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

Model Number	IPN920475
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/10/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn# (b)(4).
Event or Problem Description
It was reported "during the last insertion of this device by [doctor], who was already inserting them at the hospital, the green seal on the catheter line connector broke when the lines were being attached, without any abnormal maneuvers, and without [doctor] applying any force." the emergency seal was used and the lines were flushed.Additional information received states "the patient is currently doing well, and the catheter is continuing to be used for hemodialysis after the seal has been changed.".
Additional Manufacturer Narrative
(b)(4).The customer provided four photographs for analysis.The sleeve appeared to be cut in a spiral pattern by the threads.The complaint of the green compression sleeve tearing was able to be confirmed by the photos.A complete visual inspection could not be performed as no sample was returned for analysis.A device history record review was performed, and no relevant findings were identified.The instructions for use (ifu) provided with this kit cautions the user, "slide threaded compression cap over compression sleeve towards hub connection assembly with compression sleeve seated completely inside.Thread compression cap onto hub connection assembly firmly, but do not over tighten.There should be no threads visible on hub connection assembly" and "ensure compression sleeve is securely positioned inside threaded compression cap.Avoid attempts to place compression sleeve onto hub connection assembly cannula and then apply threaded compression cap.Incomplete compression may occur causing catheter separation".The customer report of the green compression sleeve breaking was confirmed by visual inspection of the customer supplied images.The tearing of the sleeve in the provided images is consistent with misalignment of the compression sleeve within the compression fitting prior to screwing onto the connector assembly.The ifu states "ensure compression sleeve is securely positioned inside threaded compression cap.Avoid attempts to place compression sleeve onto hub connection assembly cannula and then apply threaded compression cap.Incomplete compression may occur causing catheter separation".Full complaint verification testing could not be performed as no sample was returned for analysis.A device history record review was performed, and no relevant findings were identified.Based on the customer report and provided images, unintentional use error likely caused or contributed to the reported event.Teleflex will continue to monitor and trend on complaints of this nature.
Event or Problem Description
It was reported "during the last insertion of this device by [doctor], who was already inserting them at the hospital, the green seal on the catheter line connector broke when the lines were being attached, without any abnormal maneuvers, and without [doctor] applying any force." the emergency seal was used and the lines were flushed.Additional information received states "the patient is currently doing well, and the catheter is continuing to be used for hemodialysis after the seal has been changed.".

• Brand Name: ARROW HEMODIALYSIS SET: 2-L 15 FR X 23 CM RETR
• 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: 22700757
• Report Number: 9680794-2025-00652
• Device Sequence Number: 9150348
• Product Code: MSD
• UDI-Device Identifier: 10801902127256
• UDI-Public: (01)10801902127256(11)250122(17)271231(10)33F25A0083(21)
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K141051
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/10/2025

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: IPN920475
• Device Catalogue Number: CS-15232-VFE
• Device Lot Number: 33F25A0083
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/10/2025
• Supplement Date Received by Manufacturer: 08/26/2025
• Initial Report FDA Received Date: 08/04/2025
• Supplement Report FDA Received Date: 09/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/22/2025
• 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