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

Device Problem Excess Flow or Over-Infusion (1311)

Patient Problem Overdose (1988)

Event Date 11/24/2019

Event Type  malfunction  

Event Description

Mw 5091360 was received via mail.Pharmacist reported nurse had trouble loading the freedom pump for infusion.The patient received the entire infusion in 10 minutes.The pharmacist indicated the infusion time should have been 90 minutes.

• Brand Name: INTEGRATED CATCH-UP FREEDOM SYRINGE DRIVER INFUSION SYSTEM
• Type of Device: INTEGRATED CATCH-UP FREEDOM SYRINGE DRIVER INFUSION SYSTEM
• Manufacturer (Section D): REPRO-MED SYSTEMS, INC.; 24 carpenter road; chester NY 10918
• Manufacturer (Section G): REPRO-MED SYSTEMS, INC.; 24 carpenter road; chester NY 10918
• Manufacturer Contact: susan raleigh ; 24 carpenter road; chester, NY 10918 ; 8454692042
• MDR Report Key: 9483902
• MDR Text Key: 219764331
• Report Number: 1318360-2019-00005
• Device Sequence Number: 1
• Product Code: PKP
• Combination Product (y/n): N
• PMA/PMN Number: K162613
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial
• Report Date: 12/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/16/2019
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1