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

Model Number DLP3D76R1

Device Problem Break (1069)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/23/2019

Event Type  malfunction  

Event 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.

• Type of Device: CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MEDTRONIC, INC.; 710 medtronic parkway; minneapolis MN 55432 5604
• MDR Report Key: 8300825
• MDR Text Key: 134861554
• Report Number: 8300825
• Device Sequence Number: 1
• Product Code: DWF
• UDI-Device Identifier: 00721902835827
• UDI-Public: (01)00721902835827
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 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
• Device Operator: No Information
• Device Model Number: DLP3D76R1
• Device Lot Number: 214823031
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/24/2019
• Event Location: Hospital
• Date Report to Manufacturer: 02/04/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/04/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 23725 DA
• Patient Weight: 83