Qn#(b)(4).A device history record review was performed on the kit and ampules with a potentially relevant finding.For material # k-07800-005 (lidocaine 5 ml solution), lot # 23p19l0085, according to incoming inspection records, 4 of 315 ampules were observed broken in a batch of 33600.This is outside of the parameter for this defect.For material # k-05500-042a (saline 10 ml solution), lot # 23p19l0271, according to incoming inspection records, 3 of 500 ampules were observed broken in a batch of 43200.This is outside of the parameter for this defect.A corrective action is not required at this time as a potential root cause could not be determined based upon the information provided and without a sample.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 on the lidocaine and saline solution ampules.However, the potential cause of this complaint could not be determined based upon the information provided and without the sample.
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