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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 5 5

Device Problems MDRs with this Device Problem Events in those MDRs
Device Contamination with Chemical or Other Material 39 39
Device Markings/Labelling Problem 29 29
Fluid/Blood Leak 11 11
Leak/Splash 10 10
Patient Device Interaction Problem 9 9
Volume Accuracy Problem 9 9
Break 6 6
Physical Resistance/Sticking 5 5
Packaging Problem 3 3
Loose or Intermittent Connection 3 3
Manufacturing, Packaging or Shipping Problem 3 3
Defective Component 3 3
Illegible Information 3 3
Contamination /Decontamination Problem 3 3
Delivered as Unsterile Product 2 2
Adverse Event Without Identified Device or Use Problem 2 2
Failure to Deliver 2 2
Appropriate Term/Code Not Available 2 2
Material Deformation 2 2
Device Packaging Compromised 2 2
Complete Blockage 1 1
Mechanical Jam 1 1
Unsealed Device Packaging 1 1
Sticking 1 1
Contamination of Device Ingredient or Reagent 1 1
Device Disinfection Or Sterilization Issue 1 1
Moisture Damage 1 1
Device Damaged Prior to Use 1 1
Sharp Edges 1 1
Disconnection 1 1
Fungus in Device Environment 1 1
Split 1 1
Incorrect, Inadequate or Imprecise Result or Readings 1 1
Crack 1 1
Obstruction of Flow 1 1
Shipping Damage or Problem 1 1
Component Missing 1 1
Patient-Device Incompatibility 1 1
Expiration Date Error 1 1
Material Disintegration 1 1
Human-Device Interface Problem 1 1
Material Discolored 1 1
Missing Information 1 1
Product Quality Problem 1 1
Material Integrity Problem 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 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 2 2
Pneumonia 2 2
Pneumothorax 1 1
Choking 1 1
Underdose 1 1
Overdose 1 1
Airway Obstruction 1 1
Aspiration/Inhalation 1 1
Dyspnea 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Foreign Body In Patient 1 1
No Code Available 1 1
Reaction to Medicinal Component of Device 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
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