MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW CANNON II PLUS REPLACEMENT HUB SET; KIT, REPAIR, CATHETER, HEMODI

Catalog Number	CAR-02400
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/10/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported "(b)(6) 2025, the extension line was found leaking during use on the patient." the user changed to a new set to resolve the issue.There was no patient harm or injury.No medical intervention required.The patient's current condition is reported as "fine".
Additional Manufacturer Narrative
(b)(4).
Additional Manufacturer Narrative
(b)(4) the customer returned one connector assembly from a cannon ii plus replacement hub set.Signs of use in the form of biological material were observed on the unit.Visual analysis revealed a small crack along the seam of the arterial hub.No other defects were observed.Leak testing of the returned connector assembly was performed per amrq-000075 rev.17 which states "7.3.4 extension line liquid leakage: the extension lines shall not leak liquid when tested in accordance with the method given in annex c of bs en iso 10555-1." bs en iso 10555-1:2023 states "apply a minimum pressure of 300 kpa.Maintain the pressure for a minimum of 30 s while examining the hub/connection fitting assembly and any other part of the catheter for liquid leakage, i.E.The formation of one or more falling drops of water, and record whether or not leakage occurs." both luer hubs were flushed with water and individually attached to the leak tester.With the distal end of the metal cannulas occluded, the extension lines were pressurized to 315 kpa for 30 seconds.Leaking was observed at the crack on the red arterial hub and nowhere else.A manual tug test confirmed both luer hubs were securely attached to their respective lumens.A device history record review was performed, and no relevant findings were identified.The instructions for use provided with this kit cautions the user, "repeated over tightening of bloodlines, syringes and caps will reduce connector life and could lead to potential connector failure." a report of a leak in the extension line was confirmed through complaint investigation of the returned sample.A leak test performed in accordance with iso-10555-1 revealed leaking from a crack on the red arterial luer hub.Visual analysis confirmed the small crack along the seam of the arterial luer hub.This damage is consistent with overtightening or repeated tightening of the hubs.A device history record review was performed, and no relevant findings were identified.Based on the customer report and the sample received, unintentional use error likely caused or contributed to this event.Teleflex will continue to monitor and trend for reports of this nature.
Event or Problem Description
It was reported "on (b)(6) 2025, the extension line was found leaking during use on the patient." the user changed to a new set to resolve the issue.There was no patient harm or injury.No medical intervention required.The patient's current condition is reported as "fine".

• Brand Name: ARROW CANNON II PLUS REPLACEMENT HUB SET
• Common Device Name: KIT, REPAIR, CATHETER, HEMODI
• 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: 21975902
• Report Number: 9680794-2025-00383
• Device Sequence Number: 20651329
• Product Code: NFK
• UDI-Device Identifier: 00801902096111
• UDI-Public: (01)00801902096111(11)230802(17)260630(10)33F23G0557(21)
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K020430
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/15/2025

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: 06/30/2026
• Device Catalogue Number: CAR-02400
• Device Lot Number: 33F23G0557
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/15/2025
• Supplement Date Received by Manufacturer: 06/04/2025
• Initial Report FDA Received Date: 05/07/2025
• Supplement Report FDA Received Date: 06/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/02/2023
• 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: NOT REPORTED; NOT REPORTED
• Patient Sex: Unknown