This report has been identified as b.Braun medical inc.Internal report number (b)(4).Multiple sample were returned for investigation.The received samples were checked according to test method 102000 "contamination".Upon investigation of the samples-no particles could be detected according to test specification.Further analysis of the samples was performed with the help of a microscope.The very small particles were unable to be identified.Because the complained particles cannot be detected with specified test method, the received samples are within the specifications.The complaint is classified as not confirmed.The cause of the small blue particles is the assembling process.During the process, plungers are guided in the machine with the help of a blue conveyor.Because the conveyor showed abrasion, we assume that the particles are out of this abrasion and was attracted by electrostatic charge of the plungers.Due to this report and other reports of this nature, the manufacturer has initiated a corrective action and preventive action (capa 228967 in order to further address issues with particulate contamination.
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