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

Model Number	IPN920517
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	Anxiety (2328)
Date of Event	02/07/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that "while preparing the connection, the nurse noticed a massive saline leak when checking the seal of the arterial branch of the catheter, along with a consequent crack.The doctor was called, and the dialysis session was performed using a single puncture on the venous branch.The catheter was replaced at another site".Additional information indicated that there was a temporary reduction of dialysis quality, the patient was reported to be 'fine'.
Event or Problem Description
It was reported that "while preparing the connection, the nurse noticed a massive saline leak when checking the seal of the arterial branch of the catheter, along with a consequent crack.The doctor was called, and the dialysis session was performed using a single puncture on the venous branch.The catheter was replaced at another site".Additional information indicated that there was a temporary reduction of dialysis quality, the patient was reported to be 'fine'.
Additional Manufacturer Narrative
Qn#(b)(4).The customer submitted 4 photos for analysis.The photos show the luer hubs of a connector assembly from a hemodialysis kit.The report of a cracked luer hub was able to be confirmed in the photos.The customer also returned one hemodialysis catheter with the connector assembly attached.Signs of user were observed.Visual analysis revealed stress marks, minor scratches, and cracking on the red arterial luer hub.No damage was observed on the blue venous luer hub.No other defects or anomalies were observed on the returned sample.The returned sample was tested per the instructions for use (ifu) provided with this kit.The ifu states "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.Leaking was observed from the crack in the red arterial luer hub.No leaking was observed from the blue venous luer hub.A manual tug test confirmed both luer hub were securely attached to their respective lumens.A device history record review was performed, and there was one potential finding.It was determined that the finding was not relevant to this event.The ifu provided with this kit informs the user, "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 investigation of the returned sample.Visual analysis revealed that the red arterial luer hub contained a crack and damage 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.

• Brand Name: ARROW 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: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 21535539
• Report Number: 9680794-2025-00202
• Device Sequence Number: 17904111
• Product Code: MSD
• UDI-Device Identifier: 00801902096302
• UDI-Public: (01)00801902096302(11)240220(17)270131(10)33F23L0940(21)
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K111117
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/18/2025

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 Model Number: IPN920517
• Device Catalogue Number: CS-15232-X
• Device Lot Number: 33F23L0940
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/05/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/18/2025
• Supplement Date Received by Manufacturer: 03/21/2025
• Initial Report FDA Received Date: 03/06/2025
• Supplement Report FDA Received Date: 04/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/20/2024
• 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