MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW ACCESS TRAY; CATHETER, PERCUTANEOUS

Catalog Number	UM-04018
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/15/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported "this is a direct quote from nurse manager from physician our intensivist dr (b)(6) has complaints about the kit.He says the 18g needle is too blunt and will not penetrate the artery.The catheter will not go through the artery either because it's too blunt, so he has to put more pressure than the guide wire bends." there was no patient harm or injury.No medical intervention required.The patient's current condition is reported as "fine".
Additional Manufacturer Narrative
Qn # (b)(4).
Additional Manufacturer Narrative
(b)(4) the actual device was not returned; however, the customer provided one photo for analysis.The complaint of a kinked guidewire was not able to be confirmed by the photo, which only shows the lidstock provided with this kit.A complete visual inspection could not be performed as no sample was returned for analysis.A device history record review was performed, and no relevant findings were identified.The instructions for use (ifu) provided with this kit warns the user, "remove guidewire and catheter together as a unit.Use of excessive force may damage catheter or guidewire.Warning: to reduce the risk of guidewire damage, do not retract guidewire against edge of needle while in vessel." without the device to evaluate, 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 "this is a direct quote from nurse manager from physician our intensivist dr g.Has complaints about the kit.He says the 18g needle is too blunt and will not penetrate the artery.The catheter will not go through the artery either because it's too blunt, so he has to put more pressure than the guide wire bends." there was no patient harm or injury.No medical intervention required.The patient's current condition is reported as "fine".

• Brand Name: ARROW ACCESS TRAY
• 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: 21977898
• Report Number: 9680794-2025-00405
• Device Sequence Number: 9252729
• Product Code: DQY
• UDI-Device Identifier: 10801902118889
• UDI-Public: (01)10801902118889(11)241125(17)270331(10)33F24K0306(21)
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K810962
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/18/2025

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: UM-04018
• Device Lot Number: 33F24K0306
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/18/2025
• Supplement Date Received by Manufacturer: 06/06/2025
• Initial Report FDA Received Date: 05/07/2025
• Supplement Report FDA Received Date: 06/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/25/2024
• 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