(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.Device history record review shows that there were no issues related to functional issues on the corrugated component involved in this complaint (b)(4) (corr-a-flex tubing,100 ft roll) batch (b)(4) during the manufacture of the material.No corrective action can be established at this moment since the device sample or pictures are not available for evaluation.Customer complaint cannot be confirmed based only on the information provided, to perform a proper investigation and determine the source of defect reported it is necessary to evaluate the sample involved in this complaint.If the device sample becomes available at a later date this complaint will be re-opened.
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