(b)(4).Method: the complaint opt544 cannula was received for evaluation and was visually inspected.Results: the cannula appeared well used.The visual inspection revealed that the tubing was torn and stretched along its entire length.The cannula had also been pulled off the right side of the manifold.Conclusion: the most likely cause of the reported fault is the patient or caregiver pulling on the tube.The condition of the tube indicates that excessive pulling force has been used and caused gross damage to the cannula.Our user instructions that accompany the opt544 illustrate the procedure for fitting the optiflow nasal cannula to a patient and state the following: do not crush or stretch tube.The opt544 interface is shipped to the customer fully assembled.The cannula is 100% inspected by production line staff during assembly for visual defects such as cracks, tears, inclusions, discolouration and deformation.If any are found the product is discarded.
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