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 Codes	Needle Stick/Puncture (2462); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/22/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported "anaethetist inserting arterial catheter had 2 failed attempts with no evidence of flash back seen.On removal strong bright blood flow indicating was in the artery on both occasions".A new kit was used to resolve the issue.The patient is fine and had no harm or injury.The associated emdr report numbers are 9680794-2025-00143.
Additional Manufacturer Narrative
(b)(4) the full udi number is not available as complainant did not report a valid lot number.
Additional Manufacturer Narrative
Qn #(b)(4).The customer returned only the product lidstock for analysis.The arterial catheterization device was not returned.Visual analysis could not be performed without the device returned.A device history record review was performed, and no relevant findings were identified.Without the device to evaluate, the complaint could not be confirmed, and 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, "anaethetist inserting arterial catheter had 2 failed attempts with no evidence of flash back seen.On removal strong bright blood flow indicating was in the artery on both occasions".A new kit was used to resolve the issue.The patient is fine and had no harm or injury.The associated emdr report numbers are 9680794-2025-00143 and 9680794-2025-00142.

• 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: 21344523
• Report Number: 9680794-2025-00142
• Device Sequence Number: 15374886
• Product Code: DQX
• UDI-Device Identifier: 00801902002730
• UDI-Public: (01)00801902002730(11)240104(17)281231(10)14F23M0113(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,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/23/2025

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
• Operator of Device: Health Professional
• Device Catalogue Number: RA-04020
• Device Lot Number: 14F23M0113
• 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: 01/23/2025
• Supplement Date Received by Manufacturer: 03/24/2025
• Initial Report FDA Received Date: 02/10/2025
• Supplement Report FDA Received Date: 04/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/04/2024
• 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