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 Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/03/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that "the needle tip damaged." 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).The customer returned one, opened arterial catheterization kit for analysis.No obvious signs of use were observed.The catheter was still located over the needle.The guide wire handle was in the starting position.Visual and microscopic examination of the needle bevel revealed no defects or anomalies.No other defects or anomalies were observed with the other components.The needle bevel length measured 0.0791" , which is within the specification limits of 0.0670"-0.0830" per the cannula product drawing.The cannula outer diameter measured 0.0320", which is within the specification limits of 0.0320"-0.0325" per the cannula product drawing.The cannula inner diameter at the distal tip measured 0.0230", which is within the specification limits of 0.0226"-0.0240" per the cannula product drawing.The returned arterial assembly was inserted through lab inventory simulated skin.The needle inserted with no issue.The guide wire handle was advanced, and no resistance was encountered.The guide wire deployed as intended.The catheter was then deployed off the cannula and no resistance was encountered.Performed per ifu statement, "advance entire placement device a maximum of 1 to 2 mm further into vessel to insure that catheter is seated within the vessel.Firmly hold introducer needle hub in position and advance catheter forward, over guidewire into vessel.Hold catheter in place and remove guidewire assembly.Pulsatile blood flow indicates positive arterial placement".A device history record review was performed, and no relevant findings were identified.The ifu provided with the kit informs the user, "prior to insertion, ensure guidewire is returned to the original position before insertion or blood flashback may be inhibited".The ifu also states, "care should be exercised that the catheter is not inadvertently kinked at the hub area when securing catheter to the patient as this may result in catheter damage, breakage and loss of arterial monitoring capabilities".The report of a defective needle tip was not confirmed through complaint investigation of the returned sample.Visual, dimensional, and functional analysis of the needle bevel revealed no defects or anomalies , 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 "the needle tip damaged." 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 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: 23155522
• Report Number: 9680794-2025-00801
• Device Sequence Number: 15988979
• Product Code: DQX
• UDI-Device Identifier: 00801902002761
• UDI-Public: (01)00801902002761(11)240222(17)290131(10)14F24B0189(21)
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• 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): 09/03/2025

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-04220
• Device Lot Number: 14F24B0189
• 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: 09/03/2025
• Supplement Date Received by Manufacturer: 10/21/2025
• Initial Report FDA Received Date: 09/26/2025
• Supplement Report FDA Received Date: 10/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/22/2024
• 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