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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
2019 17 27
2020 33 33
2021 7 7
2022 11 11
2023 31 31
2024 8 8

Device Problems MDRs with this Device Problem Events in those MDRs
Device Contamination with Chemical or Other Material 16 26
Device Markings/Labelling Problem 16 16
Contamination /Decontamination Problem 12 12
Leak/Splash 8 8
Unsealed Device Packaging 8 8
Break 6 6
Fluid/Blood Leak 5 5
Illegible Information 5 5
Adverse Event Without Identified Device or Use Problem 4 4
Component Missing 3 3
Device Contaminated During Manufacture or Shipping 3 3
Application Program Problem: Medication Error 2 2
Device Damaged Prior to Use 2 2
Malposition of Device 2 2
Failure to Deliver 2 2
Product Quality Problem 2 2
Contamination 2 2
Material Discolored 1 1
Improper or Incorrect Procedure or Method 1 1
Missing Information 1 1
Device Contaminated at the User Facility 1 1
Patient-Device Incompatibility 1 1
Appropriate Term/Code Not Available 1 1
Particulates 1 1
Obstruction of Flow 1 1
Use of Device Problem 1 1
Connection Problem 1 1
Volume Accuracy Problem 1 1
Fungus in Device Environment 1 1
Scratched Material 1 1
Mechanical Problem 1 1
Crack 1 1
No Fail-Safe Mechanism 1 1
Inaccurate Delivery 1 1
Defective Device 1 1
Protective Measures Problem 1 1
Complete Blockage 1 1
Difficult to Fold, Unfold or Collapse 1 1
Contamination of Device Ingredient or Reagent 1 1
Fitting Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 40 40
No Known Impact Or Consequence To Patient 24 24
No Patient Involvement 18 28
Insufficient Information 14 14
No Consequences Or Impact To Patient 8 8
Eye Infections 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 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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