The actual device and two photographs of the sample was provided for evaluation.The reported issue was easily identified by visual inspection of the photo samples; however, the reported issue was not easily identified by initial visual inspection of the actual sample.Functional testing of sample was performed, a leak was identified from the administration spike port bonding area.The reported condition was verified.The cause of the condition could not be determined; however the cause most likely due to inadequate or lack of cyclohexanone applied to the spike port cap tube when it was inserted into the spike port during the manufacturing process causing an incorrect bonding.A nonconformance has been opened to address this issue.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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