(b)(4).Method: the complaint opt316 cannula was received at fisher & paykel healthcare (fph) in (b)(4) and was visually inspected.Results: visual inspection of the complaint cannula revealed that the flexitube had become disconnected from the swivel grip.Glue was observed to be present on the surfaces of both tubing and swivel grips.Conclusion: an in-depth root cause investigation was carried out to determine the cause of these failures.Our investigation included checking the measured dimensions of each component, a review of production process and production records, a review of operator training records and a review of the standard operating procedure for the cannula assembly process.Our investigations did not lead to a definitive root cause of the swivel grip/tube joint failure.All our testing demonstrated that the assembly and gluing process was operating within specification.No evidence was found to suggest that our manufacturing process was out of specification at any time.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.As part of our ongoing product improvement initiatives, fph has already implemented improved detectability of potential swivel joint failures by increasing the infant optiflow tensile strength testing frequency.This change took effect on september 6, 2016.The complaint device was manufactured prior to implementation of this measure.
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