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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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New Search show TPLC since Back to Search Results
Device filter, conduction, anesthetic
Product CodeBSN
Regulation Number 868.5130
Device Class 2


Premarket Reviews
ManufacturerDecision
PAJUNK GMBH MEDIZINTECHNOLOGIE
  SUBSTANTIALLY EQUIVALENT 1
  1.  K190663  Epidural MiniFilter LUER 80369-7, Epidural MiniFil ...

MDR Year MDR Reports MDR Events
2018 1 1
2019 1 1
2020 1 1
2021 3 3
2022 13 13

Device Problems MDRs with this Device Problem Events in those MDRs
Disconnection 9 9
Fluid Leak 3 3
Material Fragmentation 1 1
Leak/Splash 1 1
Defective Component 1 1
Dull, Blunt 1 1
Obstruction of Flow 1 1
Detachment of Device or Device Component 1 1
Difficult to Open or Close 1 1
Device Contaminated During Manufacture or Shipping 1 1
Incomplete or Inadequate Connection 1 1
Break 1 1
Crack 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 15 15
Pain 1 1
No Consequences Or Impact To Patient 1 1
Inadequate Pain Relief 1 1
Foreign Body In Patient 1 1
No Known Impact Or Consequence To Patient 1 1
Insufficient Information 1 1

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