MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW AGB MAC KIT: 2L 9 FR DISTAL; INTRODUCER, CATHETER

Catalog Number	ASK-21242-BSWH2
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/30/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported, "leaking at the insertion site only when flushing or infusing the proximal lumen (white lumen).Flushes free and clear, no resistance and aspiration.No similarities with staff or inserters.No increase in volume while leaking at the insertion site.".Additional information received on 02apr2026: "the catheter was indwelling for approximately 3-4 days.There was weeping from the leaking insertion site.The multi access catheter (mac) was removed and not replaced due to therapy has been completed.".There was no report of any patient injury or consequence.The patient's current condition was reported as "fine".

• Brand Name: ARROW AGB MAC KIT: 2L 9 FR DISTAL
• Common Device Name: INTRODUCER, CATHETER
• 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: 24945982
• Report Number: 9680794-2026-00308
• Device Sequence Number: 13283002
• Product Code: OFC
• UDI-Device Identifier: 10801902220339
• UDI-Public: (01)10801902220339(11)250822(17)270331(10)33F25G0206(21)
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K011761
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/31/2026

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
• Operator of Device: Health Professional
• Device Catalogue Number: ASK-21242-BSWH2
• Device Lot Number: 33F25G0206
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/31/2026
• Supplement Date Received by Manufacturer: 05/19/2026
• Initial Report FDA Received Date: 04/21/2026
• Supplement Report FDA Received Date: 05/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/22/2025
• 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: NOT REPORTED
• Patient Sex: Unknown