Titan touch pump was received for evaluation.Abrasion was noted on both exhaust tubes and the inlet tube of the pump.A separation, surrounded by abrasion, was noted on the shorter exhaust tube of the pump.This is a site of leakage.Based on examination of the returned product, it was concluded that while in-vivo both the exhaust tubes and inlet tube of the pump had overlapped and abraded against one another.This positioning, in combination with device usage over time, could contribute to sufficient stress to separate the shorter exhaust tubing.A separation 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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