H3.Device evaluation: the device was returned to edwards for evaluation.As received, the luer end of the dilator was broken off and was returned with device.Cross surfaces of broken dilator appeared uneven and rough.Cannula was observed to have multiple kinks along the entire cannula body at the wire-reinforced section.No other visual damage, contamination, or other abnormalities were found.H10.Additional manufacturer narrative: customer report of broken dilator was confirmed.Visual inspections are performed at edwards on opti20 devices during receipt, assembly, and packaging, at which point a broken dilator and a kinked cannular would have been likely noted.It is possible that the damage was the result of the supplier manufacturing process, but it may also have been the result of sub-optimal shipping conditions or use handling during preparation.As reported, the dilator broke during insertion.The package and labeling conditions were not reported.The cause of the broken dilator and kinked cannular could not be determined at this time.Neither an edwards' nor a supplier defect could be confirmed.A definitive root cause could not be identified.
|