• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search show TPLC since Back to Search Results
Device container, i.v.
Product CodeKPE
Regulation Number 880.5025
Device Class 2


Premarket Reviews
ManufacturerDecision
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

Device Problems MDRs with this Device Problem Events in those MDRs
Fluid/Blood Leak 237 275
Device Contamination with Chemical or Other Material 230 258
Contamination /Decontamination Problem 152 152
Break 39 39
Leak/Splash 30 30
Disconnection 25 25
Detachment of Device or Device Component 10 10
Degraded 9 9
Material Puncture/Hole 8 8
Contamination 8 8
Material Rupture 7 7
Material Split, Cut or Torn 7 7
Difficult to Open or Close 6 6
Particulates 6 6
Mechanical Problem 5 5
Crack 5 5
Device Dislodged or Dislocated 5 5
Component Missing 4 4
Cut In Material 3 3
Material Perforation 3 3
Defective Component 3 3
Material Separation 3 3
Loose or Intermittent Connection 3 3
Fracture 3 3
Failure to Disconnect 3 4
Defective Device 3 3
Component Misassembled 3 3
Improper Flow or Infusion 2 2
Device Fell 2 2
Unexpected Color 2 2
Material Integrity Problem 2 2
Hole In Material 2 2
Decrease in Pressure 2 2
Device Slipped 2 2
Product Quality Problem 2 2
Microbial Contamination of Device 2 2
Tear, Rip or Hole in Device Packaging 2 2
Obstruction of Flow 1 1
Failure to Advance 1 1
Device Damaged Prior to Use 1 1
Filling Problem 1 1
Burst Container or Vessel 1 1
Misassembled 1 1
Misconnection 1 1
Delivered as Unsterile Product 1 1
Unsealed Device Packaging 1 1
Precipitate in Device or Device Ingredient 1 1
Premature Activation 1 1
Device Difficult to Setup or Prepare 1 1
No Flow 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Pressure Problem 1 1
Pumping Problem 1 1
Scratched Material 1 1
Fail-Safe Problem 1 1
Device Contaminated During Manufacture or Shipping 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Application Program 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 259 259
No Consequences Or Impact To Patient 48 56
No Known Impact Or Consequence To Patient 43 48
Insufficient Information 25 25
No Information 9 9
Hypoxia 2 2
Air Embolism 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
-
-