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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device container, empty, for collection & processing of blood & blood components
Product CodeKSR
Regulation Number 864.9100
Device Class 2


Premarket Reviews
ManufacturerDecision
FRESENIUS KABI AG
  SUBSTANTIALLY EQUIVALENT 3
TERUMO BCT, INC
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 9 9
2020 21 21
2021 17 17
2022 11 11
2023 20 20
2024 4 4

Device Problems MDRs with this Device Problem Events in those MDRs
Fracture 30 30
Appropriate Term/Code Not Available 15 15
Crack 12 12
Insufficient Information 7 7
Detachment of Device or Device Component 6 6
Material Puncture/Hole 5 5
Burst Container or Vessel 5 5
Fluid/Blood Leak 5 5
Break 4 4
Loose or Intermittent Connection 3 3
Leak/Splash 2 2
Material Integrity Problem 2 2
Adverse Event Without Identified Device or Use Problem 2 2
Therapeutic or Diagnostic Output Failure 1 1
No Apparent Adverse Event 1 1
Material Frayed 1 1
Restricted Flow rate 1 1
Particulates 1 1
Filtration Problem 1 1
Product Quality Problem 1 1
Incorrect, Inadequate or Imprecise Result or Readings 1 1
Defective Component 1 1
Tear, Rip or Hole in Device Packaging 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 39 39
No Known Impact Or Consequence To Patient 28 28
Insufficient Information 10 10
No Patient Involvement 2 2
Muscle/Tendon Damage 1 1
Pain 1 1
Chemical Exposure 1 1

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