MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW ARTERIAL LINE KIT: 20 GA. X 5"; CATHETER, PERCUTANEOUS

Model Number	IPN920537
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Stroke/CVA (1770)
Date of Event	01/17/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Complaint verification testing could not be performed as it was reported that the sample is not available for return.Without the device to evaluate the complaint could not be confirmed and 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 "patient lost consciousness due to a clot stroke last night".No further information was available at the time of this report.

• Brand Name: ARROW ARTERIAL LINE KIT: 20 GA. X 5"
• 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: victoria sandlin ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 16382010
• Report Number: 9680794-2023-00100
• Device Sequence Number: 6081903
• Product Code: DQY
• UDI-Device Identifier: 10801902193916
• UDI-Public: 10801902193916
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K171146
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: IPN920537
• Device Catalogue Number: ASK-00820-CL
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/18/2023
• Initial Report FDA Received Date: 02/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Patient Sex: Unknown