MAUDE Adverse Event Report: ANGIODYNAMICS, INC SCHON XL DOUBLE LUMEN CATHETER 20CM; SCHON¿ HEMODIALYSIS DIALYSIS CATHETER SETS,

Catalog Number	H787108007025
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/03/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Angiodynamics has notified the schon dialysis catheter manufacturer of this complaint event.The reported defective device has been returned to the manufacturer and an investigation into the root cause for event is currently in progress.The results of the device evaluation will be sent via a follow up medwatch.Complaint # (b)(4).
Event or Problem Description
As reported: we placed a schon xl non-tunneled catheter today.It aspirated and flushed with no issue.Patient was sent to the main hospital to collect stem cells.While there, the hub of the catheter was bubbling; a sign of air being aspirated.A crack in the hub was suspected, and the patient was brought back for a catheter exchange.The patient suffered no harm or injury due to this event.The reported defective disposable device has been returned to the manufacturer for evaluation.
Additional Manufacturer Narrative
Returned for evaluation was a 20cm schon xl dialysisi catheter.A crack was observed when a syringe with water was attached, when flushed it was then noted water coming from the blue hub (venous luer).The customer's complaint description is confirmed.The device was forwarded to angiodynamics' supplier of this product for evaluation, root cause determination and corrective action.Supplier stated: "multiple pictures under magnification were provided by the customer for evaluation, all of them clearly shows a crack located in the venous luer.Therefore, the reported failure mode is confirmed".Although the complaint description is confirmed, we are unable to definitively determine a root cause for this incident.A review of the 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.The instructions for use, which is supplied to the end user, 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 DOUBLE LUMEN CATHETER 20CM
• Common Device Name: SCHON¿ HEMODIALYSIS DIALYSIS CATHETER SETS,
• Manufacturer (Section D): ANGIODYNAMICS, INC; 603 queensbury avenue; queensbury NY 12804
• MDR Report Key: 9124786
• Report Number: 1319211-2019-00089
• Device Sequence Number: 2614525
• Product Code: MSD
• UDI-Device Identifier: H787108007025
• UDI-Public: H787108007025
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K971925
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 11/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/28/2021
• Device Catalogue Number: H787108007025
• Device Lot Number: MNLN680
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/11/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/03/2019
• Supplement Date Received by Manufacturer: 09/03/2019
• Initial Report FDA Received Date: 09/26/2019
• Supplement Report FDA Received Date: 11/27/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention