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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 1
CAREFUSION
  SUBSTANTIALLY EQUIVALENT 2
EPIC MEDICAL PTE LTD
  SUBSTANTIALLY EQUIVALENT 1
EPIC MEDICAL PTE. LTD.
  SUBSTANTIALLY EQUIVALENT 3
EQUASHIELD MEDICAL LTD.
  SUBSTANTIALLY EQUIVALENT 1
ICU MEDICAL
  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
2019 461 461
2020 441 441
2021 548 548
2022 448 450
2023 456 456
2024 277 277

Device Problems MDRs with this Device Problem Events in those MDRs
Leak/Splash 984 984
Fluid/Blood Leak 564 563
Device Contamination with Chemical or Other Material 303 303
Break 139 139
Disconnection 120 120
Material Separation 83 83
Infusion or Flow Problem 81 81
Detachment of Device or Device Component 61 64
Difficult or Delayed Activation 51 51
Loose or Intermittent Connection 51 50
Contamination 38 38
Air/Gas in Device 33 33
Particulates 32 32
Crack 25 25
Defective Component 23 23
Complete Blockage 20 20
Failure to Infuse 17 17
Separation Problem 17 17
No Flow 17 17
Contamination /Decontamination Problem 13 13
Retraction Problem 12 12
Improper Flow or Infusion 11 11
Packaging Problem 9 9
Incomplete or Inadequate Connection 9 9
Connection Problem 8 8
Defective Device 8 8
Obstruction of Flow 7 7
Material Twisted/Bent 7 7
Material Protrusion/Extrusion 6 6
Protective Measures Problem 6 6
Device Markings/Labelling Problem 6 6
Mechanical Problem 6 6
Insufficient Flow or Under Infusion 5 5
Product Quality Problem 5 5
Component Missing 5 5
Physical Resistance/Sticking 5 5
Free or Unrestricted Flow 4 4
Material Deformation 4 4
Failure to Deliver 4 4
Inaccurate Delivery 4 4
Device Difficult to Setup or Prepare 4 4
Material Puncture/Hole 4 4
Excess Flow or Over-Infusion 4 4
Restricted Flow rate 4 4
Decoupling 4 4
Backflow 4 4
Burst Container or Vessel 3 3
Deflation Problem 3 3
Delivered as Unsterile Product 3 3
Unsealed Device Packaging 3 3
Use of Device Problem 3 3
Volume Accuracy Problem 3 3
Structural Problem 3 3
Contamination of Device Ingredient or Reagent 3 3
Fail-Safe Problem 3 3
Activation Failure 3 3
Premature Separation 3 3
Material Split, Cut or Torn 2 2
Therapeutic or Diagnostic Output Failure 2 2
Manufacturing, Packaging or Shipping Problem 2 2
Gas/Air Leak 2 2
Compatibility Problem 2 2
Mechanical Jam 2 2
Adverse Event Without Identified Device or Use Problem 2 2
No Pressure 2 2
Device Damaged Prior to Use 2 2
Device Slipped 2 2
Shielding Failure 2 2
Tear, Rip or Hole in Device Packaging 2 2
Fracture 2 2
Material Fragmentation 2 2
Inflation Problem 2 2
Loss of or Failure to Bond 2 2
Unintended Ejection 2 2
Degraded 1 1
Component Incompatible 1 1
Partial Blockage 1 1
Decrease in Suction 1 1
Misconnection 1 1
Difficult to Insert 1 1
Inability to Irrigate 1 1
Precipitate in Device or Device Ingredient 1 1
Premature Activation 1 1
Overfill 1 1
Dull, Blunt 1 1
Short Fill 1 1
Material Rupture 1 1
Self-Activation or Keying 1 1
Device Dislodged or Dislocated 1 1
Environmental Compatibility Problem 1 1
Expiration Date Error 1 1
Fitting Problem 1 1
Material Perforation 1 1
Device Displays Incorrect Message 1 1
Deformation Due to Compressive Stress 1 1
Output Problem 1 1
Naturally Worn 1 1
Pressure Problem 1 1
Material Integrity Problem 1 1
Unintended Movement 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 1547 1549
No Known Impact Or Consequence To Patient 432 432
No Consequences Or Impact To Patient 311 311
Chemical Exposure 239 239
Insufficient Information 115 115
No Patient Involvement 110 110
No Information 21 21
Needle Stick/Puncture 5 5
Hemorrhage/Bleeding 5 5
Pain 4 4
Underdose 4 4
Blood Loss 3 3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 3 3
No Code Available 2 2
Exposure to Body Fluids 2 2
Eye Injury 1 1
Fall 1 1
Hemorrhage, Subarachnoid 1 1
High Blood Pressure/ Hypertension 1 1
Rash 1 1
Skin Irritation 1 1
Swelling 1 1
Tachycardia 1 1
Chest Tightness/Pressure 1 1
Injury 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 SIMPLIVIA HEALTHCARE LTD. II May-11-2022
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