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	12/25/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that: "on (b)(6) 2025, the swg was found kinked prior to the patient.No harm for the patient.|the patient condition is fine.No medical intervention was required.They changed a new one to resolve the issue.".
Additional Manufacturer Narrative
(b)(4).
Additional Manufacturer Narrative
Qn: (b)(4).The report of a damaged guidewire was confirmed through visual examination of the returned sample.The customer provided one photo and returned one opened hemodialysis kit for analysis including a guidewire inside the advancer, 2-lumen catheter, dilator, and arrow raulerson syringe (ars).The advancer cap was not returned.No signs of use were observed.Visual analysis revealed one bend towards the distal end of the returned guidewire.The guidewire met all relevant dimensional and functional requirements.A device history review record did not reveal any relevant findings.Because the bend was observed in an area where the product would have been protected in the packaging, it cannot be confirmed whether the guidewire was damaged before or during handling.Due to these circumstances, the root cause of this investigation cannot be determined at this time.Teleflex will continue to monitor and trend for complaints of this nature.
Event or Problem Description
It was reported that: "(b)(6) 2025, the swg was found kinked prior to the patient.No harm for the patient.|the patient condition is fine.No medical intervention was required.They changed a new one to resolve the issue.".

• 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: kevin don bosco ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 24302547
• Report Number: 3006425876-2026-00152
• Device Sequence Number: 5240316
• Product Code: MPB
• UDI-Device Identifier: 00801902100207
• UDI-Public: (01)00801902100207(11)250415(17)270207(10)71F25D0514(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,Followup
• Report Date (Section B): 01/16/2026

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: 71F25D0514
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/28/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/16/2026
• Supplement Date Received by Manufacturer: 02/17/2026
• Initial Report FDA Received Date: 02/10/2026
• Supplement Report FDA Received Date: 02/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/15/2025
• 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; NOT REPORTED
• Patient Sex: Unknown