(b)(4).We received: perifix cath.Con.2.0 g20-g24 yellow [1], filter [1], catheter [1].The following investigations were conducted: visual inspection: catheter visual inspection: no abnormalities found.There was blood found within the catheter which could not be completely removed.Connector visual inspection: no abnormalities found.Functional inspection: catheter tensile strength test.Conducted using received connector and received catheter samples.Specification: above 5.5n.Result: 8.4n (pass).Physical inspection: catheter length check.Specification: 1002.5mm ~ 1017.5mm.Result: 1015.5mm (pass).Catheter outer diameter (end of catheter).Specification: 0.80mm ~ 0.88mm.Result: 0.845mm (pass).Connection check received catheter was inserted into received connector up to the marking point without resistance.Summary and assessment: based on the conducted investigations the sample(s) are within the specification.Although the device was within specifications, 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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