H10: three (3) actual devices were received for evaluation.Visual inspection did not identify any abnormalities that could have contributed to the reported condition.The bags underwent functional leak testing and after several minutes the bags were filled with tap water leaks were observed originating from the spike port bonding area in all three bags.The reported condition was verified in all three bags.The cause of the condition could not be determined; however, the most probable cause was 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 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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