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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
Regulation Description Empty container for the collection and processing of blood and blood components.
Product CodeKSR
Regulation Number 864.9100
Device Class 2


Premarket Reviews
ManufacturerDecision
FRESENIUS KABI AG
  SUBSTANTIALLY EQUIVALENT 2
HAEMONETICS MANUFACTURING INC.
  SUBSTANTIALLY EQUIVALENT 1
TERUMO BCT, INC
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2021 17 20
2022 11 11
2023 20 20
2024 25 25
2025 11 11
2026 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
Insufficient Device Problem Information 30 30
Adverse Event Without Identified Device or Use Problem 29 29
Appropriate Device Problem Term/Code Not Available 21 21
Fracture 19 19
Crack 8 8
Detachment of Device or Device Component 6 6
Burst Container or Vessel 4 4
Fluid/Blood Leak 3 3
Break 2 2
Loose or Intermittent Connection 2 2
Leak/Splash 1 1
Material Puncture/Hole 1 1
Defective Component 1 1
Defective Device 1 1
Contamination 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 72 72
Insufficient Information 11 14
No Known Impact Or Consequence To Patient 2 2
Chemical Exposure 1 1
Muscle/Tendon Damage 1 1

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