Malfunction was reported.The spectra cylinders were visually inspected and functionally tested.One cylinder performed within specifications.One cylinder had a hole in the outer layer that was the result of tool damage consistent with explant damage.This cylinder was functional.Review of manufacturing documentation was performed to ensure that all required in-process and final inspections and testing were completed.Review of the manufacturing records found no evidence that the device failed to meet applicable product specifications prior to shipment from bsc.The investigation conclusion code of no problem detected was chosen as the reported device problem could not be confirmed.The event cannot be reproduced or substantiated; therefore, no escalation to ncep, capa, or scar is required.If further information is received at a later date, the product investigation will be reopened to address the additional information.
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