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

Catalog Number H787108007025

Device Problem Crack (1135)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/03/2019

Event Type  malfunction  

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 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.

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
• Type of Device: SCHON¿ HEMODIALYSIS DIALYSIS CATHETER SETS,
• Manufacturer (Section D): ANGIODYNAMICS, INC; 603 queensbury avenue; queensbury NY 12804
• MDR Report Key: 9124786
• MDR Text Key: 160360357
• Report Number: 1319211-2019-00089
• Device Sequence Number: 1
• Product Code: MSD
• UDI-Device Identifier: H787108007025
• UDI-Public: H787108007025
• Combination Product (y/n): N
• PMA/PMN Number: K971925
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: 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
• Initial Date Manufacturer Received: 09/03/2019
• Initial Date FDA Received: 09/26/2019
• Supplement Dates Manufacturer Received: 09/03/2019
• Supplement Dates FDA Received: 11/27/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention