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

Model Number	IPN920489
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/22/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported "incident occurred on (b)(6) 2025.There was a leak issue at the juncture hub.The surgeon asked for another catheter, to change this part, the new device was not leaking.Consequence were opening another catheter to change a part and an extended time of procedure." there was no patient harm or injury.The patient's current condition is reported as "fine".
Event or Problem Description
It was reported "incident occurred on (b)(6) 2025.There was a leak issue at the juncture hub.The surgeon asked for another catheter, to change this part, the new device was not leaking.Consequence were opening another catheter to change a part and an extended time of procedure." there was no patient harm or injury.The patient's current condition is reported as "fine".
Additional Manufacturer Narrative
(b)(4) the customer returned one compression fitting for investigation.The connector assembly and compression sleeve were not returned.Visual analysis revealed no damage or defects to the compression fitting.Functional testing was performed by connecting the returned compression fitting to a connector assembly from lab inventory.The compression fitting securely and successfully connected to the assembly.Leak testing could not be performed because the connector assembly and compression sleeve were not returned for investigation.A device history record review was performed, and no relevant findings were identified.The instructions for use provided with this device cautions the user "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 report of the leak in the juncture hub could not be confirmed through investigation of the returned compression fitting.Visual analysis revealed no defects or abnormalities on the unit.Leak testing and functional testing could not be performed without the connector assembly.A device history record review was performed, and no relevant findings were identified.Based on the customer report and the sample received , what caused or contributed to this event cannot be determined.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: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 22203866
• Report Number: 9680794-2025-00487
• Device Sequence Number: 7714589
• Product Code: MSD
• UDI-Device Identifier: 00801902096333
• UDI-Public: (01)00801902096333(11)240530(17)270430(10)33F24D1039(21)
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K111117
• 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,Followup
• Report Date (Section B): 05/22/2025

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 Model Number: IPN920489
• Device Catalogue Number: CS-15242-VSP
• Device Lot Number: 33F24D1039
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/06/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/22/2025
• Supplement Date Received by Manufacturer: 06/26/2025
• Initial Report FDA Received Date: 06/13/2025
• Supplement Report FDA Received Date: 07/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/30/2024
• 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