(b)(4).We received one used perifix one 400 filterset in open packaging.The received samples were taken to a visual examination.The perifix catheter is overstretched and sheared off approximately 5 cm behind the catheter tip (see picture).The shorn off part with the catheter tip was not handed over by the customer.Such damages may occur when the catheter will be withdrawn against the cannula bevel and thereby shear off.Please see instructions for use: "never withdraw the catheter through the needle as it may otherwise shear off." therefore we assume of an application error.We exclude a manufacturing fault since the catheters were taken to a 100% examination and therefore no mechanical damages or manufacturing faults are allowed.Note: this report is being filed for the 8445801c catheter component of kit 4514009c.Kit 4514009c is the item that the issue was reported against, however kit 4514009c is not sold in the united states.The catheter component, 8445801c, is used in other perifix one kits that are assembled and sold in the united states by b.Braun medical, inc.
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