MAUDE Adverse Event Report: REPRO-MED SYSTEMS, INC DBA KORU MEDICAL SYSTEMS INTEGRATED CATCH-UP FREEDOM SYRINGE DRIVER INFUSION SYSTEM

Model Number	FREEDOMEDGE
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported a patient was able to start an infusion ommitting the use of flow rate tubing and directly connecting the needle set to the syringe while utilizing the freedomedge syringe driver.

• Brand Name: INTEGRATED CATCH-UP FREEDOM SYRINGE DRIVER INFUSION SYSTEM
• Common Device Name: INTEGRATED CATCH-UP FREEDOM SYRINGE DRIVER INFUSION SYSTEM
• Manufacturer (Section D): REPRO-MED SYSTEMS, INC DBA KORU MEDICAL SYSTEMS; 24 carpenter road; chester, ny
• MDR Report Key: 9905477
• Report Number: 1318360-2020-00001
• Device Sequence Number: 2318528
• Product Code: PKP
• UDI-Device Identifier: 00659443000018
• UDI-Public: 00659443000018
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K162613
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/31/2020

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: Lay User/Patient
• Device Model Number: FREEDOMEDGE
• Device Catalogue Number: F10020
• Device Lot Number: E.79669
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/07/2020
• Initial Report FDA Received Date: 03/31/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1