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U.S. Department of Health and Human Services

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

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IVERA MEDICAL CUROS; SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
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.
 
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Brand Name
CUROS
Type of Device
SET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
IVERA MEDICAL
2731 loker avenue west
carlsbad CA 92010
MDR Report Key4023072
MDR Text Key15179408
Report Number4023072
Device Sequence Number1
Product Code LKB
Reporter Country CodeUS
Number of Events Reported1
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 Number002-250
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA08/15/2014
Event Location Hospital
Date Report to Manufacturer08/20/2014
Initial Date Manufacturer Received Not provided
Initial Date FDA Received08/15/2014
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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