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.Revised segment of catheter was discarded and not returned.The cause of the damaged catheter was confirmed to be that the pump stem had punctured it.Per the instructions for use of the device, catheter tears and breaks are known possible risks of use of the device.Internal complaint number: (b)(4).
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