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

Model Number 46915

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

Event Date 09/05/2023

Event Type  Injury  

Event Description

Medtronic duet draining system attached to the evd(external ventricular drainage) was clamped after nicardipine injection at 1615.At 1700 there was wet area around proximal stopcock.Practitioner flushed line and noted the line was compromised and had separated from hub.

• Brand Name: MEDTRONIC DUET DRAINAGE SYSTEM
• Type of Device: EXTERNAL CEREBROSPINAL FLUID (CSF) DIVERSION
• Manufacturer (Section D): MEDTRONIC NEUROSURGERY
• MDR Report Key: 17728702
• MDR Text Key: 323295096
• Report Number: MW5145533
• Device Sequence Number: 1
• Product Code: PCB
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 09/07/2023

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: 46915
• Device Lot Number: 226571112
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/07/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/11/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 34 YR
• Patient Sex: Female
• Patient Weight: 93 KG
• Patient Ethnicity: Non Hispanic