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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
FENWAL INC
  SUBSTANTIALLY EQUIVALENT 1
FRESENIUS KABI AG
  SUBSTANTIALLY EQUIVALENT 4
HAEMONETICS MANUFACTURING INC.
  SUBSTANTIALLY EQUIVALENT 2
ORIGEN BIOMEDICAL
  SUBSTANTIALLY EQUIVALENT 2
PURIBLOOD MEDICAL CO. LTD.
  SUBSTANTIALLY EQUIVALENT 1
TERUMO BCT, INC
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2014 11 11
2015 8 8
2016 5 5
2017 4 4
2018 3 3
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 34 34
Appropriate Term/Code Not Available 20 20
Crack 18 18
Adverse Event Without Identified Device or Use Problem 10 10
Leak/Splash 8 8
Detachment of Device or Device Component 8 8
Fluid/Blood Leak 8 8
Insufficient Information 8 8
Break 6 6
Burst Container or Vessel 6 6
Material Puncture/Hole 5 5
Material Integrity Problem 4 4
Loose or Intermittent Connection 3 3
Defective Component 2 2
Device Disinfection Or Sterilization Issue 2 2
Component Missing 2 2
Particulates 2 2
Device Operates Differently Than Expected 2 2
Improper or Incorrect Procedure or Method 2 2
Material Frayed 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Therapeutic or Diagnostic Output Failure 1 1
Product Quality Problem 1 1
Contamination of Device Ingredient or Reagent 1 1
Tear, Rip or Hole in Device Packaging 1 1
No Apparent Adverse Event 1 1
Free or Unrestricted Flow 1 1
Material Rupture 1 1
Material Deformation 1 1
Hole In Material 1 1
Device Markings/Labelling Problem 1 1
Restricted Flow rate 1 1
Filtration Problem 1 1
Scratched Material 1 1
Incorrect, Inadequate or Imprecise Result or Readings 1 1
Failure To Adhere Or Bond 1 1
Use of Device Problem 1 1
Protective Measures Problem 1 1
Human-Device Interface Problem 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 40 40
Insufficient Information 10 10
No Information 8 8
No Patient Involvement 5 5
Unspecified Infection 2 2
Needle Stick/Puncture 2 2
Abdominal Pain 1 1
Death 1 1
No Code Available 1 1
Infection, Indirect 1 1
Bone Fracture(s) 1 1
Chemical Exposure 1 1
Osteopenia/ Osteoporosis 1 1
Disseminated Intravascular Coagulation (DIC) 1 1
Pain 1 1
Muscle/Tendon Damage 1 1
Renal Failure 1 1
Tachycardia 1 1
Toxicity 1 1
Hemorrhage/Bleeding 1 1
No Consequences Or Impact To Patient 1 1
Thromboembolism 1 1
Low Blood Pressure/ Hypotension 1 1
Respiratory Failure 1 1

Recalls
Manufacturer Recall Class Date Posted
1 DeRoyal Industries Inc II Apr-12-2012
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