(b)(4).A device history record review was performed on the kit and the ampules with no relevant findings.A corrective action is not required at this time as it cannot be determined at what point the saline ampule broke.However, shipping and handling could not be eliminated as potential causes.The reported complaint of a broken ampule was confirmed based upon the sample received.The saline ampule was found to have broken at the score line.No pieces of the ampule were missing.A device history record review was performed on the kit and the ampules with no evidence to suggest a manufacturing related cause.Therefore, the potential cause of a broken ampule could not be determined.However, shipping and handling could not be eliminated as potential causes.
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