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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
GILERO, LLC
  SUBSTANTIALLY EQUIVALENT 1
HAEMOTRONIC S.P.A.
  SUBSTANTIALLY EQUIVALENT 1
HAEMOTRONIC, SPA
  SUBSTANTIALLY EQUIVALENT 1
HEALTH CARE TECHNOLOGIES
  SUBSTANTIALLY EQUIVALENT 1
INTERNATIONAL MEDICAL INDUSTRIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
VALMED SRL
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 204 256
2020 147 147
2021 161 161
2022 112 112
2023 127 127
2024 63 63

Device Problems MDRs with this Device Problem Events in those MDRs
Fluid/Blood Leak 242 270
Device Contamination with Chemical or Other Material 211 234
Contamination /Decontamination Problem 152 152
Break 33 33
Leak/Splash 33 33
Disconnection 28 28
Detachment of Device or Device Component 26 26
Material Puncture/Hole 15 15
Contamination 10 10
Crack 9 9
Mechanical Problem 9 9
Particulates 9 9
Material Split, Cut or Torn 9 9
Degraded 8 8
Material Rupture 7 7
Material Separation 7 7
Device Dislodged or Dislocated 6 6
Difficult to Open or Close 5 5
Component Misassembled 4 4
Defective Component 4 4
Contamination of Device Ingredient or Reagent 4 4
Defective Device 3 3
Component Missing 3 3
Tear, Rip or Hole in Device Packaging 3 3
Fracture 3 3
No Flow 3 3
Manufacturing, Packaging or Shipping Problem 2 2
Improper Flow or Infusion 2 2
Unexpected Color 2 2
Scratched Material 2 2
Device Difficult to Setup or Prepare 2 2
Decrease in Pressure 2 2
Microbial Contamination of Device 2 2
Product Quality Problem 2 2
Device Slipped 2 2
Material Perforation 1 1
Device Damaged Prior to Use 1 1
Incorrect, Inadequate or Imprecise Result or Readings 1 1
Obstruction of Flow 1 1
Failure to Advance 1 1
Failure to Disconnect 1 2
Application Program Problem 1 1
Precipitate in Device or Device Ingredient 1 1
Premature Activation 1 1
Delivered as Unsterile Product 1 1
Unsealed Device Packaging 1 1
Loose or Intermittent Connection 1 1
Labelling, Instructions for Use or Training Problem 1 1
Entrapment of Device 1 1
Filling Problem 1 1
Burst Container or Vessel 1 1
Infusion or Flow Problem 1 1
Free or Unrestricted Flow 1 1
Fail-Safe Problem 1 1
Device Markings/Labelling Problem 1 1
Material Deformation 1 1
Material Integrity Problem 1 1
Pressure Problem 1 1
Pumping Problem 1 1
Device Fell 1 1
Priming Problem 1 1
Separation Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 436 436
No Patient Involvement 264 303
Insufficient Information 38 38
No Consequences Or Impact To Patient 37 45
No Known Impact Or Consequence To Patient 35 40
No Information 2 2
Hypoxia 2 2
Air Embolism 2 2
Exposure to Body Fluids 1 1
Chemical Exposure 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Mckesson Medical-Surgical Inc. Corporate Office II Aug-26-2022
2 Stradis Healthcare II Jan-11-2023
3 The Metrix Company II Oct-01-2019
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