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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 & CO.
  SUBSTANTIALLY EQUIVALENT 2
BECTON, DICKINSON AND COMPANY
  SUBSTANTIALLY EQUIVALENT 3
CAREFUSION
  SUBSTANTIALLY EQUIVALENT 2
EPIC MEDICAL PTE LTD
  SUBSTANTIALLY EQUIVALENT 1
EPIC MEDICAL PTE. LTD.
  SUBSTANTIALLY EQUIVALENT 2
EQUASHIELD MEDICAL LTD
  SUBSTANTIALLY EQUIVALENT 2
EQUASHIELD MEDICAL LTD.
  SUBSTANTIALLY EQUIVALENT 2
ICU MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
ICU MEDICAL INC
  SUBSTANTIALLY EQUIVALENT 2
ICU MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
J & J SOLUTIONS, INC. D/B/A/ CORVIDA MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
J & J SOLUTIONS, INC. D/B/A/CORVIDA MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
JMS NORTH AMERICA CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
SHINVA ANDE HEALTHCARE APPARATUS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SIMPLIVIA HEALTHCARE LTD.
  SUBSTANTIALLY EQUIVALENT 4
TEVA MEDICAL LTD., MIGADA PLANT
  SUBSTANTIALLY EQUIVALENT 3
YUKON MEDICAL, LLC
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2014 3 3
2015 4 4
2016 13 13
2017 66 66
2018 228 228
2019 461 461
2020 441 441
2021 548 548
2022 448 450
2023 456 456
2024 200 200

Device Problems MDRs with this Device Problem Events in those MDRs
Leak/Splash 1051 1051
Fluid/Blood Leak 639 638
Device Contamination with Chemical or Other Material 326 326
Break 159 159
Disconnection 114 114
Material Separation 84 84
Infusion or Flow Problem 79 79
Detachment of Device or Device Component 67 70
Loose or Intermittent Connection 54 53
Difficult or Delayed Activation 51 51
Contamination 38 38
Particulates 33 33
Crack 32 32
Air/Gas in Device 23 23
Defective Component 21 21
Contamination /Decontamination Problem 20 20
Complete Blockage 19 19
Failure to Infuse 17 17
Separation Problem 17 17
Connection Problem 16 16
Retraction Problem 13 13
Improper Flow or Infusion 12 12
Material Protrusion/Extrusion 10 10
No Flow 9 9
Defective Device 9 9
Incomplete or Inadequate Connection 9 9
Packaging Problem 9 9
Device Operates Differently Than Expected 8 8
Material Twisted/Bent 8 8
Use of Device Problem 8 8
Obstruction of Flow 7 7
Protective Measures Problem 7 7
Physical Resistance/Sticking 6 6
Material Deformation 6 6
Chemical Spillage 6 6
Insufficient Flow or Under Infusion 6 6
Component Missing 6 6
Mechanical Problem 6 6
Misconnection 6 6
Occlusion Within Device 5 5
Inflation Problem 5 5
Detachment Of Device Component 5 5
Material Puncture/Hole 5 5
Product Quality Problem 5 5
Device Markings/Labelling Problem 5 5
Appropriate Term/Code Not Available 5 5
Fail-Safe Problem 4 4
Device Damaged Prior to Use 4 4
Contamination of Device Ingredient or Reagent 4 4
Free or Unrestricted Flow 4 4
Material Fragmentation 4 4
Device Difficult to Setup or Prepare 4 4
Device Slipped 4 4
Failure to Deliver 4 4
Inaccurate Delivery 4 4
Fitting Problem 4 4
Structural Problem 4 4
Backflow 4 4
Decoupling 4 4
Deflation Problem 4 4
Excess Flow or Over-Infusion 4 4
Unintended Ejection 4 4
Restricted Flow rate 4 4
Unsealed Device Packaging 3 3
Moisture Damage 3 3
Delivered as Unsterile Product 3 3
Burst Container or Vessel 3 3
Volume Accuracy Problem 3 3
Gas/Air Leak 3 3
Activation Failure 3 3
Premature Separation 3 3
Material Split, Cut or Torn 2 2
Therapeutic or Diagnostic Output Failure 2 2
Positioning Problem 2 2
Manufacturing, Packaging or Shipping Problem 2 2
Compatibility Problem 2 2
Mechanical Jam 2 2
Adverse Event Without Identified Device or Use Problem 2 2
No Pressure 2 2
Improper or Incorrect Procedure or Method 2 2
Failure to Advance 2 2
Tear, Rip or Hole in Device Packaging 2 2
Shielding Failure 2 2
Difficult to Remove 2 2
Precipitate in Device or Device Ingredient 2 2
Component Incompatible 2 2
Bent 2 2
Loss of or Failure to Bond 2 2
Fracture 2 2
Difficult to Insert 2 2
Inability to Irrigate 1 1
Radiation Leak 1 1
Partial Blockage 1 1
Degraded 1 1
Fail-Safe Design Failure 1 1
Decrease in Suction 1 1
Premature Activation 1 1
Peeled/Delaminated 1 1
Incorrect, Inadequate or Imprecise Result or Readings 1 1
Short Fill 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 1474 1476
No Known Impact Or Consequence To Patient 595 595
No Consequences Or Impact To Patient 427 427
Chemical Exposure 292 292
No Patient Involvement 115 115
Insufficient Information 112 112
No Information 33 33
Needle Stick/Puncture 5 5
Hemorrhage/Bleeding 5 5
Pain 4 4
Underdose 4 4
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
Rash 1 1
Skin Irritation 1 1
Swelling 1 1
Tachycardia 1 1
Tingling 1 1
Hemorrhage, Subarachnoid 1 1
High Blood Pressure/ Hypertension 1 1
Irritation 1 1
Muscle/Tendon Damage 1 1
Unspecified Tissue Injury 1 1

Recalls
Manufacturer Recall Class Date Posted
1 B. Braun Medical, Inc. II Nov-03-2023
2 Becton Dickinson & Company II Aug-18-2022
3 ICU Medical, Inc. II Sep-07-2022
4 ICU Medical, Inc. II May-13-2021
5 ICU Medical, Inc. II Dec-23-2020
6 ICU Medical, Inc. I Feb-22-2019
7 ICU Medical, Inc. II Oct-11-2018
8 J&J Solutions, Inc. DBA Corvida Medical II Jan-11-2017
9 SIMPLIVIA HEALTHCARE LTD. II May-11-2022
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