(b)(4) a device history record review was performed on the kit and the saline ampule with no relevant findings.The customer reported broken ampules in the kit.The customer returned one broken saline solution ampule and lidstock.The ampule was visually examined with and without magnification.Visual examination of the ampule revealed the ampule is broken at the score line.The body of the ampule was received taped to the lidstock.The cap of the ampule appears to be missing.No other defects or anomalies were observed.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.The body of the ampule was received taped to the lidstock.The cap was missing.A device history record review was performed on the kit and the saline 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 other remarks: handling could not be eliminated as potential causes.
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