MAUDE Adverse Event Report: IVERA MEDICAL CUROS; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number 002-250

Device Problem Break (1069)

Patient Problem No Information (3190)

Event Date 08/03/2014

Event Type  malfunction  

Event Description

Curos cap broke apart.Little green ring stayed on the iv port when rn took the cap off.This apparently happened twice.

• Brand Name: CUROS
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): IVERA MEDICAL; 2731 loker avenue west; carlsbad CA 92010
• MDR Report Key: 4023072
• MDR Text Key: 15179408
• Report Number: 4023072
• Device Sequence Number: 1
• Product Code: LKB
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 08/15/2014

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
• Device Operator: Invalid Data
• Device Catalogue Number: 002-250
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/15/2014
• Event Location: Hospital
• Date Report to Manufacturer: 08/20/2014
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/15/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1