(b)(4).The reported lot# for this complaint, 23f19d0265, is for kit# ak-05502 and not for the reported kit# of ask-05502-fh1.The bom for a sk-05502-fh1 indicated no ampules are packaged with this kit.Therefore, a device history record review with be performed based on the lot# reported.A device history record review was performed with a potentially relevant finding.A nonconformance was initiated only as a general nc to temporarily allow certain finished good part numbers to be packaged with additional gauze in order to better secure medication ampules in the inner tray.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 capa was initiated to further investigate this complaint issue.
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