MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW ARTERIAL CATHETER KIT: 18 GA X 16 CM; WIRE, GUIDE, CATHETER

Catalog Number	ASK-04018-UPM
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/27/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "i wanted to inform you that we encountered a defective spring wire guide in one of your arterial catheterization kits on saturday, (b)(6) 2025, in the emergency department at (b)(6)." additional information received states "the spring wire guide was kinked, causing the wire to exit through the side when advanced." there was a delay in getting an art line.The patient was admitted to another floor.
Additional Manufacturer Narrative
(b)(4).
Additional Manufacturer Narrative
(b)(4).The customer provided one photo for analysis.The image shows a catheter located in a biohazard bag.Signs of use were observed in the form of biological material on the catheter body.The complaint of a kinked guidewire was not able to be confirmed by the photo.The customer also returned a 1-l catheter.Visual inspection revealed a large crimp in the catheter body towards the distal tip.Functional inspection was performed with a lab inventory guidewire of the same dimension (outer diameter 0.062mm) as it was introduced through the catheter.The guidewire passed through the catheter with minimal effort; however, through the crimped portion of the catheter, major resistance was encountered.A device history record review was performed, and no relevant findings were identified.The report of the guidewire kinked during use could not be confirmed through examination of the returned sample and customer supplied photo.The customer returned a catheter; however, the guidewire from the reported event was not returned.A crimp was observed in the catheter body; however, the customer confirmed the report is regarding the guidewire.The guidewire was not returned and therefore dimensional inspection could not be performed.The device history record review did not identify any manufacturing related issues.Based on the customer report and without the complete device returned, the root cause cannot be determined.Teleflex will continue to monitor and trend for reports of this nature.
Event or Problem Description
It was reported that "i wanted to inform you that we encountered a defective spring wire guide in one of your arterial catheterization kits on saturday, (b)(6) 2025, in the emergency department at (b)(6) hospital." additional information received states "the spring wire guide was kinked, causing the wire to exit through the side when advanced." there was a delay in getting an art line.The patient was admitted to another floor.

• Brand Name: ARROW ARTERIAL CATHETER KIT: 18 GA X 16 CM
• 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: 24162155
• Report Number: 9680794-2026-00043
• Device Sequence Number: 9029396
• Product Code: DQX
• UDI-Device Identifier: 50801902117644
• UDI-Public: (01)50801902117644(11)250421(17)270831(10)33F25C0792(21)
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K810675
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 01/02/2026

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: ASK-04018-UPM
• Device Lot Number: 33F25C0792
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/08/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/02/2026
• Supplement Date Received by Manufacturer: 01/28/2026
• Initial Report FDA Received Date: 01/23/2026
• Supplement Report FDA Received Date: 02/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/21/2025
• 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