MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW PEDIATRIC JUGULAR SET: 20 GA X 12 CM; CATHETER PERCUTANEOUS

Catalog Number	ES-04150
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/16/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that " on (b)(6) 2025, (b)(6) hospital in department of anesthesiology the doctor found the swg kinked during use on the patient." the user changed to a new set to resolve the issue.There was no patient harm or injury.No medical intervention required.The patient's current condition is reported as "fine".
Additional Manufacturer Narrative
(b)(4) the customer returned an opened es-04150 kit with a guidewire assembly, and various components for evaluation.The guidewire was returned advanced in the guidewire assembly and signs of use were observed.The guidewire was observed to have one kinks towards the distal end of the body.The distal j bend was slightly misshapen but intact.Microscopic examination confirmed the kinks in the guide wire body.Both welds were present and were observed to be full and spherical.The kinks in the guidewire were located 13mm from the distal tip.The overall length of the guidewire measured 355.0 mm which is within the specification of 350.0-355.6 mm per guide wire product drawing.The outer diameter of the guidewire measured 0.610 mm which is within the specification of 0.610-0.635 mm per guidewire product drawing.The guidewire was advanced through a lab inventory ars and a lab inventory 18ga introducer needle to functionally test the guidewire.The guidewire passed through both components with minimal resistance.Major resistance was observed at the kinking; however, the undamaged portion of the guidewire was able to pass as expected.A manual tug test confirmed that both the distal and proximal welds were intact.A device history record review was performed, and no relevant findings were identified.The instructions for use (ifu) provided with the kit describes suggested techniques to minimize the likelihood of guide wire damage during use.The instructions caution that withdrawing the guide wire against the needle bevel or use of excessive force during removal could damage or break the wire.The report that the guidewire kinked during use was confirmed through examination of the returned sample.The returned guidewire met all relevant dimensional and functional requirements, and a device history record review did not identify any manufacturing related issues.Based on the condition of the guide wire and the report that the damage was observed during use, unintentional use error caused or contributed to this event.Teleflex will continue to monitor and trend for reports of this nature.
Event or Problem Description
It was reported that "on (b)(6)2025, (b)(6) in department of anesthesiology the doctor found the swg kinked during use on the patient." the user changed to a new set to resolve the issue.There was no patient harm or injury.No medical intervention required.The patient's current condition is reported as "fine".

• Brand Name: ARROW PEDIATRIC JUGULAR SET: 20 GA X 12 CM
• Common Device Name: CATHETER PERCUTANEOUS
• 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: 24037197
• Report Number: 9680794-2026-00005
• Device Sequence Number: 18766590
• Product Code: DQY
• UDI-Device Identifier: 00801902100535
• UDI-Public: (01)00801902100535(11)240827(17)280229(10)14F24H0114(21)
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K810962
• 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): 12/15/2025

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: ES-04150
• Device Lot Number: 14F24H0114
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/30/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/15/2025
• Supplement Date Received by Manufacturer: 01/15/2026
• Initial Report FDA Received Date: 01/12/2026
• Supplement Report FDA Received Date: 01/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/27/2024
• 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