(b)(4).Method: the complaint opt318 cannula was received at fisher & paykel healthcare (fph) in (b)(4) and was visually inspected.Results: visual inspection of the returned complaint cannula revealed that one flexitube (cannula tubing) was damaged where it connects to the swivel grip.Conclusion: the damage to the flexitube was most likely caused by an excessive pulling force.The hospital also reported that the patient was very active.A cannula with this type of damage would not have passed our visual inspection, nor would it have passed our pressure test.All optiflow junior cannulae are 100% leak and occlusion tested after final assembly and any cannula that fails is discarded.In addition, samples are taken hourly from each run and pull tested to check glue joint strength at the cannula/tube joint, as well as the swivel grip joint.If there are any failures the entire batch is put on hold for investigation.The user instructions illustrate in pictorial format the correct set-up and proper use of the optiflow junior nasal cannula.They also state the following: - ensure that all connections are secure during use.Check cannula is undamaged and that the flow path is maintained.- appropriate monitoring must be used at all times.- do not stretch or crush tube.
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