Titan touch pump, cylinders 1 and 2, and reservoir were received for evaluation.Abrasion was noted on both exhaust tubes and the inlet tube of the pump.Two separations, surrounded by abrasion, were noted on both exhaust tubes of the pump.These were sites of leakage.No functional abnormalities were noted with cylinder 1 or cylinder 2.No functional abnormalities were noted with the reservoir.Based on examination of the returned product, it was concluded that the abrasion marks noted on both exhaust tubes and inlet tube of the pump matched in such a way to conclude that they had overlapped and abraded against one another while in-vivo enough to cause the separations.Separations of this type could then allow the loss of fluid, making the device inoperable.A review of the device history record confirmed the devices from this lot met all specifications prior to release.A review of the complaint history database, nonconformances and capas revealed no trends for this lot.
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