MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW HEMODIALYSIS KIT: 2L 14 FR X 20 CM AGB; CATHETER, HEMODIALYSIS, NON-I

Catalog Number	CDC-25142-X1A
Medical Device Problem Code	Component Missing (2306)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/03/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that "no tip on dilator.Tip of the dilator was missing.Patient was not harmed and in stable condition.".
Additional Manufacturer Narrative
(b)(4).The report of a blunt dilator tip was confirmed through complaint investigation of the returned sample.The customer returned one dilator and lidstock for analysis.Visual analysis revealed that the dilator tip was blunt and not tapered.Further dimensional analysis confirmed that the dilator length measured below specification.The outer and inner diameters measured within specification.A device history record review was performed, and no relevant findings were identified.Based on the customer report, the sample received, and the comments from manufacturing, the likely root cause is manufacturing related.Further investigation has been initiated under teleflex quality systems to evaluate this issue.
Event or Problem Description
It was reported that "no tip on dilator.Tip of the dilator was missing.Patient was not harmed and in stable condition.".

• Brand Name: ARROW HEMODIALYSIS KIT: 2L 14 FR X 20 CM AGB
• Common Device Name: CATHETER, HEMODIALYSIS, NON-I
• 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: 23670771
• Report Number: 9680794-2025-00997
• Device Sequence Number: 9808177
• Product Code: MPB
• UDI-Device Identifier: 30801902123597
• UDI-Public: (01)30801902123597(11)250424(17)260531(10)36F25B0018(21)
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• 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): 11/03/2025

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 Expiration Date: 05/31/2026
• Device Catalogue Number: CDC-25142-X1A
• Device Lot Number: 36F25B0018
• 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: 11/03/2025
• Supplement Date Received by Manufacturer: 12/05/2025
• Initial Report FDA Received Date: 11/28/2025
• Supplement Report FDA Received Date: 12/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/24/2025
• 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