MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC HEMODIALYSIS KIT: 2-L 15 FR X 23 CM; CATHETER, HEMODIALYSIS, IMPLA

Catalog Number	CS-15282-VSP
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	11/03/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that " they connector was not sealing and caused a leak used 3 catheters to find one that worked.There was no visible damage.The patient experienced substantial bleeding not normally experienced in these cases.There was no other patient injury." associated complaints: 9680794-2025-01005 and 9680794-2025-01003.
Additional Manufacturer Narrative
(b)(4).
Additional Manufacturer Narrative
(b)(4).The report of leaking at the juncture hub was able to be confirmed through investigation of the returned sample.The customer returned the connector assembly, compression sleeve, compression fitting, and part of the cut catheter from the chronic hemodialysis kit for investigation.Leak testing of the connector assembly revealed leaking between the metal cannulas and the white juncture hub.Visual inspection revealed damage to the green compression sleeve due to incorrect placement.This likely accelerated the leak in use.Additionally, the instructions-for-use (ifu) provided with this kit instructs the user, "slide threaded compression cap over compression sleeve towards hub connection assembly with compression sleeve seated completely inside." additionally, it warns, "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.".A device history record review was performed, and no relevant findings were identified.Based on the customer report and the sample received, it was concluded that this issue was related to molding in manufacturing and unintentional user error.Further investigation has been initiated under teleflex quality systems to evaluate this issue.
Event or Problem Description
It was reported that " the y connector was not sealing and caused a leak used 3 catheters to find one that worked.There was no visible damage.The patient experienced substantial bleeding not normally experienced in these cases.There was no other patient injury." associated complaints: 9680794-2025-01005, 9680794-2025-01004 and 9680794-2025-01003.

• Brand Name: HEMODIALYSIS KIT: 2-L 15 FR X 23 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: kevin don bosco ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 23705272
• Report Number: 9680794-2025-01004
• Device Sequence Number: 10691168
• Product Code: MSD
• UDI-Device Identifier: 00801902096388
• UDI-Public: (01)00801902096388(11)250218(17)280131(10)33F25A0406(21)
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K111117
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/11/2025

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-15282-VSP
• Device Lot Number: 33F25A0406
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/17/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/11/2025
• Supplement Date Received by Manufacturer: 12/05/2025
• Initial Report FDA Received Date: 12/03/2025
• Supplement Report FDA Received Date: 12/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/18/2025
• 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