted thru aspiration of sterile water, injection to the dummy arm, and manual sheath activation wherein no bending of the needle was encountered that may result in needlestick injury.Lot history files showed no nonconformity or irregularity encountered during the production of the lot.We also have a series of visual in-process inspections from the molding until the boxing process to detect an abnormality on the sheath and collar such as crack, short shot, tooth flash, missing tooth, and damages that may lead to the complaint.Similarly, the assembly status of the safety needle such as sheath collar fitting and damaged parts that will affect product function is being confirmed.Functional tests through safety sheath activation were conducted to confirm that our products are free of defects that would lead to difficulty or failure of device activation.No nonconformity was noted.Furthermore, proper instruction for the usage of the sg2 safety needle device activation including warnings to avoid needle sticks is fully addressed in the instructions for use (ifu) indicated on the unit box.(b)(4).
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