(b)(4).No sample has been returned for investigation.Without the actual sample, a thorough investigation could not be performed and no specific conclusion can be drawn as to the cause of the reported event.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 this item or similar items are sold in the united sates by b.Braun medical, inc.
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