MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW HEMODIALYSIS SET: 2-LUMEN 12 FR X 16 CM; CATHETER PERCUTANEOUS

Catalog Number	CS-12122-F
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/04/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that: "the guide wire bent." there was no reported patient harm or consequence.
Event or Problem Description
It was reported that: "the guide wire bent." there was no reported patient harm or consequence.
Additional Manufacturer Narrative
(b)(4).It was reported that the guidewire was kinked.An opened hemodialysis kit, including a single guidewire within its advancer, was returned for evaluation.Visual inspection identified three kinks located along the mid-portion of the guidewire.Signs of use were present.The distal j-tip was observed to be misshapen but remained intact.Microscopic examination confirmed the presence of kinking and verified that both the distal and proximal welds were intact and secure.Dimensional inspection confirmed that the guidewire length and outer diameter were within established specification limits.The locations of the kinks were measured along the guidewire body.Functional testing was performed using the undamaged portion of the guidewire, which was successfully advanced through an introducer needle assembly with little to no resistance.A manual tug test further confirmed the integrity of the distal and proximal welds.A review of the device history record (dhr) did not identify any manufacturing or quality-related issues associated with the reported condition.Review of applicable product drawings and instructions for use (ifu) identified warnings against the application of excessive force, as this may result in component damage.The reported failure was confirmed.Based on the condition of the returned sample, the absence of manufacturing-related findings, and the information provided, the most probable root cause is attributed to unintentional use error involving the application of undue force during use.No corrective or preventive actions were initiated, as the issue is not attributed to a manufacturing deficiency.Teleflex will continue to monitor and trend for reports of this nature.

• Brand Name: ARROW HEMODIALYSIS SET: 2-LUMEN 12 FR X 16 CM
• Common Device Name: CATHETER PERCUTANEOUS
• 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: marling heaton ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 24727515
• Report Number: 3006425876-2026-00350
• Device Sequence Number: 10248428
• Product Code: DQY
• UDI-Device Identifier: 00801902100108
• UDI-Public: (01)00801902100108(11)240214(17)290131(10)71F24B0233(21)
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K862056
• 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,Followup
• Report Date (Section B): 03/04/2026

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-12122-F
• Device Lot Number: 71F24B0233
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/20/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/04/2026
• Supplement Date Received by Manufacturer: 04/08/2026
• Initial Report FDA Received Date: 03/30/2026
• Supplement Report FDA Received Date: 04/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/14/2024
• 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