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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device container, liquid medication, graduated
Regulation Description Liquid medication dispenser.
Product CodeKYW
Regulation Number 880.6430
Device Class 1

MDR Year MDR Reports MDR Events
2020 24 24
2021 15 15
2022 35 35
2023 19 19
2024 13 13
2025 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Device Contamination with Chemical or Other Material 24 24
Device Markings/Labelling Problem 11 11
Leak/Splash 10 10
Patient Device Interaction Problem 9 9
Fluid/Blood Leak 9 9
Volume Accuracy Problem 8 8
Physical Resistance/Sticking 4 4
Defective Component 3 3
Failure to Deliver 2 2
Delivered as Unsterile Product 2 2
Packaging Problem 2 2
Disconnection 1 1
Break 1 1
Complete Blockage 1 1
Patient-Device Incompatibility 1 1
Expiration Date Error 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Contamination 1 1
Difficult to Remove 1 1
Contamination /Decontamination Problem 1 1
Shipping Damage or Problem 1 1
Obstruction of Flow 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Sharp Edges 1 1
Material Deformation 1 1
Labelling, Instructions for Use or Training Problem 1 1
Product Quality Problem 1 1
Illegible Information 1 1
Missing Information 1 1
Fungus in Device Environment 1 1
Loose or Intermittent Connection 1 1
Mechanical Jam 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 71 71
No Known Impact Or Consequence To Patient 10 10
No Patient Involvement 9 9
Pulmonary Emphysema 5 5
No Consequences Or Impact To Patient 5 5
Insufficient Information 3 3
Pneumonia 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Pneumothorax 1 1
Aspiration/Inhalation 1 1
Reaction to Medicinal Component of Device 1 1
Dyspnea 1 1
Airway Obstruction 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Centurion Medical Products Corporation II Feb-05-2020
2 Medicina Uk Ltd II Oct-20-2022
3 Sol-Millennium Medical Inc. II Sep-06-2024
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