This report has been identified as b.Braun melsungen ag internal report # (b)(4).We received one used perifix cath.Con.2.0 g20-g24 yellow and one used perifix filter 0.2 m bulk out of an espocan w.Ds + pencan 27gx5 3/8" (0,42x without packaging.Furthermore we received one used perfusor line without packaging.The defect is due to a development error and already known.Therefore this complaint is consider as confirmed.In addition, the connection between the received catheter connector and an original packed catheter (a reference sample) was taken to a tensile strength test according to the test plan.Nominal: min.11.0 n actual: 8.52 n the tensile strength of the sample is not within our specification.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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