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	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/23/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that" (b)(6) 2025, the doctor found luer hub/fitting has crack 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).The actual device was not returned; however, the customer provided one photo for analysis.The photo shows the arterial luer hub with a crack attached to a syringe.A complete visual inspection could not be performed as no sample was returned for analysis.A device history record review was performed, and no relevant findings were identified.The instructions for use (ifu) provided with this kit instructs the user, "alcohol , alcohol-based solutions (e.G.Hibiclens, chloraprep) , iodine-based solutions (povidone-iodine) peg-based ointments (e.G., bactroban), hydrogen peroxide, or exsept plus are accepted for use with this catheter at the exit site (including the juncture hub and catheter body).Ensure that solution is completely dry before applying an occlusive dressing.Warning: avoid excessive or prolonged use of alcohol-based solutions and ointments to clean catheter or site care." the ifu also instructs the user, "examine catheter and extension lines before and after each treatment for any signs of damage." the customer report of a cracked luer hub was able to be confirmed by visual inspection of the customer supplied photo.Full complaint verification testing could not be performed as no sample was returned for analysis.A device history record review was performed, and no relevant findings were identified.Additional information was received.There was no air present in the catheter during, aspiration, flushing, or during dialysis treatment.The catheter was not leaking when flushed.The patient had the catheter for about two months.The operator did not overtighten the bloodlines, syringes, or caps.Sustaining engineering was contacted as part of this complaint investigation and it was determined that the observed damage is consistent with damage due to alcohol exposure.A non-conformance has been initiated to further investigate this issue.Based on the customer report and the supplied photo, the probable cause is likely design related.Teleflex will continue to monitor and trend for reports of this nature.
Event or Problem Description
It was reported that" (b)(6) 2025, the doctor found luer hub/fitting has crack 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: 23335128
• Report Number: 9680794-2025-00856
• Device Sequence Number: 9845980
• Product Code: NFK
• UDI-Device Identifier: 00801902096111
• UDI-Public: (01)00801902096111(11)250408(17)280331(10)33F25C0685(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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/27/2025

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
• Operator of Device: Health Professional
• Device Catalogue Number: CAR-02400
• Device Lot Number: 33F25C0685
• 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: 09/27/2025
• Supplement Date Received by Manufacturer: 11/12/2025
• Initial Report FDA Received Date: 10/20/2025
• Supplement Report FDA Received Date: 11/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/08/2025
• 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; NOT REPORTED
• Patient Sex: Unknown