A review of the device history record, which includes verification of all steps in the manufacturing of the catheter kit, verification of sterilization, and packaging for subject catheter kit was performed.The review did not identify any non-conformances, issues or capas associated with catheter kit.Device was discarded and was not returned.The agent reporting the issue stated that the cause of the migration was a loose suture on the butterfly.Per the instructions for use of the device, catheter migration is a known possible risk of use of the device.Internal complaint number: (b)(4).
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