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, before insertion, the tip of swg was found kinked prior to the patient.There was no reported patient harm or consequence.".
Additional Manufacturer Narrative
(b)(4).The report of a damaged guidewire was confirmed through complaint investigation of the returned sample.Visual inspection identified three kinks in the guidewire, including two towards the distal end and one in the j-bend region.The guidewire protective cap and wire snubber were not returned with the guidewire assembly.Microscopic examination confirmed the observed kinks and identified a misaligned coil along the j-bend curve at the same location.Both the distal and proximal welds were present and appeared full and spherical.The guidewire passed all relevant dimensional and functional requirements.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.During normal assembly, the kinked portion of the guidewire would be protected within the guidewire tubing.According to customer feedback, the defect was observed prior to use; however, the guidewire was manually straightened and insertion was subsequently attempted.Based on the customer report and sample received, the potential root cannot be determined as it is unknown if the damage occurred before or after the customer handled the device.Teleflex will continue to monitor and trend for complaints 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: 24869403
• Report Number: 3006425876-2026-00390
• Device Sequence Number: 9331688
• 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): 03/17/2026

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: 03/17/2026
• Initial Report FDA Received Date: 04/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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