(b)(3).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 investigation did not show issues related to complaint.A document assessment was conducted and no changes required.Corrective actions cannot be established since it is necessary to receive the physical sample to perform a proper investigation and confirm the alleged defect.At this time the sample is not available and it is not possible to determine the source of the defect reported.Customer complaint cannot be confirmed due to the lack of product sample not available to perform a proper investigation and determine the root cause.If the device samples become available at a later date, this complaint will be updated accordingly.Teleflex will continue to monitor and trend on similar complaints.
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(b)(4).The sample was returned for evaluation.A visual exam was performed and no issues were observed.Functional testing was also performed and the unit passed two of the functional tests, however, the current test was not able to be conducted as an open circuit was detected and the unit did not heat up.Based on the investigation performed, the reported complaint was confirmed.Although the complaint was confirmed, a root cause for the issue could not be determined.All aquatherm heaters are 100% tested at the manufacturing facility; therefore, it is unlikely that this occurred during manufacturing.A defect of this type would have been detected during the final inspection test.A conclusion code could not be chosen as the complaint was confirmed; however, a root cause was not established.
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