MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW HEMODIALYSIS SET: 2-LUMEN 12 FR X 20 CM; CATHETER PERCUTANEOUS

Catalog Number	CU-25122-F
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/14/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that: "(b)(6) 2025, a femoral vein catheterization was performed on the patient using a central venous catheter kit for hemodialysis to establish a blood purification access for dfpp treatment.No abnormalities were detected during the catheter inspection prior to placement, and the catheterization procedure proceeded smoothly without incident.During the treatment period, the on-duty nurse reported a low flow rate; given that dfpp treatment does not impose high requirements on flow rate, no intervention was implemented.The catheter was removed from the patient at 19:00 on (b)(6) 2025.Post-removal inspection revealed that the central venous catheter was bent and that there was a thrombus in the side hole.The patient's condition was closely monitored.Subsequent color doppler ultrasound examination of the patient showed no abnormalities.".
Additional Manufacturer Narrative
(b)(4).
Additional Manufacturer Narrative
(b)(4).The customer report of a kinked catheter was confirmed by visual inspection of the customer supplied photos.The image shows a used catheter with evidence of a kink towards the distal tip, however, full complaint verification testing to determine the cause of the damage could not be performed as no sample was returned for analysis.A device history record review was performed, and no relevant findings were identified.Without the device to evaluate, the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.
Event or Problem Description
It was reported that: "on (b)(6) 2025, a femoral vein catheterization was performed on the patient using a central venous catheter kit for hemodialysis to establish a blood purification access for dfpp treatment.No abnormalities were detected during the catheter inspection prior to placement, and the catheterization procedure proceeded smoothly without incident.During the treatment period, the on-duty nurse reported a low flow rate; given that dfpp treatment does not impose high requirements on flow rate, no intervention was implemented.The catheter was removed from the patient at 19:00 on (b)(6) 2025.Post-removal inspection revealed that the central venous catheter was bent and that there was a thrombus in the side hole.The patient's condition was closely monitored.Subsequent color doppler ultrasound examination of the patient showed no abnormalities." the condition of the patient was reported to be fine.A new device was used to complete the procedure.

• Brand Name: ARROW HEMODIALYSIS SET: 2-LUMEN 12 FR X 20 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: kevin don bosco ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 24256312
• Report Number: 3006425876-2026-00080
• Device Sequence Number: 12850938
• Product Code: DQY
• UDI-Device Identifier: 00801902100276
• UDI-Public: (01)00801902100276(11)250102(17)261106(10)71F24M0759(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,Followup
• Report Date (Section B): 01/07/2026

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: CU-25122-F
• Device Lot Number: 71F24M0759
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/07/2026
• Supplement Date Received by Manufacturer: 02/26/2026
• Initial Report FDA Received Date: 02/04/2026
• Supplement Report FDA Received Date: 03/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/02/2025
• 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