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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 10 10

Device Problems MDRs with this Device Problem Events in those MDRs
Fracture 32 32
Appropriate Term/Code Not Available 20 20
Crack 13 13
Adverse Event Without Identified Device or Use Problem 8 8
Insufficient Information 7 7
Detachment of Device or Device Component 7 7
Burst Container or Vessel 6 6
Fluid/Blood Leak 5 5
Material Puncture/Hole 5 5
Break 4 4
Leak/Splash 3 3
Loose or Intermittent Connection 3 3
Material Integrity Problem 2 2
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
Particulates 1 1
Material Frayed 1 1
Restricted Flow rate 1 1
Therapeutic or Diagnostic Output Failure 1 1
No Apparent Adverse Event 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 45 45
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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