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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device stand, infusion
Product CodeFOX
Regulation Number 880.6990
Device Class 1

MDR Year MDR Reports MDR Events
2019 23 23
2020 112 112
2021 173 173
2022 12 12
2023 3 3
2024 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Detachment of Device or Device Component 113 113
Misconnection 72 72
Loss of or Failure to Bond 37 37
Adverse Event Without Identified Device or Use Problem 17 17
Disconnection 16 16
Difficult to Open or Close 16 16
Material Twisted/Bent 16 16
Break 10 10
Loose or Intermittent Connection 8 8
Defective Component 8 8
Malposition of Device 8 8
Contamination /Decontamination Problem 8 8
Material Separation 5 5
Product Quality Problem 4 4
Difficult to Remove 4 4
Patient-Device Incompatibility 3 3
Mechanical Problem 3 3
Therapeutic or Diagnostic Output Failure 3 3
Material Deformation 2 2
Component Missing 2 2
Defective Device 2 2
Degraded 2 2
Incorrect Measurement 1 1
Fire 1 1
Fluid/Blood Leak 1 1
Material Frayed 1 1
Inadequate Instructions for Healthcare Professional 1 1
Shipping Damage or Problem 1 1
Improper or Incorrect Procedure or Method 1 1
Delivered as Unsterile Product 1 1
Unsealed Device Packaging 1 1
Device Difficult to Setup or Prepare 1 1
Device Tipped Over 1 1
Connection Problem 1 1
Contamination of Device Ingredient or Reagent 1 1
Material Integrity Problem 1 1
Device Contamination with Chemical or Other Material 1 1
Infusion or Flow Problem 1 1
Device Contaminated During Manufacture or Shipping 1 1
Insufficient Information 1 1
Appropriate Term/Code Not Available 1 1
Activation Failure 1 1
Material Split, Cut or Torn 1 1
Physical Resistance/Sticking 1 1
Device Fell 1 1
Positioning Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 159 159
No Consequences Or Impact To Patient 127 127
No Patient Involvement 10 10
No Known Impact Or Consequence To Patient 9 9
Ulcer 9 9
Insufficient Information 6 6
Erythema 4 4
Foreign Body Reaction 3 3
Skin Irritation 2 2
Inflammation 1 1
Itching Sensation 1 1
Complaint, Ill-Defined 1 1
Reaction 1 1
Skin Tears 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Blister 1 1
Skin Inflammation/ Irritation 1 1
Foreign Body In Patient 1 1
Death 1 1
Purulent Discharge 1 1

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