This report has been identified as b.Braun medical internal report number (b)(4).Two (2) photos were provided for evaluation.Upon visual inspection, it was noted that the tubing was detached from the caresite.Incidents of this nature are attributed to operator oversight during the processing of the product.During the manual assembly of this product, a bonding agent is applied to the tubing, and the tubing is then inserted into the caresite valve.During this application, it is possible that the components were not bonded correctly by the operator.Although our training procedures ensure that all of our employees are properly trained in their areas of responsibility, an oversight on the part of the operator can attribute to an incident of this nature.We will maintain this report for further references and continue to monitor other reports for similar occurrences.If additional pertinent information becomes available, a follow-up will be submitted.
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