Investigation.Review dhr inspect returned samples.Analysis and findings complaint (b)(4).Distribution history: this complaint unit was manufactured at csi on 03/07/2019 under wo #(b)(4) and shipped on 09/03/2019.Manufacturing record review: dhr 248286 was reviewed and no non-conformities, related to the complaint condition, were noted.Incoming inspection review: not applicable.Service history record: no additional service history records found for this unit.Historical complaint review: a review of the 2-year complaint history showed similar reported complaint condition.Product receipt: the complaint unit was returned on a repair.Visual evaluation: visual examination of the complaint unit revealed physical damage with a bent nozzle and a broken off luer lock.Functional evaluation: complaint unit was functionally evaluated and found not to function properly.Service & repair confirmed the complaint unit also had a partially blocked valve.Root cause: the damage is due to handling error by the end user.The blockage in the main valve is also deemed as an end user handling error.This device is to be filled with liquid nitrogen from a clean source.Typically, dewars are used to refill the bottle which must be kept clean as any particulate will be transferred to the bottle and taken up by the feed tube on this device.Corrective actions the unit was repaired, cleaned, tested and returned to the customer.Coopersurgical will continue to monitor this complaint condition for trends.No further corrective action is necessary.No further training required.*was the complaint confirmed? yes.
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