MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW RA CATH SET: 20 GA X 1-3/4IN; WIRE GUIDE CATHETER

Catalog Number	RA-04020
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/16/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn# (b)(4).
Event or Problem Description
It was reported "during a procedure using the ra-04020 catheter in the operating room, there was no blood return after puncture." a new kit was used to resolve the issue.The patient's current condition is reported as "unknown".
Additional Manufacturer Narrative
Qn#(b)(4).The customer returned one arterial catheterization device for analysis.The catheter was advanced off the needle cannula.No obvious signs of use were observed.Visual analysis did not reveal any defects or anomalies with the needle cannula or the catheterization device.The inner diameter of the needle cannula measured 0.020", which is within the specification limits of 0.0190"-0.0205" per needle cannula product drawing.Simulated use of the returned device was performed per the instructions for use (ifu) statement, "remove guard.Trial advance and retract guidewire through needle using guidewire handle to ensure proper function.Precaution: prior to insertion, ensure guidewire is returned to the original position before insertion or blood flashback may be inhibited." the black handle on the guide wire was advanced through the track of the chamber.No resistance was experienced between the guide wire and chamber.The guide wire was returned to the original position and advanced through the needle cannula with little to no resistance.No blockage to inhibit blood flashback was observed.A resealable plastic bag was filled with water and then punctured with the needle.The bag was squeezed to pressurize the water to flow through the device.Water was observed exiting the blood hole and filling the clear hub of the catheterization device, thus, confirming fluid flashback.A device history record review was performed, and no relevant findings were identified.The report of a blocked needle was not confirmed through complaint investigation of the returned sample.The cannula met all relevant dimensional and functional requirements.No blockages were observed within the needle cannula to inhibit blood flashback.A lack of flashback is typically attributed to the insertion technique of the needle including the needle missing the vein, the vein collapsing, or the needle being positioned incorrectly, etc.Other potential use or patient variables include insufficient blood volume, dehydration, or factors like the patient's veins being small or deep set.A device history record review was performed, and no relevant findings were identified.Based on these circumstances and the returned device meeting all relevant functional requirements, no problem was found.Teleflex will continue to monitor and trend for reports of this nature.
Event or Problem Description
It was reported "during a procedure using the ra-04020 catheter in the operating room, there was no blood return after puncture." a new kit was used to resolve the issue.The patient's current condition is reported as "unknown".

• Brand Name: ARROW RA CATH SET: 20 GA X 1-3/4IN
• 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: 22201884
• Report Number: 9680794-2025-00480
• Device Sequence Number: 7643983
• Product Code: DQX
• UDI-Device Identifier: 00801902002730
• UDI-Public: (01)00801902002730(11)231213(17)281130(10)14F23M0052(21)
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K810675
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/20/2025

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: RA-04020
• Device Lot Number: 14F23M0052
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/03/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/20/2025
• Supplement Date Received by Manufacturer: 06/23/2025
• Initial Report FDA Received Date: 06/13/2025
• Supplement Report FDA Received Date: 06/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/13/2023
• 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; NOT REPORTED
• Patient Sex: Unknown