MAUDE Adverse Event Report: CONMED CORPORATION STAT 2; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	P-S2-12 N
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/23/2020
Type of Reportable Event	Malfunction
Event or Problem Description
Elderly female with history of hypertension and diabetes.While having a diagnostic heart catheterization, it was noticed that the dial a flow that was set on 20, was running wide open.Device was removed, no known harm to the patient.This same situation happened a few days prior.There are 2 lot numbers in the same-day cardiac surgical area that could have been used for both of these cases.

• Brand Name: STAT 2
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): CONMED CORPORATION; 525 french road; utica NY 13502
• MDR Report Key: 10902624
• Report Number: 10902624
• Device Sequence Number: 1282932
• Product Code: FPA
• UDI-Device Identifier: 00653405047462
• UDI-Public: (01)00653405047462(17)220504(10)202005044
• 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): 11/23/2020
• Report Date (Section F): 11/23/2020

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: P-S2-12 N
• Device Catalogue Number: P-S2-12 N
• Device Lot Number: 202005044
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 11/25/2020
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/25/2020
• Patient Sequence Number: 1
• Patient Weight: 76
• Date Report Sent to FDA: 11/23/2020