MAUDE Adverse Event Report: IMEDICAL DEVICES FLOW REGULATOR IV SET; SET, ADMINISTRATION, INTRAVASCULAR

Model Number IMS033G

Device Problems Fluid/Blood Leak (1250); Infusion or Flow Problem (2964)

Patient Problem Insufficient Information (4580)

Event Date 10/12/2021

Event Type  malfunction  

Event Description

Imedical devices ims033g flow regulator iv set, lot #11240521 defects with collar not attaching correctly causing leakage or flow issues.Fda safety report id # (b)(4).

• Brand Name: IMEDICAL DEVICES FLOW REGULATOR IV SET
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• MDR Report Key: 12682406
• MDR Text Key: 278534312
• Report Number: MW5104898
• Device Sequence Number: 1
• Product Code: FPA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Type of Report: Initial
• Report Date: 10/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/21/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: IMS033G
• Device Lot Number: 11240521
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 70 YR
• Patient Weight: 68