• 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 pump, infusion, elastomeric
Regulation Description Infusion pump.
Product CodeMEB
Regulation Number 880.5725
Device Class 2


Premarket Reviews
ManufacturerDecision
HALYARD HEALTH
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Fluid Leak 1740
Filling Problem 1473
Reservoir 990
Material Rupture 885
No Flow 803
Inaccurate Flow rate 583
Port 488
Infusion or Flow Problem 444
Excess Flow or Over-Infusion 358
Device Contamination with Chemical or Other Material 335
Cap 327
Failure to Infuse 258
Tube 207
Leak / Splash 158
Break 153
Disconnection 140
Connector 113
Adverse Event Without Identified Device or Use Problem 112
Housing 63
Device Operates Differently Than Expected 56
Component Missing 51
Loose or Intermittent Connection 39
Insufficient Flow or Under Infusion 39
Regulator 33
Detachment Of Device Component 26
Failure to Prime 25
Crack 23
Filter 20
Reflux within Device 18
Failure to Deliver 17
Improper Flow or Infusion 14
Material Separation 13
Material Deformation 13
Improper or Incorrect Procedure or Method 11
Resistor 8
Detachment of Device or device Component 8
Physical Resistance / Sticking 7
Cut In Material 7
Material Puncture / Hole 7
Misconnection 7
Split 6
Material Integrity Problem 6
Scratched Material 6
Contamination / decontamination Problem 5
Luer Valve 4
Mechanical Problem 4
Device Contaminated during manufacture or shipping 4
Catheter 4
Fitting Problem 3
Partial Blockage 3
Adapter (Adaptor) 3
Clamp 3
Retraction Problem 3
Material Split, Cut or Torn 3
Device Difficult to Setup or Prepare 3
Appropriate Term/Code Not Available 3
Backflow 3
Burst Container or Vessel 3
Device Markings / Labelling Problem 2
Manufacturing, Packaging or Shipping Problem 2
Stretched 2
Defective Component 2
Fracture 2
Material Perforation 2
Hole In Material 2
Connection Problem 2
Device Operational Issue 2
Shelf Life Exceeded 2
Device Dislodged or Dislocated 2
Volume Accuracy Problem 2
Bent 2
Torn Material 2
Insufficient Information 1
Melted 1
Delivered as Unsterile Product 1
Sticking 1
Defective Device 1
Battery Problem 1
Mechanical Jam 1
Packaging Problem 1
Post 1
Loss of or Failure to Bond 1
Migration or Expulsion of Device 1
Misassembled 1
Use of Device Problem 1
Electro-Static Discharge 1
Complete Blockage 1
Decoupling 1
Application Program Problem: Medication Error 1
Battery 1
No Apparent Adverse Event 1
Material Opacification 1
Particulates 1
Flaked 1
Difficult to Open or Close 1
Precipitate in Device or device Ingredient 1
Valve 1
Circuit Failure 1
Activation Problem 1
Device Displays Incorrect Message 1
Total Device Problems 10197

Recalls
Manufacturer Recall Class Date Posted
1 Arrow International Inc II Feb-25-2019
2 Leventon S. A. U. II Aug-23-2019

-
-