This report has been identified as event 4 of b.Braun melsungen ag internal report # (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.We received three used perifix catheter connector without packaging, one used perifix catheter connector in open packaging and one perifix catheter connector in original closed packaging.The following investigations were conducted: visual inspection: the received samples were taken to a visual inspection.The catheter connectors were handed over by the customer in open condition.No damages or deviations were detected at the catheter connectors.Functional inspection: the samples were taken to functional tests according to the test plan.Nominal: it must be possible to push the catheter easily into the catheter connector.Actual: it was easily possible to push the catheter into the catheter connector.Function faults were not detected.Nominal: the catheter connector must be opened and closed 5 times with inserted catheter.Actual: the catheter connectors can be opened and closed 5 times with inserted catheter without any difficulties.A self-opening of the catheter connectors, as described by the customer, or other function faults were not detected.The function test was repeated over a period of 2 hrs (catheter connector 2 hrs in closed condition).Even after a time of 2 hrs a self-opening of the catheter connectors was not detected.Nominal: closing catheter lid: closing the catheter lid which engages with a clear click.Actual: a clear click was hearable during closing the catheter lids.Physical inspection: the received catheter connectors and a perifix catheter were taken to a tensile test, according to the test plan.Nominal: min.11 n.Actual: 8,17 n - 10,05 n.The tensile strength is not within the specification.Summary and assessment: the defect is due to a development error and already known.Therefore, this complaint is considered as confirmed.The product design is being updated to increase the force required to open the catheter connector under change control: hc-chc-m-div-1306.
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