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

Model Number	IPN920517
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/07/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn# (b)(4).The customer report of compression sleeve damage was confirmed through investigation of the returned sample and customer supplied photo.Visual analysis of the sample and photo revealed the compression sleeve was torn and damaged on the threads of the connector assembly.No other defects or anomalies were observed on any other portion of the device.The observed sleeve damage is consistent with misalignment of the compression sleeve within the compression fitting prior to twisting onto the connector assembly threads.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: incident occured on (b)(6) 2025.There was a failure of the green ring at the level of the "y".The break occurred when the device was first inserted and it was immediately replaced with a second catheter.

• Brand Name: HEMODIALYSIS KIT: 2-L 15 FR X 23 CM
• 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: 23713931
• Report Number: 9680794-2025-01015
• Device Sequence Number: 8901305
• Product Code: MSD
• UDI-Device Identifier: 00801902096302
• UDI-Public: (01)00801902096302(11)250402(17)280331(10)33F25C0644(21)
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K111117
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/13/2025

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: IPN920517
• Device Catalogue Number: CS-15232-X
• Device Lot Number: 33F25C0644
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/25/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/13/2025
• Initial Report FDA Received Date: 12/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/02/2025
• 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
• Patient Sex: Unknown