(b)(4).A device history record review was performed with a potentially relevant finding.Nonconformance 40010488 was initiated to address broken ampule issues for lot# 23f18k0787.Complaint verification testing could not be performed as no sample was returned for analysis.A device history record review was performed with a potentially relevant finding.Based on the information provided, the potential root cause of this issue is design related.A nonconformance, 40010488, was initiated to further investigate this complaint issue.
|