MAUDE Adverse Event Report: CENTURION MEDICAL PRODUCTS CENTURION; CVC INSERTION KIT

Model Number	ECVC3665
Medical Device Problem Codes	Break (1069); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/23/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Filing for initial report.Investigation of the returned sample has been delayed due to covid-19.Based on the information available, no patient injury occurred.This event is being reported based on its similarity to a previous submission.
Event or Problem Description
Guidewire frayed.
Additional Manufacturer Narrative
Based on the information available, no patient injury occurred.It should also be noted that the dimensional evaluation of the sample confirmed it was within specification.The evaluation of the returned sample was delayed due to covid-19.

• Brand Name: CENTURION
• Common Device Name: CVC INSERTION KIT
• Manufacturer (Section D): CENTURION MEDICAL PRODUCTS; 100 centurion way; williamston, mi
• MDR Report Key: 9962778
• Report Number: 1038445-2020-00002
• Device Sequence Number: 14159731
• Product Code: OES
• UDI-Device Identifier: 10653160271505
• UDI-Public: (01)10653160271505(10)2019051550(17)210131
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/15/2020

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 Expiration Date: 01/31/2021
• Device Model Number: ECVC3665
• Device Lot Number: 2019051550
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/27/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/19/2020
• Supplement Date Received by Manufacturer: 03/19/2020
• Initial Report FDA Received Date: 04/15/2020
• Supplement Report FDA Received Date: 07/02/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other