(b)(4).Method: the complaint op318 cannula was returned to fisher & paykel healthcare for evaluation and was visually inspected.Results: visual inspection of the returned cannula revealed that both flexitubes (cannula tubing) were damaged where they connect to the breathing circuit.The tubing was stretched and broken but the metal spring was still attached.Conclusion: we were unable to determine what had caused the damage to the flexitubes, but it was likely caused by excess pulling force being exerted on the tubing.All optiflow junior cannulae are 100% leak and occlusion tested after final assembly and any cannula that fails is discarded.In addition, samples are currently 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 aside for further 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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