(b)(4).Method: three rt380 adult dual heated evaqua2 breathing circuits (two in sealed and one in an unsealed packaging bags) were returned to fph in (b)(4) and were visually inspected.Results: no physical damage was observed to the adult breathing circuits that were returned in sealed packaging bags.However, both the inspiratory and the expiratory limbs of the breathing circuit in an unsealed packaging bag had a cut in the tubings.The tubings appeared to have been cut with a sharp object.A lot check revealed no other complaints of this nature for lot number 150609.Conclusion: from the appearance and location of the damage to the tubings, we can conclude that the cuts were most likely caused by opening the box or packaging bags with a knife or box cutter.All rt380 adult breathing circuits are visually inspected and pressure tested for leaks prior to distribution.Any breathing circuit which does not pass the pressure test is discarded.The subject rt380 adult breathing circuit would have met the required specification at the time of production.This suggests that the affected breathing circuit was damaged post production.The user instructions that accompany the rt380 adult dual heated evaqua2 breathing circuit state the following: "check all connections are tight before use."; "perform a pressure and leak test on the breathing system and check for occlusions before connecting to a patient."; "set appropriate ventilator alarm.".
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