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.As additional physical investigation was not performed on the device, a definitive root cause could not be determined for the alleged issue.A supplemental mdr will be sent if/when additional information is received.Internal complaint number: (b)(4).
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