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 Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/28/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "we have had two incidents with the vectorflow catheter.In both cases, the peelable introducer, which comes with the catheter kit, broke.There are two units.The incident occurred during surgery.The patient was not injured or suffered any adverse consequences, nor did he require further medical intervention." the patient's current condition is reported as "fine".Associated mdr numbers include: 9680794-2025-00314, 9680794-2025-00315, 9680794-2025-00330, and 9680794-2025-00329.
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that "we have had two incidents with the vectorflow catheter.In both cases, the peelable introducer, which comes with the catheter kit, broke.There are two units.The incident occurred during surgery.The patient was not injured or suffered any adverse consequences, nor did he require further medical intervention." the patient's current condition is reported as "fine".Associated mdr numbers include: 9680794-2025-00314, 9680794-2025-00315, 9680794-2025-00330, and 9680794-2025-00329.
Additional Manufacturer Narrative
(b)(4).Upon further review, it was determined that this complaint was created in error, thus, the initial mdr submitted on 23 april 2025 should be retracted.

• 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: keona jones ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 21889319
• Report Number: 9680794-2025-00329
• Device Sequence Number: 17026803
• Product Code: MSD
• UDI-Device Identifier: 10801902127195
• UDI-Public: (01)10801902127195(11)230823(17)260731(10)33F23G0532(21)
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K141051
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/31/2025

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: 07/31/2026
• Device Catalogue Number: CS-15192-VFIE
• Device Lot Number: 33F23G0532
• 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: 03/31/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/23/2025
• Supplement Report FDA Received Date: 05/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/23/2023
• 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