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

Catalog Number	10802702
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/13/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that after the 14f x 20cm schon xl double lumen catheter had been in situ for approximately 5 days when the catheter was noted to contain air bubbles.There were not any noticeable holes, perforations, or cracks in the tubing.No bubbles entered the patient as dialysis was stopped when the bubbles were seen in the catheter.The catheter was removed and replaced with a long-term catheter.The patient did not experience any adverse effects, harm, or require medical intervention because of this incident.
Additional Manufacturer Narrative
The reported device has been returned to the manufacturer and an investigation into the root cause for event is currently in progress.The results of the investigation will be sent via a follow up medwatch.Reference (b)(4).
Additional Manufacturer Narrative
Returned for evaluation was a 14f schon dialysis catheter.The customer's complaint of "the catheter was noted to contain air bubbles" cannot be confirmed as the sample was tested and found to have no observed manufacturing non-conformances.A potential root cause for the customer having found air bubbles within the catheter could have been cause by a loose connection to the dialysis catheter (dc) luers during treatment.The schon dialysis catheter is supplied to angiodynamics by the supplier martech as a purchased finished device.Angiodynamics is distribution only and does not perform any further processing once received from martech.The device manufacturer (martech) has been notified of this event via e-mail (vendor notification).A review of the device history records was performed for the indicated lots for any deviations related to the reported failure mode of the complaint.  the review confirms that the lots met all material, assembly and performance specifications; i.E.No ncr associated with reported failure mode.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 adverse trends for this complaint type and product family.This type of complaint will continue to be monitored for trends.Reference (b)(4).

• Brand Name: SCHON XL DIALYSIS CATHETER
• Common Device Name: SCHON¿ HEMODIALYSIS DIALYSIS CATHETER SETS
• Manufacturer (Section D): ANGIODYNAMICS; 603 queensbury avenue; queensbury NY 12804
• Manufacturer (Section G): ANGIODYNAMICS; 603 queensbury avenue; queensbury NY 12804
• Manufacturer Contact: alexandra invencio ; 26 forest street; marlborough, MA 01752 ; 5086587990
• MDR Report Key: 16538000
• Report Number: 1319211-2023-00010
• Device Sequence Number: 5993303
• Product Code: MSD
• UDI-Device Identifier: H787108027025
• UDI-Public: H787108027025
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K971925
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/12/2023

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 Catalogue Number: 10802702
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/27/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/14/2023
• Supplement Date Received by Manufacturer: 04/11/2023
• Initial Report FDA Received Date: 03/14/2023
• Supplement Report FDA Received Date: 04/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 42 YR
• Patient Sex: Male
• Patient Weight: 70 KG