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	Insufficient Information (4580)
Date of Event	11/03/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that: "(b)(6) 2025, according to the customer's feedback, when the syringe was routinely used to test the tightness of the dialysis tube before the patient was put on the machine for dialysis, the leak was found.After careful inspection of the joint, it was found that the luer hub/fitting has crack.Involved 2 pc." this was used about 5.5 months.".
Event or Problem Description
It was reported that: "on (b)(6) 2025, according to the customer's feedback, when the syringe was routinely used to test the tightness of the dialysis tube before the patient was put on the machine for dialysis, the leak was found.After careful inspection of the joint, it was found that the luer hub/fitting has crack.Involved 2 pc." this was used about 5.5 months.".
Additional Manufacturer Narrative
(b)(4).The details of the complaint were reviewed.The customer returned one unit of proximal catheter for evaluation.The report of a cracked luer hub was confirmed through investigation of the returned sample.Visual analysis revealed a crack on both red and blue arterial hub.No leak observed during functional test.A device history record review was performed, and one finding was observed that is similar to the failure of the reported complaint.It was determined that the observed damage is consistent with damage due to alcohol exposure.Based on the customer report and the sample received, the probable cause is likely design related.Further investigation has been initiated under teleflex quality systems to evaluate this issue.

• 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: kevin don bosco ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 23678641
• Report Number: 9680794-2025-00986
• Device Sequence Number: 8982275
• Product Code: MSD
• UDI-Device Identifier: 00801902096326
• UDI-Public: (01)00801902096326(11)240305(17)270228(10)33F24A0271(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,Company Representative,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/04/2025

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: 33F24A0271
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/19/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/04/2025
• Supplement Date Received by Manufacturer: 12/09/2025
• Initial Report FDA Received Date: 12/01/2025
• Supplement Report FDA Received Date: 12/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/05/2024
• 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