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 Codes	Material Puncture/Hole (1504); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/07/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported "x2 arterial catheterization sets were noted to be faulty.It seems the connection point between the cannula and the needle dislodged inappropriately causing the needle to bend and put a hole through the cannula." a third cannula was inserted and used successfully.There was no medical intervention required.The patient's current condition is reported as "fine".Associated mdr numbers include:9680794-2025-01045 and 9680794-2025-01033.
Additional Manufacturer Narrative
(b)(4).The actual device was not returned; however, the customer provided two photos for analysis.The complaint of a hole in the catheter was able to be confirmed by the photos.The image shows a used catheter with evidence of the needle cannula damage the catheter body, however, a complete visual inspection to determine the cause of the damage could not be performed as no sample was returned for analysis.A device history record review was performed and no relevant findings were identified.The instructions for use (ifu) provided with this kit warns the user, "precaution: do not reinsert needle into catheter; doing so may result in patient injury or catheter damage." without the device to evaluate, the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.
Event or Problem Description
It was reported "x2 arterial catheterization sets were noted to be faulty.It seems the connection point between the cannula and the needle dislodged inappropriately causing the needle to bend and put a hole through the cannula." a third cannula was inserted and used successfully.There was no medical intervention required.The patient's current condition is reported as "fine".Associated mdr numbers include:9680794-2025-01045 and 9680794-2025-01033.

• 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: 23705601
• Report Number: 9680794-2025-01033
• Device Sequence Number: 10595445
• Product Code: DQX
• UDI-Device Identifier: 00801902002730
• UDI-Public: (01)00801902002730(11)241117(17)291031(10)14F24K0938(21)
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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): 11/11/2025

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: 14F24K0938
• 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: 11/11/2025
• Supplement Date Received by Manufacturer: 12/18/2025
• Initial Report FDA Received Date: 12/03/2025
• Supplement Report FDA Received Date: 01/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/17/2024
• 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