MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW CVC SET: 3-LUMEN 12 FR X 16 CM; CATHETER INTRAVASCULAR THERAPE

Catalog Number	CS-22123-F
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/13/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "on 13 nov 2025, in (b)(6) hospital, the doctor found the swg kinked and can't use." the user changed to a new set to resolve the issue.There was no patient harm or injury.The patient's current condition is reported as "fine".
Additional Manufacturer Narrative
(b)(4).
Additional Manufacturer Narrative
(b)(4).The customer provided two photos for analysis.The complaint of a kinked guidewire was able to be confirmed by the photos.The guidewire is within the assembly and the cap is not in place.Biological material is observed on the guidewire.The customer also returned one, opened cvc kit for analysis.The guide wire assembly will be analyzed as part of this complaint.Signs of use were observed on the guide wire surface, which contradicts the customer report that the defect was observed "prior to use".The customer was contacted, and they confirmed that the biological material was from the customer handling the sample with bloody gloves.Initial visual analysis also revealed that the guide wire was inverted within the tubing.Further analysis revealed kinking/bending across the guide wire.Microscopic examination confirmed the damage and revealed that the distal and proximal welds are full and spherical.When fully assembled inside the returned tubing, all locations of the kinking are located inside the tubing, protecting it from damage within the kit.The guide wire length measured 600mm, which is within the specification limits of 596mm-604mm per the guide wire product drawing.The guide wire outer diameter measured 0.850mm, which is within the specification limits of 0.838mm-0.877mm per the guide wire product drawing.The guide wire was advanced through a lab inventory arrow raulerson syringe (ars) and 18ga introducer needle.Resistance was encountered at the location of the kinks.All functional sections of the guide wire passed with no issue.Performed per ifu statement, "advance guidewire into arrow raulerson syringe approximately 10 cm until it passes through syringe valves or into introducer needle".A manual tug test confirmed that the distal and proximal welds were secure and intact.A device history record review was performed and no relevant findings were identified.The ifu provided with this kit warns the user, "do not use if package is damaged." and "do not use excessive force when introducing guidewire or tissue dilator as this can lead to vessel perforation, bleeding, or component damage." the report of a kinked guidewire was confirmed through complaint investigation of the returned sample.Visual analysis revealed kinking/bending across guide wire.When fully assembled inside the returned tubing , the kinking/bending is located inside the tubing, protecting it from damage.Signs of use in the form of biological material were observed, which contradicts the customer report that the defect occurred prior to use.The guide wire met all relevant dimensional and functional requirements, and a device history record review did not reveal any relevant findings.Based on the customer report and the sample received, the root cause cannot be determined at this time as it is unknown if the damage occurred before or after the customer handled.Teleflex will continue to monitor and trend for reports of this nature.
Event or Problem Description
It was reported that "(b)(6) 2025, in (b)(6) hospital, the doctor found the swg kinked and can't use." the user changed to a new set to resolve the issue.There was no patient harm or injury.The patient's current condition is reported as "fine".

• Brand Name: ARROW CVC SET: 3-LUMEN 12 FR X 16 CM
• Common Device Name: CATHETER INTRAVASCULAR THERAPE
• 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: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 23715454
• Report Number: 3006425876-2025-01132
• Device Sequence Number: 21403352
• Product Code: FOZ
• UDI-Device Identifier: 00801902102188
• UDI-Public: (01)00801902102188(11)241216(17)261021(10)71F24M0631(21)
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K900263
• 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): 11/13/2025

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-22123-F
• Device Lot Number: 71F24M0631
• 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: 11/13/2025
• Supplement Date Received by Manufacturer: 01/08/2026
• Initial Report FDA Received Date: 12/04/2025
• Supplement Report FDA Received Date: 01/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/16/2024
• 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