(b)(4).A visual, functional and dimensional inspection of the product involved in the complaint could not be conducted since the device was not returned.No photo available.The device history record of batch numbers 74m1400079 that belongs to catalog #1884 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.Dhr showed that the product was assembled & inspected according to our specifications.A corrective action cannot be applied since it is not possible to identify the defect reported and to investigate its root cause, in order to perform a proper investigation it is necessary to evaluate the sample involved on the incident.Customer complaint cannot be confirmed based only on the information provided.If the device sample becomes available at a later date this complaint will be re-opened.
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(b)(4).The sample received was from a different lot number than what was originally reported by the customer.A device history record (dhr) review was performed on the lot number of the sample received (74f1500151) and there were no issues found that could relate to the reported complaint.No non-conformance reports were originated for the lot in question that can be associated to the complaint reported.The dhr showed that the product was assembled and inspected according to specifications.The customer returned (1) one unit of catalog number 1884 micro mist nebulizer w/tee for analysis.A visual exam was performed and it was observed that there was residue inside the jar, jet, cap, t-connector, and reservoir tube.It was also found that the tube was kinked.Functional testing was performed and no issues were observed.Based on the investigation performed, the reported complaint could not be confirmed.There were no issues found with the returned device.The dhrs were reviewed and no issues or discrepancies were found which could potentially be related to this complaint.
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