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	05/08/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Continuation of d11: r preparation for cardiopulmonary bypass.(b)(4).
Event or Problem Description
It was reported that "during the procedure of gaining access to the patient's right internal jugular (rij) vein with the introducer needle and 5ml syringe, the anesthesiologist became aware there was a blood and air mixture in the syringe.The anesthesiologist confirmed with ultrasound that the needle tip was appropriately in the middle of the vessel and still having a blood/air mixture.Upon closer review of the needle, it was noted there was a crack in the plastic hub portion of the steel introducer needle.The anesthesia team immediately proceeded to use a new 9fr introducer sheath without any additional issue.The patient's rij had to be punctured again.There were no reports of patient injury, harm, or adverse health consequences associated with this event.The patient's condition was reported as "fine".No additional medical intervention was reported beyond removal of the affected device, and replacement with another device.

• 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: 25411608
• Report Number: 9680794-2026-00427
• Device Sequence Number: 5840328
• Product Code: OFC
• UDI-Device Identifier: 40801902001274
• UDI-Public: (01)40801902001274(11)260108(17)300731(10)33F25J0830(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): 05/11/2026

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: 33F25J0830
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/20/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/11/2026
• Supplement Date Received by Manufacturer: 06/09/2026
• Initial Report FDA Received Date: 06/05/2026
• Supplement Report FDA Received Date: 06/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/08/2026
• 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 TO RECEIVE AN UNKNOWN AMOUNT OF HEPARIN FO
• Patient Sex: Unknown