inforMED
InjuryPCB

DUET EXTERNAL DRAINAGE SYSTEM

Received Jul 5, 2023 · Event occurred Jun 28, 2023

Report MW5119136 · MDR key 17268457

Device

Generic name

External Cerebrospinal Fluid (csf) Diversion

Model number

46915

Lot number

226634688

Product problems

  • Material Separation
  • No Flow

Patient

60 YR · Male

  • No Clinical Signs, Symptoms or Conditions
  • No Clinical Signs, Symptoms or Conditions

Narrative

Description of Event or Problem

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.