MAUDE Adverse Event Report: MEDTRONIC PS MEDICAL, INC. DUET®; EXTERNAL CEREBROSPINAL FLUID (CSF) DIVERSION

Model Number 46914

Patient Problem Unspecified Infection (1930)

Event Date 01/10/2024

Event Type  malfunction  

Event Description

Three instances of external ventricular drainage systems (evd) separating at the luer lock and connecting tubing leading to a large risk of infection and re-insertion.

• Brand Name: DUET®
• Type of Device: EXTERNAL CEREBROSPINAL FLUID (CSF) DIVERSION
• Manufacturer (Section D): MEDTRONIC PS MEDICAL, INC.; 200 medtronic drive; lafayette CO 80026
• MDR Report Key: 18825982
• MDR Text Key: 336776193
• Report Number: 18825982
• Device Sequence Number: 1
• Product Code: PCB
• UDI-Device Identifier: 00763000624774
• UDI-Public: (01)00763000624774
• 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: 01/12/2024

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: 46914
• Device Lot Number: 227007687
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/12/2024
• Event Location: Hospital
• Date Report to Manufacturer: 03/04/2024
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/04/2024
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 20 YR
• Patient Sex: Female
• Patient Weight: 61 KG