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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
Product CodeKYW
Regulation Number 880.6430
Device Class 1

MDR Year MDR Reports MDR Events
2019 38 38
2020 24 24
2021 15 15
2022 35 35
2023 19 19
2024 5 5

Device Problems MDRs with this Device Problem Events in those MDRs
Device Contamination with Chemical or Other Material 36 36
Device Markings/Labelling Problem 22 22
Fluid/Blood Leak 10 10
Leak/Splash 10 10
Volume Accuracy Problem 9 9
Patient Device Interaction Problem 9 9
Physical Resistance/Sticking 5 5
Break 4 4
Defective Component 3 3
Illegible Information 3 3
Adverse Event Without Identified Device or Use Problem 2 2
Packaging Problem 2 2
Manufacturing, Packaging or Shipping Problem 2 2
Failure to Deliver 2 2
Delivered as Unsterile Product 2 2
Product Quality Problem 1 1
Shipping Damage or Problem 1 1
Loose or Intermittent Connection 1 1
Complete Blockage 1 1
Crack 1 1
Disconnection 1 1
Material Disintegration 1 1
Obstruction of Flow 1 1
Expiration Date Error 1 1
Patient-Device Incompatibility 1 1
Contamination of Device Ingredient or Reagent 1 1
Fungus in Device Environment 1 1
Human-Device Interface Problem 1 1
Material Deformation 1 1
Material Integrity Problem 1 1
Mechanical Jam 1 1
Sharp Edges 1 1
Missing Information 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 63 63
No Known Impact Or Consequence To Patient 38 38
No Patient Involvement 13 13
No Consequences Or Impact To Patient 6 6
Pulmonary Emphysema 5 5
Pneumonia 2 2
Insufficient Information 2 2
No Information 2 2
No Code Available 1 1
Reaction to Medicinal Component of Device 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Foreign Body In Patient 1 1
Pneumothorax 1 1
Choking 1 1
Underdose 1 1
Overdose 1 1
Airway Obstruction 1 1
Aspiration/Inhalation 1 1
Dyspnea 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
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