(b)(4).A device history record review was performed on the kit and the lidocaine ampules with no relevant findings.The customer reported the lidocaine ampules were broken upon opening a kit.The customer returned one opened kit which contained a lidocaine solution ampule and a lidocaine w/epinephrine ampule, broken into two pieces for investigation ((b)(4)).The ampules were visually examined with and without magnification.Visual examination of both ampules revealed the ampules are broken at the score line.No pieces of the ampules 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 ampules broke.However, shipping and handling could not be eliminated as potential causes.The reported complaint of broken ampules was confirmed based upon the sample received.The lidocaine ampules were found to have broken at the score line.No pieces of the ampules were missing.A other remarks: device history record review was performed on the kit and the lidocaine ampules with no evidence to suggest a manufacturing related cause.Therefore, the potential cause of a broken ampules could not be determined.However, shipping and handling could not be eliminated as potential causes.
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