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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device container, i.v.
Product CodeKPE
Regulation Number 880.5025
Device Class 2


Premarket Reviews
ManufacturerDecision
BEIJING L&Z MEDICAL TECHNOLOGY DEVELOPMENT CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
EPIC MEDICAL PTE LTD
  SUBSTANTIALLY EQUIVALENT 1
EPIC MEDICAL PTE. LTD.
  SUBSTANTIALLY EQUIVALENT 1
GILERO, LLC
  SUBSTANTIALLY EQUIVALENT 1
HAEMOTRONIC S.P.A.
  SUBSTANTIALLY EQUIVALENT 1
HAEMOTRONIC, SPA
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2020 147 147
2021 161 161
2022 112 112
2023 127 127
2024 158 158

Device Problems MDRs with this Device Problem Events in those MDRs
Fluid/Blood Leak 231 231
Device Contamination with Chemical or Other Material 190 190
Contamination /Decontamination Problem 63 63
Detachment of Device or Device Component 36 36
Break 29 29
Leak/Splash 27 27
Disconnection 26 26
Material Puncture/Hole 17 17
Contamination 10 10
Material Split, Cut or Torn 9 9
Mechanical Problem 9 9
Degraded 9 9
Crack 8 8
Material Separation 7 7
Air/Gas in Device 7 7
Particulates 6 6
Device Dislodged or Dislocated 6 6
Material Rupture 5 5
Difficult to Open or Close 5 5
Contamination of Device Ingredient or Reagent 4 4
Component Misassembled 4 4
Defective Component 4 4
Fracture 3 3
Component Missing 3 3
No Flow 3 3
Manufacturing, Packaging or Shipping Problem 2 2
Defective Device 2 2
Microbial Contamination of Device 2 2
Scratched Material 2 2
Device Difficult to Setup or Prepare 2 2
Improper Flow or Infusion 2 2
Decrease in Pressure 2 2
Tear, Rip or Hole in Device Packaging 2 2
Product Quality Problem 2 2
Unexpected Color 2 2
Free or Unrestricted Flow 1 1
Failure to Advance 1 1
Protective Measures Problem 1 1
Priming Problem 1 1
Loose or Intermittent Connection 1 1
Failure to Disconnect 1 1
Premature Activation 1 1
Labelling, Instructions for Use or Training Problem 1 1
Material Deformation 1 1
Delivered as Unsterile Product 1 1
Infusion or Flow Problem 1 1
Material Perforation 1 1
Obstruction of Flow 1 1
Material Discolored 1 1
Fail-Safe Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 523 523
No Patient Involvement 103 103
Insufficient Information 44 44
No Consequences Or Impact To Patient 18 18
No Known Impact Or Consequence To Patient 13 13
Air Embolism 2 2
Chemical Exposure 2 2
Hypoxia 2 2
Exposure to Body Fluids 1 1
Awareness during Anaesthesia 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Mckesson Medical-Surgical Inc. Corporate Office II Aug-26-2022
2 Microtek Medical Inc. II Aug-16-2024
3 ROi CPS LLC II Aug-16-2024
4 Stradis Healthcare II Jan-11-2023
5 The Metrix Company II Nov-08-2024
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