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.As the device wasn't returned for additional evaluation or investigation, and the clinical specialist did not have any additional information to suggest causality, no root cause was able to be determined for the damage alleged to the catheter.Internal complaint number: (b)(4).
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