We received one 744hf75 catheters with (1) attached monoject 3ml syringe with 1.5 ml limited volume for examination.The balloon inflated clear, concentric and remained inflated for 5 minutes without leakage.No resistance was felt during injecting air.No visible damage or deterioration was found from the balloon latex and balloon bonding sites.The balloon deflated without the syringe attached.All through lumens were patent without any leakage or occlusion.No visible damage was observed from catheter and syringe.Per the ifu, passively deflate the balloon by removing the syringe from the gate valve.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.A review of the manufacturing records indicated that the product met specifications upon release.
|