(b)(4).Method: the complaint ojr416 optiflow junior 2 nasal cannula was received at fisher & paykel healthcare (f&p) new zealand, where it was visually inspected.Results: visual inspection of the complaint cannula confirmed that the tube was broken near the hub.Conclusion: we are unable to determine the cause of the reported event.However, it is most likely caused by the tube being inadvertently pulled.All optiflow junior cannulas are 100% leak and occlusion tested after final assembly and any cannula that fails is discarded.Samples are also taken and pull tested to check the tube tensile strength and the glue joint strength at the cannula/tube joint, as well as the swivel grip joint.The subject cannula would have met the required specification at time of production.The user instructions illustrate in pictorial format the correct set-up and proper use of the optiflow junior 2 nasal cannula.They also state the following: - appropriate patient monitoring (e.G.Oxygen saturation) must be used at all times.Failure to monitor the patient (e.G.In the event of an interruption to gas flow) may result in serious harm or death.- do not wrap, insulate, stretch or crush the tubing as this may impair the performance of this product or compromise safety (including potentially causing patient harm).- ensure all connections are secure during use.Check the cannula is undamaged and that the flow path is maintained.Under excessive load, the cannula may disconnect to prevent forces being transferred to the patient.- ensure the patient does not lie on the tubing as this may apply pressure to the patient's ears or face.- failure to apply and use this product within the directions, transport, storage and operating conditions specified in the labeling and user instructions may impair performance of this product or compromise safety (including potentially causing serious patient.
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