MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW HEMODIALYSIS SET: 2-L 15 FR X 31 CM RETR; CATHETER, HEMODIALYSIS, IMPLA

Model Number	IPN920510
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/08/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that "after connection of the cvc for dialysis to the extracorporea circulation, abundant air entry is evidenced into the circuit due to aspiration from a point of the branches (break) not evidenceable by visual inspection." the customer used a repair kit.There was no medical intervention required.The patient's current condition is reported as "fine".
Event or Problem Description
It was reported that "after connection of the cvc for dialysis to the extracorporea circulation, abundant air entry is evidenced into the circuit due to aspiration from a point of the branches (break) not evidenceable by visual inspection." the customer used a repair kit.There was no medical intervention required.The patient's current condition is reported as "fine".
Additional Manufacturer Narrative
(b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.The customer did not provide a lot number; therefore, a device history record review was performed based upon a lot number taken from the sales history data of the customer.No relevant findings were identified.Without the device to evaluate the complaint could not be confirmed and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.If the sample becomes available at a later date a follow up report will be submitted with investigation results.
Event or Problem Description
It was reported that "after connection of the cvc for dialysis to the extracorporea circulation, abundant air entry is evidenced into the circuit due to aspiration from a point of the branches (break) not evidenceable by visual inspection." the customer used a repair kit.There was no medical intervention required.The patient's current condition is reported as "fine".
Additional Manufacturer Narrative
(b)(4).One unit of proximal piece of the catheter (connector assembly) was returned for evaluation.No damage was observed on the juncture hub.The compression sleeve was observed to be damaged.Leak testing of the returned connector assembly was performed per amrq-000075 rev.17 which states "7.3.4 extension line liquid leakage: the extension lines shall not leak liquid when tested in accordance with the method given in annex c of bs en iso 10555-1." bs en iso 10555-1:2023 states "apply a minimum pressure of 300 kpa.Maintain the pressure for a minimum of 30 s while examining the hub/connection fitting assembly and any other part of the catheter for liquid leakage, i.E.The formation of one or more falling drops of water, and record whether or not leakage occurs." both luer hubs were individually attached to the leak tester.With the distal end of the metal cannulas occluded, the extension lines were pressurized to 300 kpa for 30 seconds.Leaking was observed from the molded section between the polymer and metal cannula.A manual tug test confirmed both luer hubs were securely attached to their respective lumens.A device history record review was performed and no relevant findings were identified.Based on the investigation performed, the most likely root cause of the issue is manufacturing/process deficiency.A non-conformance was initiated for further evaluation.Teleflex will continue to monitor and trend for reports of this nature.

• Brand Name: ARROW HEMODIALYSIS SET: 2-L 15 FR X 31 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: 21975814
• Report Number: 9680794-2025-00382
• Device Sequence Number: 9253113
• Product Code: MSD
• UDI-Device Identifier: 10801902112870
• UDI-Public: (01)10801902112870(11)241126(17)271031(10)33F24J0053(21)
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/15/2025

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 Model Number: IPN920510
• Device Catalogue Number: CS-15312-VFE
• Device Lot Number: 33F24J0053
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/15/2025
• Supplement Date Received by Manufacturer: 06/03/2025; 08/19/2025
• Initial Report FDA Received Date: 05/07/2025
• Supplement Report FDA Received Date: 06/10/2025; 08/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/26/2024
• 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