The returned sample was visually inspected and found to be non conforming orange/brown foreign material on the port face, welded cap, and needle near welded cap.The sample was then functionally tested for actuation and cut and was found to be conforming for both functional tests.The product was processed and released according to the product¿s acceptance criteria.The returned sample was found to be functionally conforming, therefore an actuation failure as described in the complaint was not confirmed and a root cause cannot be determined for the complaint as described by the customer.No action was taken as the returned probe was functionally conforming.All probes are 100% visually inspected and tested for actuation, aspiration, and cut during manufacturing.Any non-conformances found are removed from the lot and scrapped.Complaints are reviewed and monitored at regular intervals for any significant adverse trends.No adverse trends have been observed associated with the reported product and event.No further actions are required.The manufacturer internal reference number is: (b)(4).
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