(b)(4).A visual, functional and dimensional inspection of the product involved in the complaint could not be conducted since the product was not returned.No photo available for review.The device history record of the product 031-33j, batch number 74d1500992 has been reviewed and no issues or discrepancies were found which could potentially relate to this complaint.No nonconformance reports were originated for the lot in question that can be associated to the complaint reported.Dhr shows that the product was assembled and inspected according to our specifications.Customer complaint cannot be confirmed due to the lack of device sample to perform a proper investigation and determine the root cause.If the sample becomes available this investigation will be updated with the evaluation results.A capa file # (b)(4) was opened to perform a further investigation this issue ((b)(4)).According to the capa investigation , so far , the root cause for the issue was the positioning of the thread lead and the softness of the new resin used for the snap adaptor.
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(b)(4).The sample was returned for evaluation.A visual exam was performed and it was observed that the internal threads of the adaptor were damaged.Functional testing was performed; however, not all tests were conducted as the adaptor could not be connected correctly on the oxygen supply due to the damaged 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 opened to address this issue.
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