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 october 8, 2018.All available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.
|
This follow-up report is submitted to fda in accord with applicable regulations.(b)(4).The returned sample was visually inspected with no anomalies noted.The unit was pressurized with air (as received) up to 1030 mmhg, submerged in a water bath, and no leak was noted.The large blue cap was then loosened and retightened with a calibrated torque wrench to production specification, it was then pressurized with air, submerged in a water bath.No leak was noted.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.It was then pressurized with air, submerged in a water bath, and no leaks were noted.The complaint was not confirmed, and a definitive root cause was not able to be determined.It is possible that the buffer solution was not completely wiped off the product after buffer fill during manufacturing.All available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.
|