(b)(4).A visual, dimensional, and functional inspection of the device involved in the device could not be conducted since the product or a picture of the defect was not provided at the time of this report.A device history record (dhr) review for the device lot number reported , shows that the device was assembled and inspected according to our specifications.According to the dhr, component p/n mp-0321 was used during assembly.Mp-0321 is the older design of the snap-on flowmeter adaptor, for which capa file #(b)(4) was opened.According to the capa investigation, the root cause for the issue reported was the positioning of the thread lead and the softness of the new resin used for the snap adaptor.Change order form for the design updated approved and dhf has been updated.All production from may 2016 forward is with the updated tfx-001743 snap adaptor component.Capa (b)(4) is currently closed.This customer complaint cannot be confirmed based only on the information received.In order to perform a proper investigation to confirm the alleged defect reported it is necessary to have to device sample.If the device becomes available at a later date, this report will be updated with the investigation results.
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Qn#: (b)(4).The sample was received for evaluation.A visual exam was performed and it was observed that there was damage on the internal thread of the adaptor.This damage is not acceptable according to current specifications.Even with that condition, the sample was able to be tested on the dual station lift test and the general pull and push test procedures.However, it was not possible to perform the oxygen entrainment testing because the adaptor could not be connected properly on the oxygen supply due to the damage on the internal threads.Based on the investigation performed, the reported complaint was confirmed.The root cause for the issue was found to be the positioning of the thread lead and the softness of the new resin used for the snap adaptor.A capa was previously opened to address this issue.The design of the adaptor was updated.All production from may 2016 forward is with the updated snap adaptor component.
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