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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC, INC. DLP; CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
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MEDTRONIC, INC. DLP; CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS Back to Search Results
Catalog Number 66118
Device Problem Break (1069)
Patient Problem Foreign Body In Patient (2687)
Event Date 05/30/2020
Event Type  malfunction  
Event Description
Cannula used for bypass during liver transplant broke while in patient's left groin.Item was removed and sent with packaging to implant coordinator.Product name: 18g single stage venous cannula.Manufacturer: medtronic.Reference number: 66118.Lot: 2079120488.
 
Event Description
Cannula used for bypass during liver transplant broke while in patient's left groin.Item was removed and sent with packaging to implant coordinator.Product name: 18g single stage venous cannula.Manufacturer: medtronic.Reference number: (b)(4).Lot: 2079120488.
 
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Brand Name
DLP
Type of Device
CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
Manufacturer (Section D)
MEDTRONIC, INC.
4600 nathan lane north
plymouth MN 55442
MDR Report Key10183667
MDR Text Key196107668
Report Number10183667
Device Sequence Number1
Product Code DWF
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Type of Report Initial,Followup
Report Date 06/01/2020
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 No Information
Device Catalogue Number66118
Device Lot Number2079120488
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA06/01/2020
Event Location Hospital
Date Report to Manufacturer06/23/2020
Initial Date Manufacturer Received Not provided
Initial Date FDA Received06/23/2020
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received11/16/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age17520 DA
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