MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW CVC SET: 2-LUMEN 7 FR X 20 CM; CATHETER INTRAVASCULAR THERAPE

Catalog Number	CS-27702-E
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/15/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "(b)(6) 2025, the doctor found swg kinked during insertion." the user changed to a new set to resolve the issue.There was no patient harm or injury.No medical intervention required.The patient's current condition is reported as "fine".
Additional Manufacturer Narrative
(b)(4).
Additional Manufacturer Narrative
(b)(4).The customer returned one, opened cvc kit for analysis.No obvious signs of use were observed.The guide wire was removed from the tubing, and no obvious kinks or bends were observed.Microscopic examination confirmed that the j-bend is intact, and the distal and proximal welds are full and spherical.No other defects or anomalies were observed on the guide wire nor the tubing.The guide wire length measured 602mm, which is within the specification limits of 596mm-604mm per the guide wire product drawing.The guide wire outer diameter measured 0.800mm, which is within the specification limits of 0.788mm-0.826mm per the guide wire product drawing.The guide wire was passed through the returned ars/introducer needle subassembly.No resistance was encountered as the guide wire passed completely through the subassembly.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 are secure and intact.A device history record review was performed, and no relevant findings were identified.The ifu provided with the kit informs the user, "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 guide wire could not be confirmed through analysis of the returned sample.Visual analysis did not reveal any kinks/bends on the guide wire.Likewise, the sample 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, no problem was found with the returned device.Teleflex will continue to monitor and trend for reports of this nature.
Event or Problem Description
It was reported that "(b)(6) 2025, the doctor found swg kinked during insertion." the user changed to a new set to resolve the issue.There was no patient harm or injury.No medical intervention required.The patient's current condition is reported as "fine".

• Brand Name: ARROW CVC SET: 2-LUMEN 7 FR X 20 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: 23334729
• Report Number: 3006425876-2025-00949
• Device Sequence Number: 21463654
• Product Code: FOZ
• UDI-Device Identifier: 00801902102362
• UDI-Public: (01)00801902102362(11)240826(17)260729(10)71F24H0866(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): 09/23/2025

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 Expiration Date: 07/29/2026
• Device Catalogue Number: CS-27702-E
• Device Lot Number: 71F24H0866
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/08/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/23/2025
• Supplement Date Received by Manufacturer: 10/27/2025
• Initial Report FDA Received Date: 10/20/2025
• Supplement Report FDA Received Date: 11/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/26/2024
• 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