(b)(4).This report is being filed for an item number that is not sold in the united states, however this item or similar items are used in products that are sold in the united states by b.Braun medical, inc.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.Additional attempts to receive the sample are being made.If the sample and/or additional pertinent information becomes available, a follow up report will be submitted.
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Exemption number e2016018.B.Braun medical, inc.(importer) is submitting this report on behalf of b.Braun (b)(4) (manufacturer).This report has been identified as b.Braun (b)(4) internal report # (b)(4).The received: one picture, no samples for investigation.The picture shows a used (contaminated with blood) intrafix safeset spinlock,180cm, pierced into a 1000 ml ecoflac nacl 0.9%.The intrafix is connected with a discofix-3-way stopcock red ll, different infusion lines and an infusion bag with blood.Based on the provided picture, it is not possible to determine a leakage or damage on the discofix-3.A review of the batch and manufacturing documentation could not be performed, as no batch number has been provided.We can only take note of the complaint and file it for statistical purpose.
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