A review of the device history record, which includes verification of all steps in the manufacturing of the us catheter kit, verification of all final testing performed by/on the us catheter kit, and packaging for subject us catheter kit was performed.The review did not identify any non-conformances, issues or capas associated with us catheter kit function.Device was not returned.Per the instructions for use of the intrathecal catheter, catheter leak is a known possible risk of use of the device.Internal complaint number: (b)(4).
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