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
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".Kl 4/14/2025.
Additional Manufacturer Narrative
Qn#(b)(4).
Event or Problem Description
It was reported "(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).One unit of hemodialysis catheter was returned for evaluation.Hub was observed to be cracked on both venous and arterial ends.Stress marks were also noted that is indicative of overtightening effect.Secondary failures were observed that includes: the lumen kinked on both arterial and venous extension - compression sleeve damaged and split into two pieces - leak observed from the extension lumen of the venous side.The returned connector assembly was tested per the instructions for use (ifu) provided with this kit.The ifu states, "flush hub connection assembly with sterile normal saline for injection and clamp extension lines to contain saline within lumen(s)." a lab inventory syringe filled with water was used to flush the connector assembly.No leaks were observed from the cracks.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 most likely root cause of the issue is unintentional user error.
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: 9680794-2025-00327, 9680794-2025-00504, 9680794-2025-00503, and 9680794-2025-00502.
Additional Manufacturer Narrative
(b)(4).Section b.5.Was amended to include associated mdr numbers.

• 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: 21832509
• Report Number: 9680794-2025-00327
• Device Sequence Number: 18485264
• 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: 06/10/2025; 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