Our product evaluation lab received one 777f8 with monoject limited volume syringe.The balloon did not inflate due to a tear, approximately 0.04-inch length, at the distal end of proximal balloon bond.The edges of latex did not appear to match at the torn location.All through lumens were patent without any leakage or occlusion.No other visible damage or abnormality was observed from catheter body.A device history record review was initiated to assess that the device met all specifications upon distribution.Report of balloon not inflating was confirmed.An engineering evaluation has been initiated to assess for any manufacturing-related processes which could be correlated to the complaint.A supplemental report will be submitted if there are any findings.Complaint histories for all reported events are reviewed against trending control limits, and any excursions above the control limits are assessed and documented as part of this monthly review.
|