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	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/04/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The report of leaking at the juncture hub was able to be confirmed through investigation of the returned sample.The customer returned one vectorflow retrograde kit including the assembled catheter and tunneler for analysis.Visual analysis revealed that the compression fitting was threaded all the way onto the juncture hub, with no threads visible.Dimensional inspection revealed that the length of the arterial cannula from the juncture hub to the distal tip measured and the length of the venous cannula from the juncture hub to the distal tip measured above their respective specification limits.After initial leaking testing of the catheter assembly, the compression fitting was unscrewed.The green compression sleeve was observed to be advanced onto the threads of the juncture hub.This is consistent with incorrect assembly and can lead to incomplete compression.The leak testing of the connector assembly rev ealed leaking between the metal cannulas and the white juncture hub.A device history record (dhr) review was performed, and no relevant findings were identified.Manufacturing was contacted as part of this investigation, and they confirmed that this defect is likely molding related.Further investigation has been initiated under teleflex quality systems to evaluate this issue.
Event or Problem Description
It was reported that "i found leaking between the metal cannulas and the juncture hub, the product was leaking air while they were checking for blood aspiration, they have recut the catheter and tried to fix the issue but still the air leakage is present so they remove the catheter and use new catheter for the case.".

• 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: elaine cully ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 23776314
• Report Number: 9680794-2025-01031
• Device Sequence Number: 15973428
• Product Code: MSD
• UDI-Device Identifier: 10801902127171
• UDI-Public: (01)10801902127171(11)221201(17)251130(10)13F22L0614(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,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/18/2025

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 Expiration Date: 11/30/2025
• Device Catalogue Number: CS-15192-VFE
• Device Lot Number: 13F22L0614
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/10/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/18/2025
• Initial Report FDA Received Date: 12/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/01/2022
• 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: A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: NOT REPORTED
• Patient Sex: Unknown