The product sample returned was received within a generic plastic bag and consisted of one 14.5 fr dual lumen hemodialysis catheter with evidence of use.After visual inspection, no defects were identified.During underwater test (functional test) no bubbles were detected.Both lumens, arterial and venous did not show bubbles during the test.More information was requested to the customer and no additional evidence was provided for this analysis.This defect has not been confirmed.With the available information, the most probable root cause for this kind of leak (if the device had been found defective) could be considered as misuse due to over bending or excessive force.It must be noted that in-process controls (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 nonconforming product from leaving the manufacturing operations.Per procedure, manufacturing performs 100% leak testing at the final stage of production, which would identify this issue in the catheter assembly.This complaint will be used for tracking and trending purposes.
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