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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 25 25

Device Problems MDRs with this Device Problem Events in those MDRs
Fracture 33 33
Appropriate Term/Code Not Available 21 21
Insufficient Information 19 19
Crack 13 13
Adverse Event Without Identified Device or Use Problem 8 8
Detachment of Device or Device Component 7 7
Burst Container or Vessel 6 6
Material Puncture/Hole 5 5
Fluid/Blood Leak 5 5
Break 4 4
Leak/Splash 3 3
Loose or Intermittent Connection 3 3
Defective Component 2 2
Material Integrity Problem 2 2
Material Frayed 1 1
Restricted Flow rate 1 1
Filtration Problem 1 1
Therapeutic or Diagnostic Output Failure 1 1
Incorrect, Inadequate or Imprecise Result or Readings 1 1
Particulates 1 1
Product Quality Problem 1 1
Tear, Rip or Hole in Device Packaging 1 1
Device Contamination with Chemical or Other Material 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 59 59
No Known Impact Or Consequence To Patient 28 28
Insufficient Information 11 11
No Patient Involvement 2 2
Chemical Exposure 1 1
Pain 1 1
Muscle/Tendon Damage 1 1

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