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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device dispenser, liquid medication
Product CodeKYX
Regulation Number 880.6430
Device Class 1

MDR Year MDR Reports MDR Events
2018 17 17
2019 17 27
2020 33 33
2021 7 7
2022 11 11
2023 28 28

Device Problems MDRs with this Device Problem Events in those MDRs
Device Contamination with Chemical or Other Material 20 30
Device Markings/Labelling Problem 18 18
Contamination /Decontamination Problem 11 11
Leak/Splash 10 10
Unsealed Device Packaging 10 10
Fluid/Blood Leak 8 8
Break 7 7
Illegible Information 4 4
Component Missing 3 3
Device Contaminated During Manufacture or Shipping 3 3
Adverse Event Without Identified Device or Use Problem 3 3
Failure to Deliver 2 2
Product Quality Problem 2 2
Device Damaged Prior to Use 2 2
Malposition of Device 2 2
Application Program Problem: Medication Error 2 2
Device Fell 1 1
Missing Information 1 1
Device Contaminated at the User Facility 1 1
Use of Device Problem 1 1
Volume Accuracy Problem 1 1
Improper or Incorrect Procedure or Method 1 1
Fitting Problem 1 1
Fungus in Device Environment 1 1
Particulates 1 1
Complete Blockage 1 1
Contamination 1 1
Material Discolored 1 1
Difficult to Fold, Unfold or Collapse 1 1
Mechanical Problem 1 1
Inaccurate Delivery 1 1
Obstruction of Flow 1 1
Defective Device 1 1
Connection Problem 1 1
Contamination of Device Ingredient or Reagent 1 1
Detachment of Device or Device Component 1 1
Positioning Problem 1 1
Protective Measures Problem 1 1
Scratched Material 1 1
Manufacturing, Packaging or Shipping Problem 1 1
No Fail-Safe Mechanism 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 32 32
No Known Impact Or Consequence To Patient 31 31
No Patient Involvement 23 33
Insufficient Information 11 11
No Consequences Or Impact To Patient 11 11
Eye Infections 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Aspiration/Inhalation 1 1
No Information 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Baxter Healthcare Corporation II Apr-20-2023
2 Baxter Healthcare Corporation II Aug-25-2022
3 Baxter Healthcare Corporation II Apr-15-2022
4 Baxter Healthcare Corporation III Aug-29-2019
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