Returned for evaluation was 115cm schon xl dialysis catheter.The sample returned was noted to have a crack in the blue hub, when tested with waster and syringe, the water dripped out of the crack of the hub.The sample was cleaned, and was sent to angiodynamics' supplier of this product, martech, for further investigation, dhr review, root cause determination and corrective action.The customer's reported complaint of a crack in the hub was confirmed.Per the supplier's response: "conclusion summary: after concluding the research, it was found that the marks in the luer are a weak welding line, created because the injection point is located at the distal side of the part, this is a contributor to the resin does not have the proper temperature to create strong join (but can be improved with new parameters); this is a combination of the mold design and parameters".As stated by the supplier: "action plan: product part number 8257 (ppm3811b) blue pvc barbed female luer and 5516 (ppm3811r) red pvc barbed female luer will be re-validated in order to find the optimal parameters to eliminate or reduce as possible the welding line.Qap264 will be updated to include a visual inspection with magnification in order to be able to detect this kind of marks.A review of the angiodynamics' device history records was performed for the reported 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.Labeling review: the instructions for use, which is supplied to the end user with states; "it is recommended that only luer lock (threaded) connections be used with this catheter (including syringes, bloodlines, iv tubing and injection caps).Repeated over tightening of bloodlines, syringes and caps will reduce connector life and could lead to potential connector failure.Inspect the catheter frequently for nicks, scrapes, cuts, etc.Which could impair it performance".A review of the angiodynamics complaint system noted no trends for this complaint type and product family.This type of complaint will continue to be monitored for trends.Complaint # (b)(4).
|