The unit was received and inspected.The yellow cap was pulled of the flanged connector without any difficulty.There is moderate resistance by design as the yellow cap could fall off otherwise.A review of the device history records shows that this lot of chest drains met all requirements including the incoming inspection records for the tube sets that contain the yellow caps.Based on the details of the complaint and analysis of the returned product, the connectors were able to be removed without difficulty, therefore atrium could not find any fault with returned unit.Clinical evaluation: the oasis chest drain system is indicated for the evacuation of air and/or fluid from the chest cavity or mediastinum and to help re-establish lung expansion and restore breathing dynamics.It also facilitates postoperative collection and reinfusion of autologous blood from the patient¿s pleural cavity or mediastinal area.If the clinician has difficulty in the setup of the drain it could potentially represent a delay in treatment for the patient.Clinical education and comprehension is imperative to the success in the setup of a chest drainage system and the delivery of the necessary therapy.The product is labeled so that a practitioner is properly informed of the intended use and indications of the device.
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