(b)(4).One (1) unit of fg 031-33j "nebulizer adaptor 033, sterile, japanese" was received for analysis.Signs of use are observed since a disinfection tag is present and the sample was not received on its original package.Also, during visual inspection it was observed that component p/n tfx-001743 doesn't spin freely.No other issues were found.Sample was tested on oxygen entrainment test (tp-0041 rev.26) and during the setup it was observed that the assembly of the nut adaptor component p/n tfx-001743 and the upper body component p/n mp-0527 was unstable.Even with that condition, the sample was able to be tested on oxygen entrainment testing (tp-0041 revision 26) but the testing failed due such condition.After the testing finished, the component p/n tfx-001743 was carefully disassembled from the component upper body mp-0527 and it was visually inspected.During the visual inspection it was found wear on its internal tabs.The device history record of batch number 74g1801777 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.Dhr shows that the product was assembled & inspected according to our specifications.Based on the additional inspection on the component tfx-001743 of the sample received, the complaint is confirmed.Although the condition observed on the sample provided, there is no sufficient evidence to assure that this issue was originated during the manufacturing assembly or molding process.The wear on the internal tabs of component tfx-001743 most likely be caused by the end user during the connection of the adaptor into the flowmeter that causes an unstable connection issue.Based on previous statements it is not possible to establish a corrective action.
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