The following fields were updated due to additional information: d10: device available for eval yes.D10: returned to manufacturer on: 2021-12-08.Investigation summary: five photos and four samples, one used and three representative samples, were received by our quality team for evaluation.All five photos show the kinked catheter.The used sample, which was returned in a rubber glove, was subjected to visual inspection.Two kinks were observed on the used catheter tubing.One kink is approximately 1 cm away from the nose of the housing and the second is near the nose of the housing.The representative samples were visually inspected on the catheter tubing before and after removing the cannula from the catheter near the nose of the housing and approximately 1 cm away from the nose of the housing.No kink was observed on the representative samples.A review of the internal manufacturing device records and raw material history files for the reported lot number was performed and no recorded quality problems or rejections to this incident were found.The arterial cannula tube draw machine was reviewed, the machine parts that contact the catheter tubing are the machine grippers.However, the machine grippers have a round flat surface with no sharp edges that could cause a kink in the catheter tubing.The arterial cannula assembly machine was reviewed, there is an automated vision inspection machine at the arterial cannula assembly machine, and it will auto reject any parts not meeting the lie distance requirement.If the catheter tubing has a kink, the lie distance would most likely have failed and will automatically be rejected by the line.The returned actual sample was returned in a rubber glove without a protection tube.It is unknown if the catheter tubing of the sample could have been damaged by the packaging during delivery.Based on the investigation, the root cause for the kink / bend seen on the actual sample and returned photos could not be determined.H3 other text : see h10.
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