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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device filter, conduction, anesthetic
Regulation Description Anesthesia conduction filter.
Product CodeBSN
Regulation Number 868.5130
Device Class 2

MDR Year MDR Reports MDR Events
2021 3 4
2022 23 23
2023 18 18
2024 11 11
2025 6 6
2026 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Disconnection 15 15
Material Fragmentation 9 10
Break 8 8
Fluid/Blood Leak 6 6
Crack 4 4
Detachment of Device or Device Component 3 3
Pressure Problem 2 2
Difficult to Insert 2 2
Obstruction of Flow 2 2
Gas/Air Leak 2 2
Partial Blockage 2 2
Material Separation 2 2
Fracture 2 2
Difficult to Open or Close 2 2
Leak/Splash 1 1
Device Contaminated During Manufacture or Shipping 1 1
Separation Problem 1 1
Mechanical Problem 1 1
Defective Component 1 1
Material Integrity Problem 1 1
Contamination 1 1
Air/Gas in Device 1 1
Connection Problem 1 1
Loose or Intermittent Connection 1 1
Dull, Blunt 1 1
Biocompatibility 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 47 47
Insufficient Information 8 9
Foreign Body In Patient 3 4
Device Embedded In Tissue or Plaque 2 2
Neuropathy 2 2
Local Reaction 2 2
Discomfort 2 2
Reaction to Medicinal Component of Device 2 2
Rupture 1 1
Blister 1 1

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