MAUDE Adverse Event Report: MEDTRONIC NEUROSURGERY DUET; EXTERNAL CEREBROSPINAL FLUID (CSF) DIVERSION

Model Number 46912

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/09/2023

Event Type  malfunction  

Event Description

When changing the bag, the top part of the bag that screws into the collection system broke off.The retained portion was difficult to remove, but was eventually able to be removed.Connection point was cleaned, and new bag was attached.

• Brand Name: DUET
• Type of Device: EXTERNAL CEREBROSPINAL FLUID (CSF) DIVERSION
• Manufacturer (Section D): MEDTRONIC NEUROSURGERY; 5290 california ave; irvine CA 92617
• MDR Report Key: 18101995
• MDR Text Key: 327741442
• Report Number: 18101995
• Device Sequence Number: 1
• Product Code: PCB
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 08/14/2023

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: 46912
• Device Catalogue Number: 46912
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/14/2023
• Event Location: Hospital
• Date Report to Manufacturer: 11/09/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/09/2023
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Sex: Female