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

Catalog Number	CS-15242-VSP
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/28/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported "28 mar 2025, the luer hub/fitting has a crack during use on the patient." 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".
Additional Manufacturer Narrative
Qn#(b)(4).The customer returned one connector assembly and molded compression fitting for analysis.Signs of use were observed.Visual analysis revealed cracks on the red arterial luer hub and stress marks on both the red arterial and blue venous luer hub.The appearance of this damage is consistent with overtightening or repeated tightening of the hubs.Kinks were also observed on both venous and arterial extension lines.Additionally, an aneurysm on the venous extension line was observed.A small hole was observed on this aneurysm.No defects or anomalies were observed on any other portion of the returned device.Both 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 the either luer hub.Leaking was observed from the aneurysm on the venous extension line.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.".The report of a cracked luer hub was confirmed through complaint investigation of the returned sample.Visual analysis revealed cracks on the red arterial luer hub and stress marks on both the red arterial and the blue venous luer hub.This damage is consistent with overtightening or repeated tightening of the hubs.Based on the customer report and the sample received, unintentional use error likely caused or contributed to this event.Teleflex will continue to monitor and trend for reports of this nature.
Event or Problem Description
It was reported "on (b)(6) 2025, the luer hub/fitting has a crack during use on the patient.".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".
Additional Manufacturer Narrative
(b)(4).Section b.5.Was amended to include associated mdr numbers.
Event or Problem Description
It was reported "on (b)(6) 2025, the luer hub/fitting has a crack during use on the patient." 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: 9680794-2025-00328, 9680794-2025-00506, and 9680794-2025-00505.

• 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: 21832565
• Report Number: 9680794-2025-00328
• Device Sequence Number: 21143396
• Product Code: MSD
• UDI-Device Identifier: 00801902096333
• UDI-Public: (01)00801902096333(11)231206(17)261130(10)33F23K0182(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,Followup
• Report Date (Section B): 03/28/2025

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
• Device Catalogue Number: CS-15242-VSP
• Device Lot Number: 33F23K0182
• 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: 03/28/2025
• Supplement Date Received by Manufacturer: 06/05/2025; Not provided
• Initial Report FDA Received Date: 04/14/2025
• Supplement Report FDA Received Date: 06/12/2025; 06/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/06/2023
• 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