MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW RA CATH SET: 20 GA X 1-1/2 IN; WIRE GUIDE CATHETER

Catalog Number	RA-04220
Medical Device Problem Codes	Leak/Splash (1354); Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/10/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that" on (b)(6) 2025, the anesthesiologist performed radial artery puncture catheterization for a patient undergoing general anesthesia.Before the procedure, the integrity of the catheter set's outer packaging was checked.After successful puncture, when withdrawing the needle and preparing to advance the catheter according to standard operating procedures, it was discovered that the connection between the needle and the catheter had separated, with the broken end remaining inside the catheter.After removing the needle, the remaining catheter was connected to the pressure sensor, and it was immediately noticed that there was oozing at the connection, making it impossible to form a closed monitoring circuit.The faulty arterial catheter was immediately removed, and a new puncture was performed." 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).The actual device was not returned; however, the customer provided one photo for analysis.The complaint of a cannula separating from the hub was confirmed.Signs of use were also observed, which confirms the report that the defect occurred during use.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 in removing catheter.If resistance is met on removal, stop and follow institutional policies and procedures for difficult to remove catheters".The report of a cannula separating from a needle hub was confirmed through analysis of the customer supplied image.The image shows a used needle with the cannula separated from the hub.It was determined the likely root cause is manufacturing related.A non-conformance was initiated to further investigate this complaint issue.Teleflex will continue to monitor and trend for reports of this nature.
Event or Problem Description
It was reported that"(b)(6) 2025, the anesthesiologist performed radial artery puncture catheterization for a patient undergoing general anesthesia.Before the procedure, the integrity of the catheter set's outer packaging was checked.After successful puncture, when withdrawing the needle and preparing to advance the catheter according to standard operating procedures, it was discovered that the connection between the needle and the catheter had separated, with the broken end remaining inside the catheter.After removing the needle, the remaining catheter was connected to the pressure sensor, and it was immediately noticed that there was oozing at the connection, making it impossible to form a closed monitoring circuit.The faulty arterial catheter was immediately removed, and a new puncture was performed." there was no patient harm or injury.No medical intervention required.The patient's current condition is reported as "fine".

• Brand Name: ARROW RA CATH SET: 20 GA X 1-1/2 IN
• Common Device Name: WIRE GUIDE CATHETER
• 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: 24208669
• Report Number: 9680794-2026-00050
• Device Sequence Number: 5430780
• Product Code: DQX
• UDI-Device Identifier: 00801902002761
• UDI-Public: (01)00801902002761(11)240823(17)290731(10)14F24H0116(21)
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K810675
• 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): 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 Catalogue Number: RA-04220
• Device Lot Number: 14F24H0116
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/06/2026
• Supplement Date Received by Manufacturer: 02/24/2026
• Initial Report FDA Received Date: 01/29/2026
• Supplement Report FDA Received Date: 03/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/23/2024
• 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