MAUDE Adverse Event Report: TRUECARE BIOMEDIX / US INFUSION INC. D/B/A TRUECARE BIOMEDIX-USA GVS EASYDROP FLOW REGULATOR; SET, ADMINISTRATION, INTRAVASCULAR

Model Number TCBINF033G

Device Problem Excess Flow or Over-Infusion (1311)

Patient Problem Insufficient Information (4580)

Event Date 02/08/2023

Event Type  malfunction  

Event Description

Patients 1 hour infusion infused over 35-40 minutes.The infusion volume is 100 ml, and the rate-controlled tubing was set to 100 ml/hr.

• Brand Name: GVS EASYDROP FLOW REGULATOR
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): TRUECARE BIOMEDIX / US INFUSION INC. D/B/A TRUECARE BIOMEDIX-USA; south miami FL 33143
• MDR Report Key: 16399405
• MDR Text Key: 309911883
• Report Number: MW5115032
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/16/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: TCBINF033G
• Device Lot Number: 21087C1211
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 25 YR
• Patient Sex: Female