MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC HEMODIALYSIS KIT: 2-L 15 FR X 23 CM; CATHETER, HEMODIALYSIS, IMPLA

Catalog Number	CS-15282-VSP
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/06/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "(b)(6) 2025, the catheter tip was found cracked.The patient was reported as fine post the procedure.Involved 1 pc.".
Additional Manufacturer Narrative
(b)(4).The reported issue "catheter tip was found crack" could not be confirmed upon investigation of the returned sample.The customer provided picture of the issue and returned one unit of the catheter for evaluation.No damages were observed on the unit.The damages could not be confirmed on the returned unit.Functional connection with an in-house tunneler unit was successful.A device history record review was performed, and no relevant findings were identified.Based on the investigation of the returned complaint device, no issues were found.
Event or Problem Description
It was reported that"on (b)(6) 2025, the catheter tip was found cracked.The patient was reported as fine post the procedure.Involved 1 pc.".
Additional Manufacturer Narrative
(b)(4).

• Brand Name: HEMODIALYSIS KIT: 2-L 15 FR X 23 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: 23942696
• Report Number: 9680794-2026-00001
• Device Sequence Number: 10750678
• Product Code: MSD
• UDI-Device Identifier: 00801902096388
• UDI-Public: (01)00801902096388(11)220930(17)250731(10)13F22J0745(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: 07/31/2025
• Device Catalogue Number: CS-15282-VSP
• Device Lot Number: 13F22J0745
• 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: 09/30/2022
• 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.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown