A review of the device history records was performed for the indicated packaging and component lots for any deviations related to the reported defect of the complaint.The review confirms that the lots met all material, assembly and performance specifications.The recent angiodynamics complaint report was reviewed for the bioflo dialysis product family and the failure mode "extension leg - detached/separated/fractured".No adverse trend was indicated.It was noted during the visual inspection of the returned catheter that there was a hole just below the female luer {red clamp side}.The reported complaint device failure mode of "leakage" was confirmed.A hole was observed in the arterial extension tube adjacent to the flat section of the hub, i.E.90° from the parting line.Although the damage to the catheter was confirmed, there are no visible indications that the failure is related to either the manufacturing process or associated tooling.The exact root cause is unknown, however, a potential root cause for this failure is the end user over-torquing the hub-to-extension tubing junction during cleaning/use of the device.((b)(4)).
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