MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW HEMODIALYSIS SET: 2-LUMEN 12 FR X 13 CM; CATEHTER HEMODIALYSIS NON IMPL

Catalog Number	CU-23122-F
Medical Device Problem Codes	Leak/Splash (1354); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/17/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that: "on (b)(6) 2026, the shape of the luer hub is incorrect.Causing a leak.The issue was identified during use.Another device was used to resolve the issue.There was no reported patient harm.".
Additional Manufacturer Narrative
(b)(4).The customer report of a damaged luer hub was confirmed by complaint investigation of the returned sample.The customer returned one hemodialysis catheter for analysis.Signs of use in the form of biological material were observed on the catheter body and inside both extension lines.Flattening was observed on the venous luer hub.Manufacturing confirmed the observed damage would have prevented the catheter from passing required 100% leak testing; therefore, the damage likely occurred post-manufacturing.A device history record review was performed, and no relevant findings were identified.Based on the returned sample and available information, the root cause cannot be determined at this time.Teleflex will continue to monitor and trend for reports of this nature.
Event or Problem Description
It was reported that: "(b)(6) 2026, the shape of the luer hub is incorrect.Cauding a leak.The issue was identified during use.Another device was used to resolve the issue.There was no reported patient harm.".

• Brand Name: ARROW HEMODIALYSIS SET: 2-LUMEN 12 FR X 13 CM
• Common Device Name: CATEHTER HEMODIALYSIS NON IMPL
• Manufacturer (Section D): ARROW INTERNATIONAL LLC; morrisville NC
• Manufacturer (Section G): ARROW INTERNATIONAL CR, A.S.; jamska 2359/47; zdar nad sazavou 591 0 1; EZ 591 01
• Manufacturer Contact: kevin don bosco ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 24873523
• Report Number: 3006425876-2026-00486
• Device Sequence Number: 21339343
• Product Code: MPB
• UDI-Device Identifier: 00801902100269
• UDI-Public: (01)00801902100269(11)251013(17)270828(10)71F25K0275(21)
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K993933
• 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): 04/13/2026

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: CU-23122-F
• Device Lot Number: 71F25K0275
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/09/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/13/2026
• Supplement Date Received by Manufacturer: 04/29/2026
• Initial Report FDA Received Date: 04/14/2026
• Supplement Report FDA Received Date: 04/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/13/2025
• 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