Manufacturing and quality control data: the progav component was manufactured in january 2018.There were no deviations during assembly.All parameters (opening pressure, reflux, tightness, adjustability, and break function) were inspected and signed during the manufacturing process.All parameters have been assesses as ok.Investigation: optical inspection: the optical investigation showed that the introduction stylet is bent.Furthermore, it can be seen that the deflector is no longer in the position as at the time of delivery.Result: the obtained ventricular catheter was sent to us in its original packaging and in an opened sterile bag of a progav valve.The deflector has already been adjusted.The real reason why introducing the stylet is bent cannot be clearly established, but the in-process manufacturing controls, guarantee the integrity of the product.All products are 100% performance tested and visually inspected during assembling, packaging and before final packaging.The shunt system was sterilized by miethke and released for shipment and documented as well.A potential mistake at the ventricular catheter would be detected and rejected from the lot.Based on our investigation results, we could not detect any failure with this product at the time of distribution.No capa is necessary.
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