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

Model Number 46915

Device Problems Material Separation (1562); No Flow (2991)

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

Event Date 06/28/2023

Event Type  Injury  

Event Description

The medtroinc duet external drainage system was attached to the patient's evd(external ventricular drain) on (b)(6) 2023.On (b)(6) 2023 the drainage system was not draining and within the hours it was assessed by nursing and neurosurgery.The patient line was found to have separated from it hub that was still secured to the stop clock.There was no evidence of force and evd sutures were intact.

• Brand Name: DUET EXTERNAL DRAINAGE SYSTEM
• Type of Device: EXTERNAL CEREBROSPINAL FLUID (CSF) DIVERSION
• Manufacturer (Section D): MEDTRONIC NEUROSURGERY
• MDR Report Key: 17268457
• MDR Text Key: 318589904
• Report Number: MW5119136
• 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: 06/30/2023

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 Expiration Date: 06/29/2023
• Device Model Number: 46915
• Device Lot Number: 226634688
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/05/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 60 YR
• Patient Sex: Male
• Patient Weight: 63 KG
• Patient Race: White