It was reported that "dr.Has identified quality issues with our bard powerpicc provena lines.There is no specific differentiation for what piccs we are seeing the issue with (single vs dual, 3-5fr) wire pulls out smoothly, but then noted to have be bent to the point of nearly breaking.Risk is of dislodgment in the line/vessel" it was reported this occurred with two devices.This report addresses the second device.
|
The date of event was not provided by the complainant/reporter, the date reflected in this report is the date bd became aware of the event.The following were reviewed as part of this investigation: patient severity, applicable previous investigation(s), sample analysis, and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of kinked stylets was confirmed; however, the root cause was not identified.The product returned for evaluation was one three 4fr d/l powerpicc provena catheter kits.All three kits were received in their original sealed packages.The packages were unremarkable.The kits were opened and the included guidewires, catheters and inlaid stylets were inspected.The components appeared unremarkable.The lengths of the magnet strings were measured in all three stylet and found to be within manufacturing specifications.Microscopic inspection of the returned guidewires, catheters and stylets was unremarkable.The magnets within all three stylets were counted and found to be within manufacturing specifications.Also received were two photographs which depicted 3cg tls stylets.Both photographs depicted the plastic-coated regions of the wires, including the distal tip epoxy.Usage residues were observed on the stylet wires.Kinks were observed in both stylets approximately midway along the length of the plastic-coated regions.Both stylets appeared to be intact.No deficiencies were discovered during evaluation of the returned lot samples; however, the stylets depicted in the attached photographs both exhibited kinks within the plastic-coated regions.Inspection of the photographs was insufficient to determine a cause for the observed kinking.Consequently this complaint is confirmed as ¿cause unknown¿ at this time.Potential contributing factors include complete removal and re-insertion of the stylet during catheter trimming, insertion of the stylet past the tip of the trimmed catheter, and stylet manipulation prior to or during attempted use.A batch history review (bhr) of regq1413 showed two other similar product complaint(s) from this lot number.
|