MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARTERIAL CATH SET:18 GA CATH/20 GA NDL; WIRE GUIDE CATHETER

Catalog Number FA-04018

Device Problem Material Twisted/Bent (2981)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/08/2024

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that "swg kinking." the issue was identified prior to use on a patient during inspection/functional testing.

• Brand Name: ARTERIAL CATH SET:18 GA CATH/20 GA NDL
• Type of Device: 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: 18635022
• MDR Text Key: 335241408
• Report Number: 9680794-2024-00114
• Device Sequence Number: 1
• Product Code: DQX
• UDI-Device Identifier: 00801902100597
• UDI-Public: 00801902100597
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: K810675
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/08/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/02/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: FA-04018
• Device Lot Number: 13F23B0372
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/27/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: NOT REPORTED