MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW HEMODIALYSIS SET: 2-L 15 FR X 19 CM ANTE; CATHETER, HEMODIALYSIS, IMPLA

Catalog Number	CS-15192-VFI
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that "upon checking by the renal care nurse, it was evaluated the permcath patency, it was noted to be obstructed".The user changed to a new set to complete the procedure.There was no patient complications.The patient's current condition is reproted as "critical".
Additional Manufacturer Narrative
(b)(4).The actual device was not returned; however, the customer provided five photos for analysis.The pictures showed the catheter and connector assembly removed from the patient.There were obvious signs of use in the form of blood and a suture from placement.The complaint of the catheter being blocked could not be confirmed by the photos.A complete visual inspection could not be performed as no sample was returned for analysis.A device history record review was performed, and no relevant findings were identified.The instructions for use (ifu) provided with this kit informs the user, "establish and maintain catheter patency.Solution and frequency of flushing a venous access catheter should be established in hospital/institutional policy.Volume of flush solution should be equal to the priming volume of the catheter" and "to maintain patency of catheter between treatments, a heparin-lock must be created in each lumen of catheter.Concentration of heparin used and flush frequency should be determined by hospital protocol".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 "upon checking by the renal care nurse, it was evaluated the permcath patency, it was noted to be obstructed".The user changed to a new set to complete the procedure.There was no patient complications.The patient's current condition is reproted as "critical".

• Brand Name: ARROW HEMODIALYSIS SET: 2-L 15 FR X 19 CM ANTE
• Common Device Name: CATHETER, HEMODIALYSIS, IMPLA
• Manufacturer (Section D): ARROW INTERNATIONAL LLC; morrisville NC
• Manufacturer (Section G): ARROW INTERNATIONAL DE MEXICO S.A. DE C.V.; ave. washington 3701; colonia panamericana, chihuahua; chihuahua 31200 ; MX 31200
• Manufacturer Contact: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 23391646
• Report Number: 9680794-2025-00864
• Device Sequence Number: 21345309
• Product Code: MSD
• UDI-Device Identifier: 00801902090027
• UDI-Public: (01)00801902090027(11)241209(17)271130(10)33F24L0064(21)
• Combination Product (Y/N): N
• Initial Reporter Country: RP
• PMA/510(K) Number: K141051
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/01/2025

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: CS-15192-VFI
• Device Lot Number: 33F24L0064
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/01/2025
• Supplement Date Received by Manufacturer: 11/19/2025
• Initial Report FDA Received Date: 10/27/2025
• Supplement Report FDA Received Date: 11/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/09/2024
• 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; NOT REPORTED
• Patient Sex: Unknown