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 Codes	Difficult to Advance (2920); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/13/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The customer returned one 2-lumen hemodialysis catheter for analysis.Signs of use in the form of biological material were observed on the catheter body.No defects or anomalies were observed on the returned catheter.The report of a kinked catheter was not confirmed through complaint investigation.No defects or anomalies were observed on the returned catheter.The catheter met all relevant dimensional and functional requirements.A device history record review did not reveal any relevant findings.Based on the evaluation of the sample received, no problem was found on the catheter.Teleflex will continue to monitor and trend for reports of this nature.
Event or Problem Description
It was reported that: "when advancing the catheter over the guidewire, the catheter could not be inserted smoothly and kinked.The catheter was unusable.After replacement, the puncture was successful.There was no reported patient harm or consequence.".

• 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: elaine cully ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 24870437
• Report Number: 3006425876-2026-00393
• Device Sequence Number: 10020066
• Product Code: DQY
• UDI-Device Identifier: 10801902190502
• UDI-Public: (01)10801902190502(11)240911(17)290831(10)71F24J0297(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,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-12122-F
• Device Lot Number: 71F24J0297
• 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: 09/11/2024
• 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
• Patient Sex: Unknown