This follow-up report is submitted to fda in accord with applicable regulations.The returned sample was visually inspected, and no noted anomalies on the sample.It was leak tested by connecting with the calibrated manometer, submerged into a water bath, pressurized up to 1030 mmhg, and no leaks were noted.The large blue cap was then retightened with a calibrated torque wrench to production specification.The unit was then pressurized with air, submerged into a water bath, and pressurized up to 1030 mmhg, and no leaks were 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 also leak tested, 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.
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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 december 21,2018.(b)(4).All available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.
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