MAUDE Adverse Event Report: MEDTRONIC, INC.; CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS

Model Number	DLP3D76R1
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/23/2019
Type of Reportable Event	Malfunction
Event or Problem Description
At the start of the day, the cardiac cannula kit was opened to the sterile field.The scrub technician was examining the kit and found the two stage venous cannula tip was chipped.The cannula was removed from the field and replaced.

• Common Device Name: CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MEDTRONIC, INC.; 710 medtronic parkway; minneapolis MN 55432 5604
• MDR Report Key: 8300825
• Report Number: 8300825
• Device Sequence Number: 53721
• Product Code: DWF
• UDI-Device Identifier: 00721902835827
• UDI-Public: (01)00721902835827
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 01/24/2019
• Report Date (Section F): 01/24/2019

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
• Operator of Device: No Information
• Device Model Number: DLP3D76R1
• Device Lot Number: 214823031
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 02/04/2019
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/04/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 83
• Date Report Sent to FDA: 01/24/2019