MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW HEMODIALYSIS SET: 2-LUMEN 12 FR X 25 CM; CATHETER PERCUTENEOUS

Catalog Number	CS-26122-F
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/15/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that: "(b)(6) 2025, when teacher from the (b)(6) was using it, the guidewire was found kinked.They changed a new one to resolve the issue.No harm for the patient.The patient condition is fine.No medical intervention was required.Involved 1 pc.".
Additional Manufacturer Narrative
(b)(4).The report that the guidewire kinked during use could not be confirmed through examination of the returned sample.The customer returned an opened hemodialysis kit with a 2-l catheter.The guidewire was not returned and therefore dimensional and functional inspection could not be performed.The device history record review did not identify any manufacturing related issues.Based on the customer report and the returned sample, the root cause cannot be determined.Teleflex will continue to monitor and trend for reports of this nature.
Event or Problem Description
It was reported that: "(b)(6) 2025, when teacher from the nephrology department of (b)(6) hospital was using it, the guidewire was found kinked.They changed a new one to resolve the issue.No harm for the patient.The patient condition is fine.No medical intervention was required.Involved 1 pc.".

• Brand Name: ARROW HEMODIALYSIS SET: 2-LUMEN 12 FR X 25 CM
• Common Device Name: CATHETER PERCUTENEOUS
• 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: kevin don bosco ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 23987852
• Report Number: 3006425876-2026-00028
• Device Sequence Number: 4630708
• Product Code: DQY
• UDI-Device Identifier: 10801902096583
• UDI-Public: (01)10801902096583(11)231012(17)250630(10)71F23K0288(21)
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K862056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/16/2025

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 Expiration Date: 06/30/2025
• Device Catalogue Number: CS-26122-F
• Device Lot Number: 71F23K0288
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/30/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/16/2025
• Supplement Date Received by Manufacturer: 01/15/2026
• Initial Report FDA Received Date: 01/07/2026
• Supplement Report FDA Received Date: 01/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/12/2023
• 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