MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW HEMODIALYSIS SET: 2-LUMEN 12 FR X 20 CM; CATHETER HEMODIALYTSIS NON IMP

Catalog Number	CS-25122-F
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/09/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that: "(b)(6) 2026, in icu, during the insertion, the swg was found kinked while inserting into the catheter during use on the patient.There was no reported patient harm.The device was replaced to resolve the issue.".
Additional Manufacturer Narrative
(b)(4).The customer-reported kinked guidewire observed during use was confirmed through examination of the returned sample.Visual inspection identified five kinks in the guidewire body, two of which were severe.The distal j-bend was misshapen.Microscopic examination confirmed the kinks in the guidewire body, and both the distal and proximal welds were present and were observed to be full and spherical.The returned guide wire and catheter met all relevant dimensional requirements; however, resistance was encountered at one of the kinked locations, preventing further advancement of the guidewire beyond that point during functional evaluation.No manufacturing-related defects or anomalies were identified in the returned guidewire during the investigation, and a device history record review did not identify any manufacturing related issues.Based on the condition of the guide wire and the report that the damage was observed during use, unintentional use error caused or contributed to this event.Teleflex will continue to monitor and trend for reports of this nature.

• Brand Name: ARROW HEMODIALYSIS SET: 2-LUMEN 12 FR X 20 CM
• Common Device Name: CATHETER HEMODIALYTSIS NON IMP
• Manufacturer (Section D): ARROW INTERNATIONAL LLC; morrisville NC
• Manufacturer (Section G): ARROW INTERNATIONAL CR, A.S.; jamska 2359/47; zdar nad sazavou 591 0 1; EZ 591 01
• Manufacturer Contact: elaine cully ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 24843190
• Report Number: 3006425876-2026-00389
• Device Sequence Number: 21069541
• Product Code: MPB
• UDI-Device Identifier: 10801902191165
• UDI-Public: (01)10801902191165(11)250903(17)270804(10)71F25H1253(21)
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K993933
• 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
• Report Date (Section B): 03/16/2026

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 Catalogue Number: CS-25122-F
• Device Lot Number: 71F25H1253
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/01/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/16/2026
• Initial Report FDA Received Date: 04/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/03/2025
• 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