This ocean water seal chest drain product code/ref number 2002-400 uses a pre-filled water ampoule for set-up as opposed to a pre-attached funnel for set-up available in all other ocean drain configurations. Visual Iconic set-up instructions were added in the form of an image in 2019 on all ocean drain packaging (on the back of each drain) demonstrating use of a pre-attached funnel, which does not show the user how to fill the ocean water seal chest drain (set-up step) with the use of the supplied water ampoule packaged with the ocean water seal chest drain, product code/ref number 2002-400. However, the instructions for use (ifu) packaged with each case of six (6) ocean water seal chest drains, product code/ref number 2002-400, does include instructions for set up in both drain configurations. The mismatch between the iconic set-up instructions (funnel technique shown only) and the instructions for use (which contains instructions for both the funnel and ampule technique) created confusion to the user. As a result, the user did not fill the water seal chamber using the sterile water ampoule provided with the drain. With the water seal chamber not having the necessary fluid, the one-way valve to protect the patient was not established and the pleural space was exposed to atmospheric pressure. The improper set up of the atrium ocean water seal chest drain, product code/ref number 2002-400, could potentially cause delay in treatment or potential harm to the patient. The chest drain attached to the patient for prescribed thoracic drainage therapy must be a 'closed system', thus it requires the establishment of the water seal to protect the patient from atmospheric pressures. Without the necessary closed system, the air within the drain cannot be removed and the risk of a Pneumothorax is established. Recall date: 2021-10-26
RecallTracker