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

Catalog Number	H787108007025
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/03/2019
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.Reference (b)(4).
Event or Problem Description
Device #1.As reported: (b)(6) said the catheter was leaking under the hub.Two devices had the same issue, both had the same lot number and upn number.Both were used on the same patient.Both catheters were replaced, the second defective catheter was replaced with a 24cm rather than a 20cm.It was reported the defective disposable device is not available for return to the manufacturer as it was disposed of by the user.
Additional Manufacturer Narrative
As the reported defective device was not returned, angiodynamics is unable to perform a device evaluation.A photo of the cracked hub was provided for evaluation.The customer's reported complaint description cannot be confirmed due to the sample not being returned although a photo was provided.A definitive root cause for the hub crack cannot be determined.Angiodynamics' supplier of this device was notified of the event.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.Labeling review: the instructions for use (ic 147), 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: 9315197
• Report Number: 1319211-2019-00104
• Device Sequence Number: 16260562
• Product Code: MSD
• UDI-Device Identifier: H787108007025
• UDI-Public: H787108007025
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/24/2020

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: 10/25/2021
• Device Catalogue Number: H787108007025
• Device Lot Number: MNGT420
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/31/2019
• Supplement Date Received by Manufacturer: 10/31/2019
• Initial Report FDA Received Date: 11/13/2019
• Supplement Report FDA Received Date: 02/24/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1