As reported by the user facility: event 12: "i've been having problems with the streamlines when it's time to return patients.When we connect the arterial line to the saline line, the lines sucks air.You have to either keep screwing it on and off for it not to suck or screw it on really tight.It's like a seal in the saline line that's keep the saline from moving through the lines.No patients were injured as a result, but some blood lost due to clotting from air getting in lines.".
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Event 12: this report has been identified as b.Braun medical internal report number (b)(4).Fourteen (14) unused samples in original packages were returned for evaluation.Samples were visually evaluated, and no defects were observed.All samples were occlusion and leak tested with passing results.In addition, all samples were attached to a water line, and all locksites were tested by pushing and pulling fluid through a syringe, and on all fourteen samples, the fluid freely flows through the line.Based on the evaluation results, the defect was not confirmed.The product met internal specifications.Review of the discrepancy management system (dsms) database was performed for the reported lot number and no abnormalities or non-conformances were noted during the in process or final product inspection.We will maintain this report for further references and continue to monitor other reports for similar occurrences.If any additional pertinent information becomes available, a follow up will be submitted.
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