MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW HEMODIALYSIS SET: 2-L 15 FR X 19 CM RETR; CATHETER, HEMODIALYSIS, IMPLA

Catalog Number	CS-15192-VFE
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/20/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that "the blue venous extension line on the hub is leaking and pushes out air.They opened a new set to remove and use hub assembly and all worked well.".
Additional Manufacturer Narrative
(b)(4).As part of the investigation, an evaluation was conducted based on the customer-provided photograph, as no sample was returned for analysis.Visual review of the image showed the connector assembly and lidstock from a vectorflow retrograde hemodialysis kit, with the compression cap threaded onto the juncture hub and a small severed portion of the catheter body visible.No visual defects were identified, and the reported issue of leakage from the venous extension line could not be confirmed from the available evidence.Dimensional and functional testing could not be performed due to the absence of a returned sample.A review of the device history record did not identify any relevant manufacturing or quality-related findings associated with the reported lot.Based on the available information, the complaint could not be confirmed, and a definitive root cause could not be determined.There is no evidence to suggest a manufacturing-related issue.Teleflex will continue to monitor and trend for reports of this nature.
Event or Problem Description
It was reported that " the blue venous extention line on the hub is leaking and pushes out air.They opened a new set to remove and use hub assembly and all worked well.".

• Brand Name: ARROW HEMODIALYSIS SET: 2-L 15 FR X 19 CM RETR
• 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: 24626464
• Report Number: 9680794-2026-00195
• Device Sequence Number: 13028651
• Product Code: PPO
• UDI-Device Identifier: 10801902195460
• UDI-Public: (01)10801902195460(11)240528(17)270430(10)33F24D1003(21)
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• PMA/510(K) Number: K141051
• 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,Followup
• Report Date (Section B): 02/24/2026

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-15192-VFE
• Device Lot Number: 33F24D1003
• 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: 02/24/2026
• Supplement Date Received by Manufacturer: 04/01/2026; 06/30/2026
• Initial Report FDA Received Date: 03/18/2026
• Supplement Report FDA Received Date: 04/09/2026; 07/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/28/2024
• 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