There are controls in the manufacturing process to ensure the product met specifications upon release.The device was returned, and the lot number was confirmed with the packaging returned with the device.During visual inspection, the catheter shaft was found to be kinked/bent at 8.5cm from the catheter hub and flat/crushed at 6.5cm from the catheter tip.When the catheter was flushed, a leak was noted 10.5cm from the catheter hub where a hole was found on the shaft.During functional inspection, the catheter was difficult to flush; a leak was noted at 10.5cm from the catheter hub.A hole in the catheter shaft was noted.The reported event is covered in the device directions for use (dfu).As well, the risk of the reported event is documented in the risk documentation and there are current controls to mitigate the risk of the as reported event.The reported complaint was confirmed based on analysis.The device failed to meet specifications when received for complaint investigation based on the analyzed anomalies noted to the device.Additional information provided by the customer indicated that no damage was noted to the packaging prior to preparation of the device, no other anomalies were noted to the device after removal from the packaging or prior to preparation, the device was prepared as per the dfu, the dispenser hoop was flushed before removing the catheter, and no resistance was encountered when removing the catheter from the dispenser hoop.The hole found on the catheter shaft would not have left the manufacturing process due to the controls in place.An assignable cause of handling damage will be assigned the analyzed events of catheter shaft kinked/bent, catheter shaft flat/crushed, catheter shaft leak during preparation and catheter shaft has hole/perforation in this complaint since this complaint appears to be associated with handling of the product or portion of the product upon removal of the product from the packaging/preparation of the product prior to use.
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