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	No Display/Image (1183)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/03/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "during arterial pressure monitoring in the operating room using an ra catheter, the needle tip was not visible." a new kit was used.There was no patient harm or injury.There was no medical intervention required.The patient's current condition is unknown at this time.
Additional Manufacturer Narrative
(b)(4).
Additional Manufacturer Narrative
(b)(4).The sample was returned for analysis.Visual inspection confirmed the needle cannula separated from the hub.Microscopic examination revealed that there was little to no adhesive residue on the proximal end of the cannula or in the hub.The outer diameter of the needle cannula measured 0.71mm, which is within specification limits of 0.71mm-0.72mm per needle cannula product drawing.The inner diameter of the needle hub measured 0.0300", which is within the specification limits of 0.0290"-0.0310" per needle hub product drawing.A device history record review was performed, and no relevant findings were identified.The customer report of needle cannula separation from the hub was confirmed by complaint investigation of the returned sample.Visual analysis revealed that the needle cannula had separated from the needle hub.Microscopic examination revealed that there was little to no adhesive residue on the proximal end of the cannula or in the hub.Based on the sample received, it was determined that manufacturing (assembly) caused or contributed to this event.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 "during arterial pressure monitoring in the operating room using an ra catheter, the needle tip was not visible." a new kit was used.There was no patient harm or injury.There was no medical intervention required.The patient's current condition is unknown at this time.

• 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: 23347381
• Report Number: 9680794-2025-00910
• Device Sequence Number: 15405561
• Product Code: DQX
• UDI-Device Identifier: 00801902002730
• UDI-Public: (01)00801902002730(11)250111(17)291231(10)14F24L0082(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): 10/17/2025

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: 14F24L0082
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/02/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/17/2025
• Supplement Date Received by Manufacturer: 10/22/2025
• Initial Report FDA Received Date: 10/21/2025
• Supplement Report FDA Received Date: 10/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/11/2025
• 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