A review of the device history records was performed for the indicated packaging and component lots for any deviations related to the reported defect of the complaint.The review confirms that the lots met all material, assembly and performance specifications.The august 2017 angiodynamics complaint report was reviewed for the bioflo picc product family and the failure mode "catheter mis-positioned." no adverse trend was identified.As received, the used catheter was returned cut at the 20cm mark.The remainder of the catheter tubing from the 21cm mark to the 47cm mark was also returned.No compressions/kinks were noted to the returned catheter tubing.A guidewire of the same style as packaged with the catheter was obtained from inventory and inserted through each lumen.The guidewire was getting "hung up" at the 21cm mark due to bio material.After the cleaning process, the guidewire was fed through each valve until it exited the distal end of the catheter.The guidewire was easily inserted.The guidewire was then removed by pulling it back through the valve and again no difficulties were noted.Dimensions were taken of the following: tubing od, lumen height and width, wall thickness, and septum thickness.All measurements were found to be within specification.The reported complaint of malposition of the catheter tubing tip cannot be confirmed given the nature of this failure mode.The returned used sample met visual and functional specifications.Review of the returned device did not show any compressions/kinks in the catheter tubing, nor were any manufacturing non-conformance observed.A potential root cause for catheter tip malposition is tip placement too high in the svc.In addition, sources indicate that hand injections are more likely to induce tip flip and potential catheter malposition rather than power injection.The root cause cannot be definitively determined.The directions for use packaged with the bioflo pasv picc include guidance on catheter placement and maintenance.((b)(4)).
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