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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.
Regulation Description I.V. container.
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 3
FRESENIUS KABI AG
  SUBSTANTIALLY EQUIVALENT 1
GILERO, LLC
  SUBSTANTIALLY EQUIVALENT 1
HAEMOTRONIC S.P.A.
  SUBSTANTIALLY EQUIVALENT 1
TECHNOFLEX SAS.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2021 162 165
2022 112 113
2023 127 128
2024 158 158
2025 225 225

Device Problems MDRs with this Device Problem Events in those MDRs
Fluid/Blood Leak 224 225
Device Contamination with Chemical or Other Material 171 171
Contamination /Decontamination Problem 157 157
Detachment of Device or Device Component 43 43
Leak/Splash 25 25
Disconnection 23 23
Break 18 20
Material Puncture/Hole 18 18
Contamination 18 18
Mechanical Problem 13 13
Particulates 13 13
Material Split, Cut or Torn 12 12
Air/Gas in Device 9 9
Contamination of Device Ingredient or Reagent 7 7
Material Separation 7 7
Degraded 7 7
Crack 6 6
No Flow 5 5
Failure to Disconnect 5 5
Defective Component 5 5
Device Dislodged or Dislocated 5 6
Defective Device 4 4
Component Missing 4 4
Product Quality Problem 3 4
Fracture 3 3
Material Rupture 3 3
Device Difficult to Setup or Prepare 3 4
Material Fragmentation 3 3
Material Integrity Problem 3 3
Incomplete or Inadequate Connection 3 3
Fail-Safe Problem 2 2
Scratched Material 2 2
Microbial Contamination of Device 2 2
Improper Flow or Infusion 2 2
Decrease in Pressure 2 2
Material Perforation 2 2
Infusion or Flow Problem 2 2
Manufacturing, Packaging or Shipping Problem 2 3
Unexpected Color 2 2
Loose or Intermittent Connection 2 2
Free or Unrestricted Flow 2 2
Nonstandard Device 1 1
Protective Measures Problem 1 1
Connection Problem 1 1
Priming Problem 1 1
Component Misassembled 1 1
Difficult to Open or Close 1 1
No Apparent Adverse Event 1 1
Improper or Incorrect Procedure or Method 1 1
Premature Activation 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 729 734
Insufficient Information 46 46
No Patient Involvement 3 3
Air Embolism 2 2
Chemical Exposure 2 2
Hypoxia 2 2
No Consequences Or Impact To Patient 2 2
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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