Information was received reporting a catheter replacement.Initially, a 16ml under infusion volume discrepancy was observed and the patient complained of pain.A week later, a catheter dye study was performed in which the physician was able to aspirate the catheter.It was reported that another under infusion volume discrepancy was observed, with the expected volume being 7ml and the actual aspirated volume being 17ml.During the catheter replacement surgery, it was reported that there was a catheter kink.The cause of the kink was unknown, but the physician believed it to be a positional kink.The replaced catheter was discarded.
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A review of the device history record, which includes verification of all steps in the manufacturing of the catheter kit and sub assembly, verification of all final testing performed by/on the catheter kit and sub assembly, verification of sterilization, and packaging for subject catheter kit and sub assembly was performed.The review did not identify any non-conformances, issues or capas associated with catheter kit and sub assembly function.Device was discarded and was not returned for additional evaluation and investigation.The cause of the issue was determined to be unknown, but the physician thought it might be a positional kink of the catheter.Per the instructions for use of the device, catheter kinking is a known possible risk of use of the device.Internal complaint number: (b)(4).
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