(b)(4).The customer reported the nebulizer would not nebulize.The customer returned one nebulizer kit which includes a jet, jar, cap, tubing, and mask.The returned sample was visually examined with and without magnification.Visual examination of the returned sample revealed the returned components appear typical with no observed defects or anomalies.Functional testing was performed on the returned sample.6cc of water was added to the returned nebulizer unit and the tubing was connected to an air flowmeter.The inlet pressure was set at 50psi and the flowrate was increased to 8lpm.During functional testing, a mist was produced coming from the chamber.No functional issues were found with the returned sample.The device history record of batch number 74a2001272 has been reviewed and no issues or discrepancies were found which could potentially relate 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.Per the instruction label attached to the finished product, the directions for use instructs the user "if necessary, tap the device until it begins to nebulize".It also instructs the user "during treatment , periodically tap nebulizer to minimize residue volume".The reported complaint of the nebulizer not nebulizing could not be confirmed based on the sample received.During functional testing of the returned sample, the returned nebulizer was able to produce a mist coming from the chamber.A device history record review was performed on product code 1885; lot# 74a2001272 with no evidence to suggest a manufacturing related issue.Therefore, based on the functional testing, no issues were found with the returned sample.No further action is required at this time.
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