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	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/14/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported "in multiple patients, vectorflow hub breakdown and the time between tube placement and dropout ranged from half a month to six months." there was no medical intervention required.The patient's current condition is reported as "fine".Associated mdr numbers include: 9680794-2025-00399, 9680794-2025-00401, and 9680794-2025-00311.
Additional Manufacturer Narrative
(b)(4) further clarification was requested regarding the complaint description and it was discovered that the event is not reportable; thus the initial mdr submitted on 24-apr-2025 should be retracted.
Event or Problem Description
It was reported "in multiple patients, vectorflow hub breakdown and the time between tube placement and dropout ranged from half a month to six months." there was no medical intervention required.The patient's current condition is reported as "fine".Associated mdr numbers include: 9680794-2025-00399, 9680794-2025-00400, 9680794-2025-00401, and 9680794-2025-00311.

• 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: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 21900005
• Report Number: 9680794-2025-00400
• Device Sequence Number: 21031304
• Product Code: MSD
• UDI-Device Identifier: 10801902127195
• UDI-Public: (01)10801902127195(11)230703(17)260630(10)33F23E0773(21)
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K141051
• 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): 04/22/2025

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: CS-15192-VFIE
• Device Lot Number: 33F23E0773
• 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: 04/22/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/24/2025
• Supplement Report FDA Received Date: 04/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/03/2023
• 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