INJECTOR AND SYRINGE, ANGIOGRAPHIC

Report

• Report Number: MW5149965
• Event Type: Injury
• Date Received: January 8, 2024
• Date of Event: October 25, 2023
• Report Date: November 30, 2023
• Manufacturer: LIEBEL-FLARSHEIM COMPANY LLC
• Product Code: DXT
• Adverse Event: Yes
• Report Source: Voluntary report
• Reporter Occupation: OTHER
• Health Professional: *

Narratives

Description of Event or Problem · 0

USE PROCESS DESCRIPTION: ON (B)(6) 2023, THE PATIENT UNDERWENT SELECTIVE ARTERIOGRAPHY + HEPATIC ARTERY EMBOLIZATION. BEFORE THE SURGERY, THE HIGH-PRESSURE SYRINGE PUMP WAS CHECKED FOR GOOD PERFORMANCE AND COULD BE USED. DURING THE SURGERY, THE TOUCH SCREEN OF THE HIGH-PRESSURE SYRINGE PUMP SUDDENLY FAILED, AND THE DRUG DOSE COULD NOT BE CHANGED AND IT COULD NOT BE USED. CALMED THE PATIENT'S EMOTIONS AND CONTACTED THE DEVICE DEPARTMENT FOR REPAIR. AFTER REPAIRED, IT WAS STILL UNUSABLE AND THERE WAS NO SPARE DEVICE, SO THE SURGERY WAS TERMINATED. REPORTED TO THE DEVICE DEPARTMENT FOR REPAIR AND TERMINATED THE SURGERY. THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
954202	INJECTOR AND SYRINGE, ANGIOGRAPHIC	INJECTOR AND SYRINGE, ANGIOGRAPHIC	DXT	LIEBEL-FLARSHEIM COMPANY LLC

Patients

Seq	Age	Sex	Outcome	Treatment
1	60 YR	Male

Terms

Patient problem · 1

• Insufficient Information

Type of report · 1

• Initial submission