Implanted date: device was not implanted.Explanted date: device was not explanted.The 510k - k130520.The actual device was returned for evaluation.Visual inspection revealed the sampling line had been flattened.Magnifying inspection revealed no anomalies which could lead to a leak in the flattened segment.An attempt was made to circulate saline solution in the actual device.The saline solution was found to be ran through the sampling line tube with no occurrence of an anomaly, such as a leak.A review of the device history record and shipping inspection record of the involved product code/lot number combination revealed there were no indication of production related anomalies.However, it was found there was a new associate packaging the device.There is no evidence that this event was related to a device defect or malfunction.However, the investigation found that the training of a new associate for the proper positioning of the sampling line tube in the package had been insufficient.Due to this, the sampling line tube of the actual device was accidentally sandwiched between the device and the cushion material during the new associates packaging work, resulting in the reported deformation of the sampling line tube.(b)(4).
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The user facility reported while unpacking the capiox device, the customer found that the sampling line tube had been flattened.The customer decided not to use the actual device and changed it out to another one.The event occurred pre-treatment, the procedure outcome and patient condition was unknown.
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