MAUDE Adverse Event Report: CENTURION MEDICAL PRODUCTS CORPORATION MEDLINE INDUSTRIES, INC.; CARDIAC CATHETERIZATION KIT

Model Number	ECVC6225A
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/04/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Middle-aged female with history of diabetes, hypertension, (b)(6), esophageal varices and asystole arrest x 1.Needle used to access vessel for triple lumen insertion had a cracked head.This prevented negative pressure from being applied when attempting to access vessel.Patient stuck multiple times before the problem was identified.No known harm to patient at this time.

• Brand Name: MEDLINE INDUSTRIES, INC.
• Common Device Name: CARDIAC CATHETERIZATION KIT
• Manufacturer (Section D): CENTURION MEDICAL PRODUCTS CORPORATION; 3310 s main st; salisbury NC 28147
• MDR Report Key: 11434943
• Report Number: 11434943
• Device Sequence Number: 4710978
• Product Code: OES
• UDI-Device Identifier: 10653160333418
• UDI-Public: (01)10653160333418(10)2021011350(17)220228
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 03/04/2021
• Report Date (Section F): 03/04/2021

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 Model Number: ECVC6225A
• Device Catalogue Number: ECVC6225A
• Device Lot Number: 2021011350
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 03/08/2021
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/08/2021
• Patient Sequence Number: 1
• Date Report Sent to FDA: 03/04/2021