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

Catalog Number	CS-15192-VFIE
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/25/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).N/a.Other remarks: n/a.Corrected data: n/a.
Event or Problem Description
It was reported that during dialysis, the proximal extension lumen was cut by the pinch clamp and there was leakage of blood.As a result, a new catheter was inserted.No patient harm or injury.The patient status is reported as "fine".
Event or Problem Description
It was reported that during dialysis, the proximal extension lumen was cut by the pinch clamp and there was leakage of blood.As a result, a new catheter was inserted.No patient harm or injury.The patient status is reported as "fine".
Additional Manufacturer Narrative
(b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.The customer provided a photograph of the catheter assembly in which the arterial extension line is covered in possible medical tape likely to address the reported leak.A device history record review was performed, and no relevant findings were identified.Additional information was received that the patient was fine, and the leak was on the extension line by the pinch clamp.Without the device to evaluate, the complaint could not be confirmed, and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.Other remarks: n/a.Corrected data: n/a.

• Brand Name: ARROW HEMODIALYSIS SET: 2-L 15 FR X 19 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: kevin don bosco ; 3015 carrington mill blvd; morrisville 27560
• MDR Report Key: 23595747
• Report Number: 9680794-2025-00958
• Device Sequence Number: 16047359
• Product Code: MSD
• UDI-Device Identifier: 10801902127195
• UDI-Public: (01)10801902127195(11)241013(17)270930(10)33F24J0032(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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/28/2025

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: CS-15192-VFIE
• Device Lot Number: 33F24J0032
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/28/2025
• Supplement Date Received by Manufacturer: 12/16/2025
• Initial Report FDA Received Date: 11/19/2025
• Supplement Report FDA Received Date: 12/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/13/2024
• 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: N/A.; N/A.
• Patient Sex: Unknown