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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device closed antineoplastic and hazardous drug reconstitution and transfer system
Regulation Description Intravascular administration set.
Definition Reconstitute and transfer antineoplastic and other hazardous drugs in healthcare setting indicated to reduce exposure of healthcare personnel to chemotherapy agents in healthcare setting.
Product CodeONB
Regulation Number 880.5440
Device Class 2


Premarket Reviews
ManufacturerDecision
BECTON, DICKINSON AND COMPANY
  SUBSTANTIALLY EQUIVALENT 2
EPIC MEDICAL PTE. LTD.
  SUBSTANTIALLY EQUIVALENT 1
EQUASHIELD MEDICAL LTD.
  SUBSTANTIALLY EQUIVALENT 1
ICU MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
ICU MEDICAL INC
  SUBSTANTIALLY EQUIVALENT 1
ICU MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
J & J SOLUTIONS, INC. D/B/A/ CORVIDA MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
JMS NORTH AMERICA CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
SIMPLIVIA HEALTHCARE LTD.
  SUBSTANTIALLY EQUIVALENT 3
TEVA MEDICAL LTD., MIGADA PLANT
  SUBSTANTIALLY EQUIVALENT 2
YUKON MEDICAL, LLC
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2017 66 66
2018 228 228
2019 461 461
2020 441 441
2021 549 549

Device Problems MDRs with this Device Problem Events in those MDRs
Leak/Splash 764 764
Fluid Leak 343 343
Device Contamination with Chemical or Other Material 220 220
Break 84 84
Infusion or Flow Problem 70 70
Difficult or Delayed Activation 48 48
Disconnection 46 46
Material Separation 37 37
Detachment of Device or Device Component 36 36
Crack 16 16
Contamination /Decontamination Problem 15 15
Connection Problem 12 12
Device Operates Differently Than Expected 7 7
Complete Blockage 7 7
Misconnection 6 6
Particulates 6 6
Retraction Problem 6 6
Material Protrusion/Extrusion 6 6
Packaging Problem 6 6
Physical Resistance/Sticking 6 6
Incomplete or Inadequate Connection 5 5
Appropriate Term/Code Not Available 5 5
Material Deformation 5 5
Occlusion Within Device 5 5
Loose or Intermittent Connection 5 5
Inflation Problem 5 5
Mechanical Problem 4 4
Detachment Of Device Component 4 4
Deflation Problem 4 4
Structural Problem 4 4
Device Slipped 4 4
Use of Device Problem 4 4
Fitting Problem 4 4
Device Damaged Prior to Use 4 4
Defective Component 4 4
Protective Measures Problem 4 4
Separation Problem 4 4
Activation Failure 3 3
Improper Flow or Infusion 3 3
Free or Unrestricted Flow 3 3
Device Markings/Labelling Problem 3 3
Failure to Deliver 3 3
Volume Accuracy Problem 3 3
Product Quality Problem 3 3
Defective Device 3 3
Material Fragmentation 3 3
Unintended Ejection 3 3
Moisture Damage 3 3
Delivered as Unsterile Product 2 2
Material Puncture/Hole 2 2
Precipitate in Device or Device Ingredient 2 2
Excess Flow or Over-Infusion 2 2
Difficult to Insert 2 2
Component Incompatible 2 2
Contamination 2 2
Bent 2 2
Backflow 2 2
Failure to Advance 2 2
Obstruction of Flow 2 2
Contamination of Device Ingredient or Reagent 2 2
Difficult to Remove 2 2
Tear, Rip or Hole in Device Packaging 2 2
Chemical Spillage 2 2
Manufacturing, Packaging or Shipping Problem 2 2
No Flow 2 2
Adverse Event Without Identified Device or Use Problem 2 2
No Pressure 2 2
Material Twisted/Bent 2 2
Therapeutic or Diagnostic Output Failure 2 2
Positioning Problem 2 2
Air/Gas in Device 2 2
Difficult or Delayed Separation 1 1
Inaccurate Information 1 1
Suction Failure 1 1
Device Fell 1 1
Pressure Problem 1 1
Unintended Movement 1 1
Material Split, Cut or Torn 1 1
Device Handling Problem 1 1
Mechanical Jam 1 1
Naturally Worn 1 1
Material Integrity Problem 1 1
Device Contaminated During Manufacture or Shipping 1 1
Gas Leak 1 1
Overfill 1 1
Inaccurate Delivery 1 1
Component Missing 1 1
Incorrect, Inadequate or Imprecise Resultor Readings 1 1
Unstable 1 1
Improper or Incorrect Procedure or Method 1 1
Insufficient Flow or Under Infusion 1 1
Device Disinfection Or Sterilization Issue 1 1
Device-Device Incompatibility 1 1
Difficult to Open or Close 1 1
Device Dislodged or Dislocated 1 1
Fail-Safe Problem 1 1
Expiration Date Error 1 1
Device Displays Incorrect Message 1 1
Deformation Due to Compressive Stress 1 1
Loss of or Failure to Bond 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 590 590
No Clinical Signs, Symptoms or Conditions 493 493
No Consequences Or Impact To Patient 419 419
Chemical Exposure 181 181
No Patient Involvement 115 115
Insufficient Information 43 43
No Information 29 29
Needle Stick/Puncture 4 4
Underdose 4 4
Pain 4 4
Hemorrhage/Bleeding 3 3
Injury 3 3
No Code Available 3 3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 3 3
Blood Loss 3 3
Exposure to Body Fluids 2 2
Eye Injury 1 1
Fall 1 1
Distress 1 1
Chest Tightness/Pressure 1 1
Hemorrhage, Subarachnoid 1 1
High Blood Pressure/ Hypertension 1 1
Irritation 1 1
Rash 1 1
Skin Irritation 1 1
Swelling 1 1
Tachycardia 1 1
Tingling 1 1
Muscle/Tendon Damage 1 1
Unspecified Tissue Injury 1 1

Recalls
Manufacturer Recall Class Date Posted
1 ICU Medical, Inc. II May-13-2021
2 ICU Medical, Inc. II Dec-23-2020
3 ICU Medical, Inc. I Feb-22-2019
4 ICU Medical, Inc. II Oct-11-2018
5 J&J Solutions, Inc. DBA Corvida Medical II Jan-11-2017
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