MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW PSI KIT: 9 FR; INTRODUCER CATHETER

Catalog Number	AK-09903-J
Medical Device Problem Codes	Crack (1135); Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/13/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that during initial insertion into the internal jugular vein, a crack was observed in the introducer needle hub, resulting in leakage during aspiration.There were no reports of patient injury or adverse health consequences associated with this event.The patient's condition was reported as stable ("fine").No additional medical intervention was required beyond removal of the affected device.The procedure was subsequently completed successfully using an alternative needle from the same kit.It was also reported that multiple similar incidents involving cracks in the introducer needle hub have been identified.It was confirmed that no patients were injured in these reported incidents.In most instances, physicians were able to complete the procedure using an alternative needle available within the psi kit.Associated mdrs include (specific event) and 9680794-2026-00375 (multiple events without additional details).

• Brand Name: ARROW PSI KIT: 9 FR
• 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: 25149995
• Report Number: 9680794-2026-00372
• Device Sequence Number: 10730263
• Product Code: OFC
• UDI-Device Identifier: 40801902001274
• UDI-Public: (01)40801902001274(11)251022(17)300228(10)33F25H0026(21)
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/17/2026

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: AK-09903-J
• Device Lot Number: 33F25H0026
• 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: 04/17/2026
• Supplement Date Received by Manufacturer: 06/02/2026
• Initial Report FDA Received Date: 05/12/2026
• Supplement Report FDA Received Date: 06/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/22/2025
• 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