(b)(6).Based on the available information, this event is deemed to be a reportable malfunction.A batch record review shows that there were seal issues during the manufacture of the batch and that a process technician was called to the line to fix the problem.Two (2) photographs have been received for this complaint, which were evaluated.One (1) of the photographs confirms the lot number and the other shows the open seal.This issue will be monitored through the post market product monitoring review process.To date no additional information has been received.Should additional information become available, a follow-up report will be submitted.(b)(4).
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