MAUDE Adverse Event Report: ANGIODYNAMICS, INC SCHON XL DOUBLELUMEN CATHETER; SCHON¿ HEMODIALYSIS DIALYSIS CATHETER SETS,

Catalog Number	H787108007015
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/13/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that the disposable device is not available to be returned to the manufacturer for evaluation.An investigation into the root cause of this incident is currently in progress.The results of the investigation will be sent via a follow up medwatch.Complaint # (b)(4).
Event or Problem Description
As reported: 2 schon xl 15cm length dialysis catheters; blue hubs cracked and there was leaking when injecting through the hub.The two catheters were in separate patients.They were both newly placed and exchanged that day.There wasn't any cleaning agent used as they were just initially placed.One catheter was replaced with the same and the second with a 20cm.It was reported the defective disposable device is not available for return to the manufacturer.
Additional Manufacturer Narrative
Returned for evaluation were 8 unopened 15cm schon xl dialysis catheters.The reported device used during the event was not returned.1 sample was opened for observation purposes and there were no noted defects.The sample was cleaned, and all 8 samples were 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).

• Brand Name: SCHON XL DOUBLELUMEN CATHETER
• Common Device Name: SCHON¿ HEMODIALYSIS DIALYSIS CATHETER SETS,
• Manufacturer (Section D): ANGIODYNAMICS, INC; 603 queensbury avenue; queensbury, ny NY 12804
• MDR Report Key: 9415533
• Report Number: 1319211-2019-00109
• Device Sequence Number: 19250296
• Product Code: MSD
• UDI-Device Identifier: H787108007015
• UDI-Public: H787108007015
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K971925
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 03/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/28/2021
• Device Catalogue Number: H787108007015
• Device Lot Number: MNMP150
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/09/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/13/2019
• Supplement Date Received by Manufacturer: 11/13/2019
• Initial Report FDA Received Date: 12/05/2019
• Supplement Report FDA Received Date: 03/11/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1