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	12/10/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that: "on (b)(6) 2025, guangdong provincial hospital of traditional chinese medicine, the red luer hub was found cracked during use on the patient.The patient was reported as being fine post the procedure.There was no harm or consequence, another device was used to complete the procedure.Involved 1 pc.".
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that: "(b)(6) 2025, (b)(6), the red luer hub was found cracked during use on the patient.The patient was reported as being fine post the procedure.There was no harm or consequence, another device was used to complete the procedure.Involved 1 pc.".
Additional Manufacturer Narrative
(b)(4).The report of a cracked luer hub was confirmed through complaint investigation of the returned sample and customer submitted photos.The customer provided two photos and returned one connector assembly with the compression cap for analysis.Visual analysis revealed a crack on the red arterial luer hub.Crazing was also noted.Scratches were noted on the blue venous luer hub.Discoloration was noted.Two minor kinks were noted on the venous extension line.No other defects or anomalies were observed on any other portion of the device.The returned device passed functional testing, and no leak was noted.Additional information reported that here was no harm to the patient.Patient condition is fine.No medical intervention was needed.A new device was used to resolve the issue.A device history record review was performed, and no relevant findings were identified.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 de sign 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: 23942782
• Report Number: 9680794-2026-00003
• Device Sequence Number: 7868989
• Product Code: MSD
• UDI-Device Identifier: 00801902096333
• UDI-Public: (01)00801902096333(11)230306(17)260228(10)33F23B0749(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): 12/11/2025

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: 02/28/2026
• Device Catalogue Number: CS-15242-VSP
• Device Lot Number: 33F23B0749
• 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: 12/11/2025
• Supplement Date Received by Manufacturer: 01/26/2026
• Initial Report FDA Received Date: 01/02/2026
• Supplement Report FDA Received Date: 01/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/06/2023
• 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.
• Patient Sex: Unknown