(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.The device history record of the product 031-33j batch number 74e1601942 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.No conclusion can be established at this time based on the lack of device sample.If the device sample becomes available this complaint will be reopened.Customer complaint cannot be confirmed due to the lack of device sample to perform a proper investigation and determine the root cause.If the device sample becomes available this investigation will be updated with the evaluation results.The personnel of the assembly line were notified for awareness of this issue.
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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.The damage on the internal thread of the component is not acceptable according to the current specifications.However, even with that condition, the sample was able to be tested on dual station lift test and general pull and push test procedures.However, it was not possible to perform the oxygen entrainment testing because the adaptor could not be connected correctly on the oxygen supply due to the damage on the internal thread.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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