(b)(4).A device history record review was performed on the kit and the lidocaine ampule with no relevant findings.The customer returned one opened kit for investigation ((b)(4)).The contents of the kit were visually examined with and without magnification.Visual examination of the kit revealed that the lidocaine ampule is broken at the score line.The body of the ampule was received taped in its compartment and the cap was found taped in the compartment where the prep tray goes.No other contents were present in the received kit.No pieces of the ampule appear to be missing.No other defects or anomalies were observed ((b)(4)).A corrective action is not required at this time as it cannot be determined at what point the lidocaine ampule broke.However, shipping and handling could not be eliminated as potential causes.The reported complaint of a broken other remarks: lidocaine ampule was found to have broken at the score line.The body of the ampule was found taped in its compartment.No pieces of the ampule were missing.A device history record review was performed on the kit and the lidocaine ampule 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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