MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW HEMODIALYSIS SET: 2-L 15 FR X 23 CM ANTE; CATHETER, HEMODIALYSIS, IMPLA

Catalog Number	CS-15232-VFIE
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 that "during initial insertion, leakage was observed from the junction hub of the chronic hemodialysis catheter while the catheter was being flushed." there was no report of any patient injury, harm or health consequences.The catheter was removed and a new catheter was inserted.The patient's current condition was reported as "good".
Additional Manufacturer Narrative
(b)(4).The actual device was not returned; however, a video was shared by the customer confirming a pin hole type leak from the distal end of the arterial extension line.A device history record review was performed, and no relevant findings were identified.Without the device to evaluate, the extent and degree of damage on the extension line could not be verified to determine the cause.Teleflex will continue to monitor and trend for reports of this nature.
Event or Problem Description
It was reported that "during initial insertion, leakage was observed from the junction hub of the chronic hemodialysis catheter while the catheter was being flushed." there was no report of any patient injury, harm or health consequences.The catheter was removed and a new catheter was inserted.The patient's current condition was reported as "good".

• Brand Name: ARROW HEMODIALYSIS SET: 2-L 15 FR X 23 CM ANTE
• Common Device Name: CATHETER, HEMODIALYSIS, IMPLA
• 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: 25029772
• Report Number: 9680794-2026-00320
• Device Sequence Number: 10126984
• Product Code: PPO
• UDI-Device Identifier: 10801902154184
• UDI-Public: (01)10801902154184(11)250618(17)280531(10)33F25F0012(21)
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K141051
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/04/2026

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: CS-15232-VFIE
• Device Lot Number: 33F25F0012
• 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: 04/04/2026
• Supplement Date Received by Manufacturer: 05/22/2026; 07/13/2026
• Initial Report FDA Received Date: 04/29/2026
• Supplement Report FDA Received Date: 06/01/2026; 07/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/18/2025
• 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