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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC, INC. MEDTRONIC MC2 TWO STAGE VENOUS CANNULA
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MEDTRONIC, INC. MEDTRONIC MC2 TWO STAGE VENOUS CANNULA Back to Search Results
Lot Number 2017110530
Device Problems Break (1069); Detachment Of Device Component (1104); Unknown (for use when the device problem is not known) (2204); Device Or Device Fragments Location Unknown (2590)
Patient Problem Device Embedded In Tissue or Plaque (3165)
Event Date 01/16/2018
Event Type  malfunction  
Event Description
Risk was notified that the patient was having an acb and when the surgeon was cannulating the heart for the venous canula placement he noticed a small plastic piece broken off of the cannula.The cannula was replaced with a new cannula.Unsure when the piece was broken.The surgeon looked for the piece and unable to locate it.Discharged home on (b)(6) 2018.
 
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Brand Name
MEDTRONIC MC2 TWO STAGE VENOUS CANNULA
Type of Device
VENOUS CANNULA
Manufacturer (Section D)
MEDTRONIC, INC.
3576 unocal pl.
santa rosa CA 95403
MDR Report Key7240887
MDR Text Key99188760
Report Number7240887
Device Sequence Number1
Product Code DWF
Combination Product (y/n)N
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 01/23/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/05/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date11/30/2020
Device Lot Number2017110530
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA01/23/2018
Distributor Facility Aware Date01/16/2018
Event Location Hospital
Date Report to Manufacturer01/23/2018
Was Device Evaluated by Manufacturer? No Information
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Age75 YR
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