MAUDE Adverse Event Report: CENTURION MEDICAL PRODUCTS CENTURION INTROFLEX; CARDIAC CATHETERIZATION KIT

Model Number	ECVC6215
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Underdose (2542)
Date of Event	05/08/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Filing for initial report, investigation is ongoing.
Event or Problem Description
Sideport tubing disconnected from device.

• Brand Name: CENTURION INTROFLEX
• Common Device Name: CARDIAC CATHETERIZATION KIT
• Manufacturer (Section D): CENTURION MEDICAL PRODUCTS; 100 centurion way; williamston MI 48895
• MDR Report Key: 8656028
• Report Number: 1038445-2019-00003
• Device Sequence Number: 14071764
• Product Code: OES
• UDI-Device Identifier: 10653160314110
• UDI-Public: (01)10653160314110(10)2018121850(17)200229
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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,Followup,Followup
• Report Date (Section B): 05/30/2019

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: 02/29/2020
• Device Model Number: ECVC6215
• Device Lot Number: 2018121850
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 05/09/2019
• Supplement Date Received by Manufacturer: 08/19/2019; 08/19/2019
• Initial Report FDA Received Date: 05/30/2019
• Supplement Report FDA Received Date: 09/26/2019; 12/10/2019
• 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: Required Intervention
• Patient Weight: 65