MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW HEMODIALYSIS SET: 2-L 15 FR X 23 CM RETR; CATHETER, HEMODIALYSIS, IMPLA

Model Number	IPN920475
Medical Device Problem Codes	Fluid/Blood Leak (1250); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/11/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn# (b)(4).
Additional Manufacturer Narrative
(b)(4).The customer returned one vectorflow hemodialysis set (cs-15232-vfe) for analysis.No signs of use in the form of biological matter were noted.Visual analysis revealed that the green compression sleeve was torn and separated into two pieces on the threaded section of the hub connection assembly.No other defects or anomalies were observed on any other portion of the returned device.The returned device was functionally tested by attempting to attach the compression sleeve and cap onto the threaded hub connection assembly.After attaching and removing the cap, it was noted that the green compression sleeve tore once again.The device was then leak tested using a lab inventory syringe.No leaks were observed on any portion of the device.A device history record review was performed, and no relevant findings were identified.The instructions for use (ifu) provided with this kit precautions the user, "ensure compression sleeve is securely positioned inside threaded compression cap.Avoid attempts to place compression sleeve onto hub connection assembly cannula and then apply threaded compression cap.Incomplete compression may occur causing catheter separation." the customer report of the green compression sleeve splitting was able to be confirmed through visual analysis of the customer returned sample.Visual analysis revealed that the green compression sleeve was torn and separated into two pieces on the threaded section of the hub connection assembly.No other defects or anomalies were observed on any other portion of the returned device.The tearing of the sleeve noted is consistent with misalignment of the compression sleeve within the compression fitting prior to twisting onto the connector assembly threads.Functional leak testing passed and no leaks were observed from any portion of the device.The ifu states "ensure compression sleeve is securely positioned inside threaded compression cap.Avoid attempts to place compression sleeve onto hub connection assembly cannula and then apply threaded compression cap.Incomplete compression may occur causing catheter separation".A device history record review was performed, and no relevant findings were identified.Based on the customer report and the returned sample, unintentional use error likely caused or contributed to this event.Teleflex will continue to monitor and trend on complaints of this nature.
Event or Problem Description
It was reported that "user complains that the green sealing ring slides over the thread when screwing and the sealing ring splits.This results in a leak at this screw connection." there was no patient harm or injury.No medical intervention required.The patient's current condition is reported as "fine".Associated mdr numbers include: 9680794-2025-00822 and 9680794-2025-00837.
Event or Problem Description
It was reported that "user complains that the green sealing ring slides over the thread when screwing and the sealing ring splits.This results in a leak at this screw connection." there was no patient harm or injury.No medical intervention required.The patient's current condition is reported as "fine".Associated mdr numbers include: (b)(4).

• Brand Name: ARROW HEMODIALYSIS SET: 2-L 15 FR X 23 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: 23244721
• Report Number: 9680794-2025-00822
• Device Sequence Number: 13340424
• Product Code: MSD
• UDI-Device Identifier: 10801902127256
• UDI-Public: (01)10801902127256(11)250325(17)280229(10)33F25C0023(21)
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K141051
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Remedial Action: Inspection
• Type of Report: Initial,Followup
• Report Date (Section B): 09/11/2025

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 Model Number: IPN920475
• Device Catalogue Number: CS-15232-VFE
• Device Lot Number: 33F25C0023
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/07/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/11/2025
• Supplement Date Received by Manufacturer: 10/23/2025
• Initial Report FDA Received Date: 10/08/2025
• Supplement Report FDA Received Date: 11/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/25/2025
• 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