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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
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
2022 281 306

Device Problems MDRs with this Device Problem Events in those MDRs
Leak/Splash 850 850
Fluid Leak 401 426
Device Contamination with Chemical or Other Material 264 264
Break 110 110
Infusion or Flow Problem 71 71
Disconnection 54 54
Detachment of Device or Device Component 53 53
Difficult or Delayed Activation 49 49
Material Separation 48 48
Crack 20 20
Loose or Intermittent Connection 18 43
Contamination /Decontamination Problem 15 15
Connection Problem 14 14
Separation Problem 9 9
Complete Blockage 9 9
Incomplete or Inadequate Connection 8 8
Air/Gas in Device 8 8
Material Protrusion/Extrusion 8 8
Device Operates Differently Than Expected 7 7
Particulates 7 7
Retraction Problem 7 7
Defective Component 7 7
Misconnection 6 6
Contamination 6 6
Packaging Problem 6 6
Physical Resistance/Sticking 6 6
Appropriate Term/Code Not Available 5 5
Material Twisted/Bent 5 5
Material Deformation 5 5
Decoupling 5 5
Occlusion Within Device 5 5
Inflation Problem 5 5
Use of Device Problem 5 5
Device Slipped 4 4
Fitting Problem 4 4
Device Damaged Prior to Use 4 4
Product Quality Problem 4 4
Obstruction of Flow 4 4
Structural Problem 4 4
Deflation Problem 4 4
Mechanical Problem 4 4
Detachment Of Device Component 4 4
Protective Measures Problem 4 4
Improper Flow or Infusion 4 4
Device Markings/Labelling Problem 4 4
Free or Unrestricted Flow 3 3
Activation Failure 3 3
Unintended Ejection 3 3
Moisture Damage 3 3
Excess Flow or Over-Infusion 3 3
Material Fragmentation 3 3
Defective Device 3 3
Failure to Deliver 3 3
Volume Accuracy Problem 3 3
Difficult to Remove 2 2
Precipitate in Device or Device Ingredient 2 2
Device Difficult to Setup or Prepare 2 2
Material Puncture/Hole 2 2
Failure to Advance 2 2
Chemical Spillage 2 2
Failure to Infuse 2 2
Tear, Rip or Hole in Device Packaging 2 2
Difficult to Insert 2 2
Delivered as Unsterile Product 2 2
Unsealed Device Packaging 2 2
Restricted Flow rate 2 2
Component Incompatible 2 2
Burst Container or Vessel 2 2
Bent 2 2
Backflow 2 2
Material Split, Cut or Torn 2 2
Therapeutic or Diagnostic Output Failure 2 2
Positioning Problem 2 2
No Flow 2 2
Adverse Event Without Identified Device or Use Problem 2 2
No Pressure 2 2
Gas Leak 2 2
Fail-Safe Problem 2 2
Manufacturing, Packaging or Shipping Problem 2 2
Contamination of Device Ingredient or Reagent 2 2
Premature Separation 2 2
Inaccurate Information 1 1
Difficult or Delayed Separation 1 1
Device Fell 1 1
Suction Failure 1 1
Activation Problem 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
Environmental Compatibility Problem 1 1
Device Contaminated During Manufacture or Shipping 1 1
Material Integrity Problem 1 1
Mechanical Jam 1 1
Naturally Worn 1 1
Pressure Problem 1 1
Unintended Movement 1 1
Device Handling Problem 1 1
Partial Blockage 1 1
Loss of or Failure to Bond 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 751 776
No Known Impact Or Consequence To Patient 590 590
No Consequences Or Impact To Patient 419 419
Chemical Exposure 206 206
No Patient Involvement 115 115
Insufficient Information 60 60
No Information 29 29
Needle Stick/Puncture 5 5
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 Becton Dickinson & Company II Aug-18-2022
2 ICU Medical, Inc. II Sep-07-2022
3 ICU Medical, Inc. II May-13-2021
4 ICU Medical, Inc. II Dec-23-2020
5 ICU Medical, Inc. I Feb-22-2019
6 ICU Medical, Inc. II Oct-11-2018
7 J&J Solutions, Inc. DBA Corvida Medical II Jan-11-2017
8 SIMPLIVIA HEALTHCARE LTD. II May-11-2022
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