MAUDE Adverse Event Report: Arrow International LLC ARROW HEMODIALYSIS KIT: 2-L 15 FR X 23 CM; CATHETER, HEMODIALYSIS, IMPLA

Model Number	IPN920513
Medical Device Problem Codes	Increase in Pressure (1491); Material Too Rigid or Stiff (1544); Intermittent Infusion (2341); Obstruction of Flow (2423); Deformation Due to Compressive Stress (2889)
Health Effect - Clinical Code	Hyperkalemia (4824)
Date of Event	06/24/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Continuation of d11: (b)(4).

• Brand Name: ARROW HEMODIALYSIS KIT: 2-L 15 FR X 23 CM
• Common Device Name: CATHETER, HEMODIALYSIS, IMPLA
• Manufacturer (Section D): Arrow International LLC; morrisville NC
• Manufacturer (Section G): Arrow International de Mexico S.A. DE C.V.; ave. washington 3701; colonia panamericana, chihuahua; chihuahua 31200 ; MX 31200
• Manufacturer Contact: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 50475107
• Report Number: 9680794-2026-00620
• Device Sequence Number: 10234459
• Product Code: MSD
• UDI-Device Identifier: 30801902195518
• UDI-Public: (01)30801902195518(11)230503(17)260430(10)33F23D0854
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K111117
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Type of Report: Initial,Followup
• Report Date (Section B): 07/30/2026

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
• Device Expiration Date: 04/30/2026
• Device Model Number: IPN920513
• Device Catalogue Number: CS-15282-VSP
• Device Lot Number: 33F23D0854
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/30/2026
• Supplement Date Received by Manufacturer: 09/14/2026
• Initial Report FDA Received Date: 08/27/2026
• Supplement Report FDA Received Date: 09/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/03/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: Patient requires hemodialysis three times per week.
• Patient Age: 63 YR
• Patient Sex: Male