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 discarded and was not returned for additional evaluation and investigation.The cause for the alleged issue was reported to be unknown.As additional physical investigation was not performed on the device, a definitive root cause could not be determined.Internal complaint number: (b)(4).
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