Qn#(b)(4).The customer returned one sealed representative sample of catalog number 1770 nebulizer, large volume, var concentration which consisted of a jar, pickup tube, outlet, entrainment collar, wing nut and an ifu.During the visual inspection, no defects or anomalies were identified.A functional inspection was performed and the wing nut was connected to the oxygen flowmeter.Per the ifu, sterile water was poured into the jar.The entrainment collar was set at 5 lpm, 8 lpm and 10 lpm and the oxygen flowmeter was respectively set at 5 lpm, 8 lpm and 10 lpm.The pressure was increased to 50 psi.During the functional testing, mist was produced from the chamber of the nebulizer.A faint mist was produced at 5 lpm and more visible mist was produced at 8 lpm and 10 lpm.The device history record of batch number 74e1900972 that belongs to catalog number 1770 has been reviewed and no issues or discrepancies were found which could potentially be related to this complaint.No non-conformance reports were originated for the lot in question that can be associated to the complaint reported.The dhr shows that the product was assembled and inspected according to specifications.The reported complaint that the nebulizer did not produce mist was not confirmed during the functional inspection.During the functional inspection, the returned nebulizer produced mist at each setting.An actual sample was not returned for investigation; therefore, the root cause of this investigation is undetermined.
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