One catheter with attached monoject 1.5 cc limited volume syringe and three non-edwards plugs were returned for evaluation.An arrow introducer with non-edwards contamination shield was located on the catheter body between 37.5 cm and 91 cm proximal from the catheter tip.No packaging was returned.No fault messages were observed on the lab vigilance ii monitor when the catheter was connected.The thermistor was found to read 36.9 c when submerged into a 37.0 c water bath.The catheter ran cco in 37.0 c water bath on vigilance ii monitor for 5 minutes without error.The thermistor and thermal filament circuit were continuous, there were no open or intermittent conditions.No visible inconsistency was observed on eeprom data.Resistance value of thermal filament circuit was within specification, measuring 39.52 ohms.Both the thermistor and thermal filament connectors were opened and no visible inconsistencies were found.No visible damage to the catheter body, balloon, or returned syringe was observed.All through lumens were patent without any leakage or occlusion.The balloon inflated clear, concentric and remained inflated for more than 5 minutes without leakage.Balloon inflation test was performed using returned syringe with 1.5 cc air.Visual examination was performed under microscope at 20x magnification and with the unaided eyes.The lot number was not provided; therefore, a review of the manufacturing records could not be completed.The complaint could not be confirmed.No evidence of a manufacturing nonconformance was noted.It could not be determined if procedural factors or device handling may have contributed to the reported event.No actions will be taken at this time.
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