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

Catalog Number	CS-15242-VSP
Medical Device Problem Code	Component Incompatible (1108)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/27/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that on (b)(6) 2026, "the event involved a 72-year-old female patient who was having a tunneled catheter inserted for end-stage chronic kidney disease and gram-negative bacteremia.The catheter could not be inserted due to a defective threaded connection.As a result, the device was replaced." patient condition was reported as "fine".Good faith efforts were made to obtain additional information regarding the reported device issue and the patient's clinical outcome.However, no response or additional information was received.
Additional Manufacturer Narrative
(b)(4) the customer returned one connector assembly for analysis.No signs of use were observed.Visual inspection revealed no defects or anomalies on any portion of the device.No catheter body, compression cap, or compression sleeve were returned for investigation.A lab inventory syringe was used to test the connection to the luer hubs.The syringe connected to the threads of the luer hubs with no difficulty.A compression sleeve and compression cap from a lab inventory device was attached to test the connection of the juncture hub.The cap and sleeve connected to the threads of the juncture hub with no difficulty.A device history record review was performed, and no relevant findings were identified.The instructions for use (ifu) provided with this kit warns the user, "warning: green compression sleeve must be present when threading compression cap onto hub connection assembly.Failure to do so may result in air embolism, blood loss, or catheter separation.Precaution: ensure compression sleeve is securely positioned inside threaded compression cap.Avoid attempts to place compression sleeve onto hub connection assembly cannula and then apply threaded compression cap.Incomplete compression may occur causing catheter separation." the customer report of threaded connection failure could not be confirmed through investigation of the returned sample.Visual analysis revealed no defects or anomalies on any portion of the device.Functional testing passed when testing the threads with lab inventory components.A device history record review was performed and no relevant findings were identified.Without the catheter body, compression cap, or compression sleeve, the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.

• Brand Name: ARROW HEMODIALYSIS KIT: 2-L 15 FR X 19 CM
• 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: angela meister ; 3015 carrington mill blvd; morrisville 27560
• MDR Report Key: 25261288
• Report Number: 9680794-2026-00403
• Device Sequence Number: 10512153
• Product Code: PPO
• UDI-Device Identifier: 10801902154221
• UDI-Public: (01)10801902154221(11)250401(17)280331(10)33F25C0657(21)
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/28/2026

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-15242-VSP
• Device Lot Number: 33F25C0657
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/11/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/28/2026
• Initial Report FDA Received Date: 05/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/01/2025
• 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.
• Patient Age: 72 YR
• Patient Sex: Unknown