Submit date: 11/21/2016.The device history record was reviewed and indicated that the product was released accomplishing all quality standards.A sample was received for evaluation.A visual inspection was performed and the catheter did not reveal any visual issues.A guide wire was passed through both extensions.The guide wire passed through the arterial extension but it did not pass through the hub of the venous extension.The catheter was cut to inspect the internal channels and the hub was partially obstructed and the orifice looked smaller.A resin was found on the venous lumen.The hub was partially occluded due to an excess of dimethylacetamide during the gluing process.A formal corrective and preventative action was opened and additional actions are not required.It must be noted that in-process controls, according to procedure (such as personnel training, incoming quality acceptance testing for raw material, 100% in process visual inspection and visual acceptance sampling) are in place to prevent non-conforming product from leaving the manufacturing operations.This complaint will be used for tracking and trending purposes.
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