The actual device was not available; however, a photograph of the sample was provided for evaluation along with six retained samples.The photograph shows the set was damaged and appeared ¿squashed¿.The reported condition was verified.The cause of the damaged set was concluded to be the packaging machine.This product will be transferred to another baxter site and will no longer be produced at the malta site.Visual inspection of the retention samples did not identify any abnormalities that could have contributed to the reported condition.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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