This report has been identified as b.Braun medical, inc.Internal report (b)(4).Failure analysis and investigation results did not confirm the reported issue.Upon receipt the used sample two simulations were performed.Scenario 1 - pierce by cannula a simulation was conducted by using a good part and piercing the capillary with cannula and later tear off the capillary.This defect is similar to cannula reinsertion where the cannula would pierce the capillary and cause it to be broken apart.The simulation sample was taken for inspection and observed that defect created was not similar to complaint sample.The capillary broken area exhibits a clear "v" shape cut from the cannula bevel.Scenario 2 - cut by scissors a good sample capillary was cut by scissors and take the sample for inspection.The defect created was similar to the complaint sample.The cut area exhibits even surface similar to the complaint sample.Conclusion: tear off capillary defect most likely not appear to be attributed by manufacturing process as the defect is able to be detected during inspection process.Damages induced after assembly process is not possible since the catheter had been protected with the protective cap.The simulation by cannula reinsertion did not produce similar defect as per complaint sample.The complaint sample defect matches with the simulation sample of being cut by sharp object such as a scissors or scalpel.The defect on the complaint sample is believed to be occurred after the cannulation process due to been cut by a sharp tool.As communicated in ifu, warning section stated that: · after withdrawal, do not reintroduce the steel needle into the catheter, as the latter may be cut off, leading to catheter embolism.Cause : defect due to wrong handling (referring to application error or off-label use) based on the results of the investigation, no conclusions can be made regarding the cause of the reported event.If additional information becomes available, a follow up report will be submitted.
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