MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW HEMODIALYSIS SET: 2-L 15 FR X 27 CM RETR; CATHETER, HEMODIALYSIS, IMPLA

Catalog Number	CS-15272-VFE
Medical Device Problem Codes	Fluid/Blood Leak (1250); Incomplete or Inadequate Connection (4037)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/13/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that: "blood was found leaking from the hub connection assembly after insertion of the catheter.Therefore, the catheter was removed and replaced with a new one.No injury to the patient occurred.According to the user, the compression sleeve could not be placed onto the catheter shaft firmly so he/she suspected the product shape might have been defective.
Event or Problem Description
It was reported that: "blood was found leaking from the hub connection assembly after insertion of the catheter.Therefore, the catheter was removed and replaced with a new one.No injury to the patient occurred.According to the user, the compression sleeve could not be placed onto the catheter shaft firmly so he/she suspected the product shape might have been defective.
Additional Manufacturer Narrative
Qn# (b)(4).Complaint details were reviewed.Customer stated, " blood was found leaking from the hub connection assembly after insertion of the catheter.Therefore, the catheter was removed and replaced with a new one (lot#: unknown).No injury to the patient occurred.No photo available.According to the user, the compression sleeve could not be placed onto the catheter shaft firmly so he/she suspected the product shape might have been defective." no unit was returned for evaluation.It is unknown if the sleeve was damaged or defective.No pictures were provided by the customer to confirm the issue.Additional information was requested.A response was received.Leaking could not be resolved.Blood kept leaking until the procedure was completed.Blood transfusion was not required.Per ifu states the following steps and precautions: - 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.- slide threaded compression cap over compression sleeve towards hub connection assembly with compression sleeve seated completely inside.- thread compression cap onto hub connection assembly firmly, but do not over tighten.There should be no threads visible on hub connection assembly.- 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 dhr review was completed for lot fg lot 33f25g0637.No related non-conformities were observed.Based on limited information, the most likely root cause of the issue is undeterminable.Teleflex will continue to monitor similar issues and trends.

• Brand Name: ARROW HEMODIALYSIS SET: 2-L 15 FR X 27 CM RETR
• 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: marling heaton ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 24543122
• Report Number: 9680794-2026-00179
• Device Sequence Number: 21203651
• Product Code: PPO
• UDI-Device Identifier: 10801902154207
• UDI-Public: (01)10801902154207(11)251031(17)280928(10)33F25G0637(21)
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/13/2026

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-15272-VFE
• Device Lot Number: 33F25G0637
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/13/2026
• Supplement Date Received by Manufacturer: 04/03/2026
• Initial Report FDA Received Date: 03/09/2026
• Supplement Report FDA Received Date: 04/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/31/2025
• 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