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

Catalog Number	CS-15282-VSP
Medical Device Problem Code	Incomplete or Inadequate Connection (4037)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/28/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that: "during insertion, unale to screw the compression cap under the sleeve.Another kit was used "to" complete the procedure.There was no harm or consequence for the patient.
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: "during insertion, unale to screw the compression cap under the sleeve.Another kit was used oto complete the procedure.There was no harm or consequence for the patient.
Additional Manufacturer Narrative
(b)(4).The customer report of difficulty securing the compression cap over the compression sleeve was able to be confirmed through investigation of the customer photos, videos, and returned sample.The customer submitted two photos, one video and returned one connector assembly, one compression cap, and one compression sleeve for analysis.Signs of use were observed.The customer photos show the green compression sleeve partially advanced over the juncture hub threads, preventing threading of the white compression cap.The customer video shows an operator advancing the green compression sleeve with their fingers up to the distal edge of the juncture hub.They then attempt to thread the compression cap onto the juncture hub; however, as the compression cap is advanced, the green compression sleeve is pushed onto the threads, preventing them from securing the compression cap.Visual analysis of the returned sample revealed significant deformation to one end of the compression sleeve.A device history record review was performed, and no relevant findings were identified.Additional information was requested, and a response was received.The green compression sleeve was dried prio r to advancing the compression cap.The instruction-for-use (ifu) provided with this device states "wet compression sleeve with saline to slide components freely over catheter." additionally, it states, "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 photos, video, report and the returned sample, unintentional user error likely caused or contributed to this event.
Event or Problem Description
It was reported that: "during insertion, unable to screw the compression cap under the sleeve.Another kit was used oto complete the procedure.There was no harm or consequence for the patient.

• Brand Name: ARROW 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: 23602634
• Report Number: 9680794-2025-00969
• Device Sequence Number: 9978667
• Product Code: MSD
• UDI-Device Identifier: 00801902096388
• UDI-Public: (01)00801902096388(11)230225(17)271231(10)33F24M0007(21)
• Combination Product (Y/N): N
• Initial Reporter Country: PO
• PMA/510(K) Number: K111117
• 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,Followup
• Report Date (Section B): 10/30/2025

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: 33F24M0007
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/30/2025
• Supplement Date Received by Manufacturer: 12/17/2025; 01/22/2026
• Initial Report FDA Received Date: 11/20/2025
• Supplement Report FDA Received Date: 12/18/2025; 01/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/25/2023
• 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.; NOT REPORTED.
• Patient Sex: Unknown