Initial reporter phone: (b)(6).The product investigation was completed.Device evaluation details: visual analysis of the returned sample revealed a hole was found in the pebax, and the tip was found bent; no other damage or anomalies were observed on the smart touch unidirectional catheter.The damage could be related to excessive force or to the shipment process a deflection test was performed, and the curve was deflecting within specifications.No deflection issues were observed.The deflection issue reported by the customer could not be replicated during the product investigation; other issues or circumstances may have occurred during the usage of the device that compromised its performance.A manufacturing record evaluation was performed for the finished device number 30699294m, and no internal actions related to the complaint were found during the review.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).
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