MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW HEMODIALYSIS KIT: 2-L 15 FR X 19 CM; CATHETER, HEMODIALYSIS, IMPLA

Catalog Number	CS-15242-SP
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/18/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported "(b)(6) 2025, in the course of dialysing a patient, the doctor found luer hub/fitting has crack." the user changed to a new set to resolve the issue.There was no patient harm or injury.No medical intervention required.The patient's current condition is reported as "fine".Associated mdr numbers include: 9680794-2025-00440, 9680794-2025-00441.
Event or Problem Description
It was reported "on (b)(6) 2025, in the course of dialysing a patient, the doctor found luer hub/fitting has crack." the user changed to a new set to resolve the issue.There was no patient harm or injury.No medical intervention required.The patient's current condition is reported as "fine".Associated mdr numbers include: 9680794-2025-00440, 9680794-2025-00441, and 9680794-2025-00442.
Additional Manufacturer Narrative
(b)(4).The customer returned one connector assembly from a hemodialysis kit for analysis.Visual analysis revealed cracks in the red arterial luer hub and in the blue venous luer hub.Minor kinks were observed on both lumens.Luer connections were functionally tested per the product instructions for use (ifu).The ifu provided with this kit instructs the user, "establish and maintain catheter patency.Solution and frequency of flushing a venous access catheter should be established in hospital/institutional policy".A lab inventory syringe filled with water was used to flush each extension line.No leaking was observed from either luer hub.A manual tug test confirmed both luer hubs were securely attached to their respective lumens.A device history record review was performed, and no relevant findings were identified.The ifu provided with this kit states, "repeated over tightening of bloodlines, syringes and caps will reduce connector life and could lead to potential connector failure." based on the investigation performed, the complaint was confirmed.The hub was observed to be cracked with stress marks around the entire circumference of both hubs.This is indicative of excess overtightening on the hub.Minor kinks were also noted.The most likely root cause of the issue is likely unintentional user error.Teleflex will continue to monitor and trend for reports of this nature.

• Brand Name: ARROW HEMODIALYSIS KIT: 2-L 15 FR X 19 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: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 21985410
• Report Number: 9680794-2025-00442
• Device Sequence Number: 4311753
• Product Code: MSD
• UDI-Device Identifier: 00801902096326
• UDI-Public: (01)00801902096326(11)231207(17)261130(10)33F23K0191(21)
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K111117
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/18/2025

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-15242-SP
• Device Lot Number: 33F23K0191
• 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: 04/18/2025
• Supplement Date Received by Manufacturer: 06/10/2025
• Initial Report FDA Received Date: 05/08/2025
• Supplement Report FDA Received Date: 06/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/07/2023
• 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.
• Patient Sex: Unknown