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 for additional evaluation and investigation.It was reported that the cause of the fracture was unknown.Per the instructions for use of the device, catheter fracture is a known possible risk of use of the device.Internal complaint number: (b)(4).
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