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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 1
CAREFUSION
  SUBSTANTIALLY EQUIVALENT 2
EPIC MEDICAL PTE LTD
  SUBSTANTIALLY EQUIVALENT 1
EPIC MEDICAL PTE. LTD.
  SUBSTANTIALLY EQUIVALENT 9
EQUASHIELD MEDICAL LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHINVA ANDE HEALTHCARE APPARATUS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SIMPLIVIA HEALTHCARE LTD.
  SUBSTANTIALLY EQUIVALENT 4
YUKON MEDICAL, LLC
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2020 441 441
2021 548 548
2022 448 450
2023 456 456
2024 686 686
2025 43 43

Device Problems MDRs with this Device Problem Events in those MDRs
Leak/Splash 845 845
Fluid/Blood Leak 601 600
Device Contamination with Chemical or Other Material 289 289
Disconnection 171 171
Break 151 151
Material Separation 104 104
Loose or Intermittent Connection 57 56
Detachment of Device or Device Component 57 60
Contamination 46 46
Infusion or Flow Problem 44 44
Particulates 41 41
Air/Gas in Device 39 39
Difficult or Delayed Activation 36 36
Defective Component 36 36
No Flow 33 33
Complete Blockage 29 29
Crack 28 28
Separation Problem 21 21
Failure to Infuse 18 18
Contamination /Decontamination Problem 11 11
Improper Flow or Infusion 11 11
Retraction Problem 10 10
Obstruction of Flow 10 10
Incomplete or Inadequate Connection 8 8
Device Markings/Labelling Problem 8 8
Defective Device 8 8
Packaging Problem 8 8
Material Twisted/Bent 7 7
Connection Problem 7 7
Component Missing 6 6
Insufficient Flow or Under Infusion 6 6
Mechanical Problem 6 6
Excess Flow or Over-Infusion 5 5
Restricted Flow rate 5 5
Material Puncture/Hole 5 5
Decoupling 4 4
Backflow 4 4
Material Protrusion/Extrusion 4 4
Inaccurate Delivery 4 4
Protective Measures Problem 4 4
Fail-Safe Problem 3 3
Product Quality Problem 3 3
Material Split, Cut or Torn 3 3
Unsealed Device Packaging 3 3
Premature Separation 3 3
Material Deformation 3 3
Device Difficult to Setup or Prepare 3 3
Burst Container or Vessel 3 3
Volume Accuracy Problem 3 3
Failure to Deliver 3 3

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 1951 1953
No Consequences Or Impact To Patient 248 248
Chemical Exposure 230 230
Insufficient Information 138 138
No Known Impact Or Consequence To Patient 117 117
No Patient Involvement 79 79
Hemorrhage/Bleeding 8 8
Blood Loss 3 3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 3 3
No Information 3 3
Underdose 2 2
Swelling 1 1
Eye Injury 1 1
Unspecified Tissue Injury 1 1
Muscle/Tendon Damage 1 1
Needle Stick/Puncture 1 1
Skin Irritation 1 1
Extravasation 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 Dec-09-2024
4 ICU Medical, Inc. II Sep-07-2022
5 ICU Medical, Inc. II May-13-2021
6 ICU Medical, Inc. II Dec-23-2020
7 SIMPLIVIA HEALTHCARE LTD. II May-11-2022
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