Qn#(b)(4).The customer returned a one unit of catalog number 1883 micro mist nebulizer which consists of a corrugated tubing, mouthpiece, tee- connector and tubing.Visual inspection of the returned components revealed that the jet, jar and cap were not returned.The remaining components were visually inspected and no defects or anomalies were observed.Functional testing could not be performed as some of the components were not returned.The device history record of batch number 74k1701030 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.Based on the investigation performed, the reported complaint could not be confirmed.During the visual inspection, it was revealed that a jet, jar and cap were not returned which is required to complete a functional inspection to determine if a mist is produced.Because functional testing could not be performed, the root cause could not be determined.
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