Additional information provided in d.9., h.3., h.6., and h.10.Two opened probes were received.At the time of receipt it was observed that the probe without the tip protector was bent at the stiffener.Sample #1 was visually inspected and found to be non-conforming with orange/brown foreign material on the port face.The sample was then functionally tested for actuation, aspiration, and cut and was found to be conforming for all three tests with no noise observed.Sample #2 was visually inspected and found to be non-conforming with orange/brown foreign material on the port face and the probe needle and inner cutter bent and cracked, confirming the received condition of the probe.Functional testing, disassembly activities, and a wear evaluation were unable to be performed due to the visual condition of the probe.A review of the device history record traceable to the reported lot number indicates that the product was processed and released according to the product¿s acceptance criteria.The complaint evaluation indicated that sample #1 was functionally conforming with no noise observed.Sample #2 was received with the needle and cutter bent and cracked.Therefore, a confirmation of the reported event could not be determined and the exact root cause of the complaint could not be verified.The exact root cause of the bent and cracked needle and cutter cannot be determined from this evaluation.The most likely root cause is handling at any point after the probe was shipped from the manufacturing site.Confirmation of the reported event could not be determined and an exact root cause for the bent/cracked needle could not be verified, therefore, no specific action with regard to this complaint was taken.Probes are 100% visually inspected and tested for actuation, aspiration, and cut during manufacturing.Any non-conformance's found are removed from the lot and scrapped.The manufacturer internal reference number is: (b)(4).
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