(b)(4).Method: the complaint opt318 cannula was received at our regional office in (b)(4) and was visually inspected.Our investigation is based on photographs provided by our office.Results: photographic inspection revealed damage at the swivel grip.The metal spring was stretched near the swivel grip, but was still intact and attached to the swivel grip.Conclusion: the damage to the flexitube was most likely caused by an excessive pulling force.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: - do not stretch or crush tube.- 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.
|