This follow-up report is submitted to fda in accord with applicable regulations ¿ and as indicated by terumo cardiovascular systems in the initial report submitted to the fda on august 21, 2018.(b)(4).The returned sample was visually inspected, and there was a significant amount of buffer missing from the unit.No other visual anomalies were noted.The unit was pressurized with air (as received), submerged in a water bath, and observed for any leaks.A leak was noted from the large blue luer cap.The large blue cap was then loosened and retightened with a calibrated torque wrench to production specification.The unit was then pressurized with air, submerged in a water bath, and observed for any leaks.A leak was noted from the large blue luer cap at approximately 1000 mmhg.A retention sample from the same lot number was visually inspected and confirmed to have no traces of buffer on the outside of the unit or inside the pouch.The retention sample was then pressurized with air up to 1030 mmhg, submerged in a water bath, and observed for any leaks.No leaks were noted on the retention sample.The complaint was confirmed and the root cause for this event is a lack of sealing between the large bore adapter (blue cap) and the shunt sensor body.When the large blue vent cap is tightened, interference between the threads of the cap and the shunt sensor body exist, causing inadequate seal leading to a leak.All available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.
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