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	11/13/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that: "at 9:30 on (b)(6) 2025, the central venous catheter kit for hemodialysis was used to catheterize the femoral vein for the patient, establish a blood purification pathway, and perform dfpp treatment.The catheter was checked to be intact before catheterization, and the catheterization process was smooth; during the period, the feedback from the nurse on duty was that the flow rate was slow, and the intervention was not carried out because the dfpp treatment required high flow rate; at 19:00 on (b)(6) 2025, the cathter was removed.It was found that the catheter was kinked and there was thrombus in the lateral hole; preliminary treatment: observe patient, and conduct ultrasound examination to observe for swelling.Currently, there is no abnormality; the patient condition is fine.No medical intervention was required.".
Additional Manufacturer Narrative
(b)(4).
Additional Manufacturer Narrative
(b)(4).Complaint verification testing 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 complaint could not be confirmed, and 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: "at 9:30 on (b)(6) 2025, the central venous catheter kit for hemodialysis was used to catheterize the femoral vein for the patient, establish a blood purification pathway, and perform dfpp treatment.The catheter was checked to be intact before catheterization, and the catheterization process was smooth; during the period, the feedback from the nurse on duty was that the flow rate was slow, and the intervention was not carried out because the dfpp treatment required high flow rate; at 19:00 on (b)(6) 2025, the cathter was removed.It was found that the catheter was kinked and there was thrombus in the lateral hole; preliminary treatment: observe patient, and conduct ultrasound examination to observe for swelling.Currently, there is no abnormality; the patient condition is fine.No medical intervention was required.".

• 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: 23767215
• Report Number: 3006425876-2025-01152
• Device Sequence Number: 10562682
• 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): 11/18/2025

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 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: 11/18/2025
• Supplement Date Received by Manufacturer: 01/07/2026
• Initial Report FDA Received Date: 12/10/2025
• Supplement Report FDA Received Date: 01/13/2026
• 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: NO REPORTED; NO REPORTED
• Patient Sex: Unknown