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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 Markings/Labelling Problem 16 16
Device Contamination with Chemical or Other Material 16 26
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
Device Contaminated During Manufacture or Shipping 3 3
Component Missing 3 3
Product Quality Problem 2 2
Contamination 2 2
Malposition of Device 2 2
Failure to Deliver 2 2
Device Damaged Prior to Use 2 2
Application Program Problem: Medication Error 2 2
Missing Information 1 1
Device Contaminated at the User Facility 1 1
Inaccurate Delivery 1 1
Obstruction of Flow 1 1
Defective Device 1 1
Patient-Device Incompatibility 1 1
Connection Problem 1 1
Contamination of Device Ingredient or Reagent 1 1
No Fail-Safe Mechanism 1 1
Protective Measures Problem 1 1
Scratched Material 1 1
Appropriate Term/Code Not Available 1 1
Crack 1 1
Material Discolored 1 1
Complete Blockage 1 1
Difficult to Fold, Unfold or Collapse 1 1
Mechanical Problem 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

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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