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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
2018 23 23
2019 38 38
2020 24 24
2021 15 15
2022 35 35
2023 8 8

Device Problems MDRs with this Device Problem Events in those MDRs
Device Contamination with Chemical or Other Material 36 36
Device Markings/Labelling Problem 26 26
Fluid/Blood Leak 10 10
Leak/Splash 10 10
Patient Device Interaction Problem 9 9
Volume Accuracy Problem 8 8
Break 6 6
Physical Resistance/Sticking 4 4
Illegible Information 3 3
Contamination /Decontamination Problem 3 3
Device Packaging Compromised 2 2
Failure to Deliver 2 2
Adverse Event Without Identified Device or Use Problem 2 2
Packaging Problem 2 2
Appropriate Term/Code Not Available 2 2
Manufacturing, Packaging or Shipping Problem 2 2
Material Deformation 2 2
Loose or Intermittent Connection 2 2
Delivered as Unsterile Product 2 2
Unsealed Device Packaging 1 1
Product Quality Problem 1 1
Incorrect, Inadequate or Imprecise Result or Readings 1 1
Shipping Damage or Problem 1 1
Device Damaged Prior to Use 1 1
Defective Component 1 1
Component Missing 1 1
Fungus in Device Environment 1 1
Moisture Damage 1 1
Complete Blockage 1 1
Crack 1 1
Material Discolored 1 1
Material Disintegration 1 1
Material Integrity Problem 1 1
Mechanical Jam 1 1
Human-Device Interface Problem 1 1
Obstruction of Flow 1 1
Split 1 1
Patient-Device Incompatibility 1 1
Contamination of Device Ingredient or Reagent 1 1
Device Disinfection Or Sterilization Issue 1 1
Sharp Edges 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 57 57
No Clinical Signs, Symptoms or Conditions 47 47
No Patient Involvement 14 14
No Consequences Or Impact To Patient 8 8
Pulmonary Emphysema 5 5
No Information 3 3
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
No Code Available 1 1
Reaction to Medicinal Component of Device 1 1
Insufficient Information 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Foreign Body In Patient 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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