(b)(4).The customer returned one, two-lumen picc for analysis.Signs-of-use in the form of biological material was observed in the proximal skive hole.After failing functional and additional testing, the catheter juncture hub was cross sectioned.Microscopic examination of the cross section revealed a small hole between the proximal and distal lumens.This is the likely cause of the backflow.The distal end of the catheter body was occluded.When the proximal lumen was pressurized, backflow was observed from the distal extension line.When the distal lumen was pressurized, backflow was observed from the proximal lumen.Water was injected through both lumens without occluding the catheter body.Both lumens functioned as intended with no observed backflow.The catheter body was occluded directly below the juncture hub.Backflow was observed coming from both extension lines when pressurizing the respective lumen.This indicates that the defect lies within the juncture hub.A device history record review was performed with no relevant findings to suggest a manufacturing related issue.The report of inter-lumen cross over was confirmed through complaint investigation.Functional testing confirmed that there was backflow coming from both the proximal and distal extension lines when pressurizing the alternate lumen.Visual analysis revealed a hole between the proximal and distal lumens, which was the likely cause of the backflow.Based on the customer description and the sample received, manufacturing caused or contributed to this event.A non-conformance request to further investigate this complaint issue.Teleflex will continue to monitor and trend for reports of this nature.
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