(b)(4).Method: the two complaint opt318 cannulae were received at fisher & paykel healthcare and were visually inspected.A third unsealed and undamaged cannula was received.An additional 30 sealed, unused cannulae were received.The unused samples were visually inspected and submitted to tensile strength testing to check the retention of the tubing in the swivel grip.Results: visual inspection of the two complaint cannulae revealed that in one case one of the flexitubes had become disconnected from the swivel grip and in the other case both tubes were detached from the swivel grip.A small amount of glue was present on the surfaces of both tubing and swivel grips.Visual inspection of the 30 unused cannulae showed that there was no visible damage or defect with any of them.All 30 were pull tested and the joint strength was found to be within specification, with no detaching of the tubing from the swivel grip.Conclusion: we were unable to determine what had caused the observed damage.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 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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