This report has been identified as b.Braun (b)(4) internal report # (b)(4).No sample has been returned for investigation.Without the actual sample (or device), a thorough investigation could not be performed.If the sample and/or additional pertinent information becomes available, a follow up report will be submitted.The product design is being updated to increase the force required to open the catheter connector under change control: (b)(4).Note: this report is being filed for an item number that is not sold in the united states, however similar items are sold in the united states by b.Braun medical, inc.
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