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

Model Number DLP3D76R1

Device Problem Break (1069)

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

Event Date 12/15/2018

Event Type  malfunction  

Event Description

When handing off the venous cannula to be used, it was noted that a piece was broken off the top.The piece was located and a new cannula was opened.Risk was notified by message on the phone.The device was red bagged and brought to the front desk for pick up.

• Brand Name: NA
• Type of Device: CATHETER, CANNULA AND TUBING
• Manufacturer (Section D): MEDTRONIC, INC.; 7611 northland dr; minneapolis MN 55428
• MDR Report Key: 8189208
• MDR Text Key: 131157995
• Report Number: 8189208
• Device Sequence Number: 1
• Product Code: DWF
• 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: 12/17/2018

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: Health Professional
• 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: 12/17/2018
• Event Location: Hospital
• Date Report to Manufacturer: 12/21/2018
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/21/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 25550 DA