We received one 782hf75 catheter with an attached monoject 3ml syringe with 1.5 ml limited volume for examination.The thermistor was submerged in a 37.0c water bath and read 36.9c on the vigilance ii monitor.Thermistor temperature reading accuracy is +/- 0.3c per the vigilance manual.The thermistor was continuous with no open or intermittent conditions.The thermistor connector was opened and no visible inconsistencies were found.All through lumens were patent without any leakage or occlusion.The balloon inflated clear, concentric, and remained inflated for 5 minutes without leakage.No visual damage, contamination, or other abnormalities were found on catheter and syringe.A review of the manufacturing records indicated that the product met specifications upon release.The reported event was not confirmed.Although the cause of the complaint could not be determined, there was no indication of a manufacturing defect noted during the analysis.No actions will be taken at this time.
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