H10: the actual device was not available; however, photographs of the sample were provided for evaluation. visual inspection was performed to the photographs using the naked eye which revealed that the male luer rigid component gets stuck into female luer connector of b braun filtered extension tubing.It was also observed the inside of female luer came out of braun extension and remained on male luer.The picture indicates the male and female luer were used; therefore, the luer was not damaged at the beginning of the treatment.The reported condition was verified. due to the nature of the sample, no additional 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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