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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device catheter, ventricular (containing antibiotic or antimicrobial agents)
Regulation Description Ventricular catheter.
Definition Used to gain access to the cavities of the brain for injection of material into or removal of material from the brain.
Product CodeNHC
Regulation Number 882.4100
Device Class 2

MDR Year MDR Reports MDR Events
2019 2 2
2020 9 9
2022 1 1
2024 4 4
2025 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
Fluid/Blood Leak 9 9
Break 3 3
Device Contaminated During Manufacture or Shipping 2 2
Material Separation 2 2
Fracture 2 2
Material Split, Cut or Torn 1 1
Entrapment of Device 1 1
Insufficient Information 1 1
Difficult to Remove 1 1
Detachment of Device or Device Component 1 1
Appropriate Term/Code Not Available 1 1
Flaked 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 8 8
No Clinical Signs, Symptoms or Conditions 5 5
Pain 2 2
Foreign Body In Patient 1 1
No Patient Involvement 1 1
Cerebrospinal Fluid Leakage 1 1
Device Embedded In Tissue or Plaque 1 1

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