This follow-up report is submitted to fda in accord with applicable regulations.(b)(4).The sample was returned for evaluation.Buffer solution was present within the returned devices, although it appeared to be less than the normal observed retention sample level within each unit.No other visual anomalies were noted.The units were separately pressurized with air (as received) up to 1030 mmhg, submerged in a water bath, and observed for any leaks.No leaks were noted within either device.The large blue cap was then loosened and retightened with a calibrated torque wrench to production specification for each unit.Each 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 300 mmhg and 430 mmhg, respectively.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, submerged in a water bath, and observed for any leaks.No leaks were noted on the retention sample.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.
|