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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
2015 1 1
2016 1 1
2017 3 3
2018 23 23
2019 38 38
2020 24 24
2021 15 15
2022 35 35
2023 19 19
2024 10 10

Device Problems MDRs with this Device Problem Events in those MDRs
Device Contamination with Chemical or Other Material 40 40
Device Markings/Labelling Problem 31 31
Fluid/Blood Leak 11 11
Leak/Splash 10 10
Volume Accuracy Problem 10 10
Patient Device Interaction Problem 9 9
Break 6 6
Physical Resistance/Sticking 5 5
Defective Component 3 3
Manufacturing, Packaging or Shipping Problem 3 3
Packaging Problem 3 3
Illegible Information 3 3
Contamination /Decontamination Problem 3 3
Loose or Intermittent Connection 3 3
Device Packaging Compromised 2 2
Failure to Deliver 2 2
Adverse Event Without Identified Device or Use Problem 2 2
Delivered as Unsterile Product 2 2
Material Deformation 2 2
Appropriate Term/Code Not Available 2 2
Component Missing 1 1
Obstruction of Flow 1 1
Material Discolored 1 1
Contamination 1 1
Moisture Damage 1 1
Incorrect, Inadequate or Imprecise Result or Readings 1 1
Disconnection 1 1
Mechanical Jam 1 1
Complete Blockage 1 1
Patient-Device Incompatibility 1 1
Material Disintegration 1 1
Split 1 1
Crack 1 1
Device Damaged Prior to Use 1 1
Fungus in Device Environment 1 1
Human-Device Interface Problem 1 1
Missing Information 1 1
Sticking 1 1
Product Quality Problem 1 1
Contamination of Device Ingredient or Reagent 1 1
Device Disinfection Or Sterilization Issue 1 1
Sharp Edges 1 1
Shipping Damage or Problem 1 1
Unsealed Device Packaging 1 1
Expiration Date Error 1 1
Material Integrity Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 67 67
No Known Impact Or Consequence To Patient 60 60
No Patient Involvement 15 15
No Consequences Or Impact To Patient 9 9
Pulmonary Emphysema 5 5
No Information 3 3
Insufficient Information 3 3
Pneumonia 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Pneumothorax 1 1
No Code Available 1 1
Aspiration/Inhalation 1 1
Reaction to Medicinal Component of Device 1 1
Overdose 1 1
Foreign Body In Patient 1 1
Dyspnea 1 1
Choking 1 1
Underdose 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 Medline Industries Inc II Aug-11-2016
4 Sol-Millennium Medical Inc. II Sep-06-2024
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