MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC HEMODIALYSIS SET: 2-LUMEN 12 FR X 16 CM; CATHETER HEMODIALYSIS NON IMPL

Catalog Number	CU-22122-F
Medical Device Problem Codes	Difficult to Advance (2920); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/10/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The customer returned one guidewire assembly and arrow raulerson syringe (ars) for analysis.The guidewire was returned within the advancer and signs of use were observed.Functional inspection of the guidewire was performed per the product instructions-for-use (ifu), which states, "advance guidewire into arrow raulerson syringe approximately 10 cm until it passes through syringe valves or into introducer needle" the guidewire was inserted through the returned ars and lab inventory 18-ga introducer needle and advanced.Resistance was encountered at the location of the kink.The undamaged portion passed with little to no resistance.A manual tug test confirmed the distal and proximal welds were intact.The report of a kinked guidewire was confirmed through complaint investigation of the returned sample.Visual inspection revealed one kink towards the center of the guidewire.Despite this, the guidewire and ars met all relevant dimensional and functional requirements.A device history record review was performed with no relevant findings.Based on these circumstances, unintentional use error likely caused or contributed to this event.Teleflex will continue to monitor and trend for complaints of this nature.
Event or Problem Description
It was reported that: "(b)(6) 2025, the occlusion of the central lumen of ars prevented the guidewire from passing through smoothly, resulting in guidewire deflection and kinking.The same issue persisted even after the catheter was replaced.The second swg and ars were used on the patient.Although there is resistance, the doctor adjusted the puncture angle and the procedure was ultimately completed successfully.No third swg and ars were used.There was no reported patient harm or consequence.".

• Brand Name: HEMODIALYSIS SET: 2-LUMEN 12 FR X 16 CM
• Common Device Name: CATHETER HEMODIALYSIS NON IMPL
• Manufacturer (Section D): ARROW INTERNATIONAL LLC; morrisville NC
• Manufacturer (Section G): ARROW INTERNATIONAL CR, A.S.; jamska 2359/47; zdar nad sazavou 591 0 1; EZ 591 01
• Manufacturer Contact: elaine cully ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 24093362
• Report Number: 3006425876-2026-00050
• Device Sequence Number: 10214677
• Product Code: MPB
• UDI-Device Identifier: 00801902100252
• UDI-Public: (01)00801902100252(11)230206(17)250112(10)71F23A2932(21)
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K993933
• 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
• Report Date (Section B): 01/06/2026

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: 01/12/2025
• Device Catalogue Number: CU-22122-F
• Device Lot Number: 71F23A2932
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/13/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/06/2026
• Initial Report FDA Received Date: 01/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/06/2023
• 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
• Patient Sex: Unknown