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 Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/08/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The customer returned multiple components within an opened arterial kit, including one catheter and needle , for analysis.No definite signs of use were observed.Visual inspection of the catheter revealed that the catheter was kinked/flattened towards the distal end.This damage is consistent with the catheter interacting with other components during storage and shipping.The overall length of the catheter measured 6" which is within the specification limits of 5 13/16" - 6 3/16" per the catheter product drawing.The outer diameter of the undamaged portion of the catheter measured 0.056" which is within the specification limits of 0.055" - 0.059" per the catheter extrusion graphic.A lab inventory guide wire was advanced through the catheter and major resistance was experienced at the location of the kink.Despite the resistance, the guide wire was able to pass through the catheter entirely.Performed per ifu statement, "thread tip of catheter over guidewire.".Both the packaging technical manager and packaging engineers were previously contacted to determine if the damage could be related to the packaging design or component placement.It was noted that there is an inherent risk that could cause the catheter to become kinked during transit and/or excessive shipping.The catheter could become kinked if the kit was upside down and the catheter came out of its intended compartment and became wedged between the small flat tray and the edge of the inner tray or got damaged by other components.A device history record review was performed, and no relevant findings were identified.The customer report of a kinked catheter was confirmed through complaint investigation of the returned sample.Visual and functional inspections revealed one kink/flattened portion towards the distal end of the catheter body.Despite this, the catheter met all relevant dimensional inspection.Based on these circumstances, and comments previously provided by packaging engineering, the probable root cause is related to storage and shipping.Teleflex will continue to monitor and trend for complaints of this nature.
Event or Problem Description
It was reported "catheter in kit was crushed flattened near the tip of the catheter." no patient harm or injury.No medical intervention required.The patient's current condition is reported as "fine".

• 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: keona jones ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 19260426
• Report Number: 9680794-2024-00387
• Device Sequence Number: 17795803
• Product Code: DQX
• UDI-Device Identifier: 50801902117644
• UDI-Public: 50801902117644
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K810675
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/09/2024

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 Expiration Date: 01/31/2026
• Device Catalogue Number: ASK-04018-UPM
• Device Lot Number: 33F24A0259
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/12/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/09/2024
• Initial Report FDA Received Date: 05/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/18/2024
• 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: NONE REPORTED.
• Patient Sex: Unknown