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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
Product CodeBSN
Regulation Number 868.5130
Device Class 2


Premarket Reviews
ManufacturerDecision
PAJUNK GMBH MEDIZINTECHNOLOGIE
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 1 1
2020 1 1
2021 3 3
2022 23 23
2023 18 18
2024 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Disconnection 12 12
Material Fragmentation 9 9
Break 6 6
Fluid/Blood Leak 4 4
Detachment of Device or Device Component 4 4
Crack 3 3
Fracture 2 2
Material Separation 2 2
Defective Component 2 2
Difficult to Open or Close 2 2
Pressure Problem 2 2
Incomplete or Inadequate Connection 1 1
Separation Problem 1 1
Air/Gas in Device 1 1
Device Contaminated During Manufacture or Shipping 1 1
Leak/Splash 1 1
Loose or Intermittent Connection 1 1
Dull, Blunt 1 1
Obstruction of Flow 1 1
Biocompatibility 1 1
Connection Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 31 31
Insufficient Information 7 7
Foreign Body In Patient 3 3
Device Embedded In Tissue or Plaque 2 2
Discomfort 2 2
Neuropathy 2 2
Local Reaction 2 2
Reaction to Medicinal Component of Device 2 2
No Consequences Or Impact To Patient 1 1
Pain 1 1
Inadequate Pain Relief 1 1
Blister 1 1

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