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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
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
2018 142 157
2019 204 256
2020 147 147
2021 161 161
2022 112 112
2023 17 17

Device Problems MDRs with this Device Problem Events in those MDRs
Fluid/Blood Leak 243 281
Device Contamination with Chemical or Other Material 231 259
Contamination /Decontamination Problem 152 152
Break 39 39
Leak/Splash 30 30
Disconnection 28 28
Detachment of Device or Device Component 12 12
Degraded 9 9
Material Split, Cut or Torn 8 8
Contamination 8 8
Material Puncture/Hole 8 8
Material Rupture 7 7
Crack 7 7
Particulates 6 6
Difficult to Open or Close 6 6
Device Dislodged or Dislocated 6 6
Mechanical Problem 5 5
Component Missing 4 4
Tear, Rip or Hole in Device Packaging 3 3
Defective Component 3 3
Cut In Material 3 3
Failure to Disconnect 3 4
Defective Device 3 3
Material Separation 3 3
Material Perforation 3 3
Loose or Intermittent Connection 3 3
Fracture 3 3
Component Misassembled 3 3
Unexpected Color 2 2
Improper Flow or Infusion 2 2
Device Fell 2 2
Scratched Material 2 2
Material Integrity Problem 2 2
Hole In Material 2 2
Device Slipped 2 2
Product Quality Problem 2 2
Device Difficult to Setup or Prepare 2 2
Decrease in Pressure 2 2
Microbial Contamination of Device 2 2
Obstruction of Flow 1 1
Application Program Problem 1 1
Failure to Advance 1 1
Device Damaged Prior to Use 1 1
Entrapment of Device 1 1
Filling Problem 1 1
Burst Container or Vessel 1 1
Precipitate in Device or Device Ingredient 1 1
Premature Activation 1 1
Misassembled 1 1
Misconnection 1 1
Delivered as Unsterile Product 1 1
Unsealed Device Packaging 1 1
No Flow 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Pressure Problem 1 1
Pumping Problem 1 1
Separation Problem 1 1
Device Contaminated During Manufacture or Shipping 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Fail-Safe Problem 1 1
Device Markings/Labelling Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Patient Involvement 380 434
No Clinical Signs, Symptoms or Conditions 274 274
No Consequences Or Impact To Patient 48 56
No Known Impact Or Consequence To Patient 43 48
Insufficient Information 27 27
No Information 9 9
Air Embolism 2 2
Hypoxia 2 2
Sprain 1 1
Exposure to Body Fluids 1 1
Chemical Exposure 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Baxter Healthcare Corporation II Nov-02-2018
2 Baxter Healthcare Corporation II Jan-11-2018
3 Mckesson Medical-Surgical Inc. Corporate Office II Aug-26-2022
4 Stradis Healthcare II Jan-11-2023
5 The Metrix Company II Oct-01-2019
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