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

Model Number	ECVC3665
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/17/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Based on the information available, no patient injury occurred.Subsequent evaluation of the returned sample determined the guidewire was broken.As a result, this event is being reported based on its similarity to a previous submission.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.
Event or Problem Description
Guidewire frayed.

• Brand Name: CENTURION
• Common Device Name: CVC INSERTION KIT
• Manufacturer (Section D): CENTURION MEDICAL PRODUCTS; 100 centurion way; williamston, mi
• MDR Report Key: 10223935
• Report Number: 1038445-2020-00009
• Device Sequence Number: 14277460
• 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
• Type of Report: Initial
• Report Date (Section B): 07/02/2020

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
• Initial 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