The actual device was not available; however, a photograph of the sample was provided for evaluation.During visual inspection of the provided photographic samples, a crack was observed in the arterial and venous chamber of cartridge.The crack was observed inside of the chamber to the atmosphere, suggesting that the crack occurred inside to outside.The reported condition was verified.A total of 8 retention samples were visually and functionally tested but no deviations were found.The retention samples were found within the specifications.Due to the nature of the provided samples, no further testing could be performed; therefore, the cause of the condition could not be determined.A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.Should additional relevant information become available, a supplemental report will be submitted.
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