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U.S. Department of Health and Human Services

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

MDR Year MDR Reports MDR Events
2020 112 112
2021 173 173
2022 12 12
2023 3 3
2024 6 6

Device Problems MDRs with this Device Problem Events in those MDRs
Detachment of Device or Device Component 109 109
Misconnection 68 68
Loss of or Failure to Bond 35 35
Adverse Event Without Identified Device or Use Problem 17 17
Disconnection 16 16
Difficult to Open or Close 16 16
Material Twisted/Bent 15 15
Break 9 9
Malposition of Device 8 8
Loose or Intermittent Connection 7 7
Contamination /Decontamination Problem 7 7
Defective Component 6 6
Material Separation 4 4
Product Quality Problem 4 4
Mechanical Problem 3 3
Patient-Device Incompatibility 3 3
Difficult to Remove 3 3
Material Deformation 2 2
Degraded 2 2
Therapeutic or Diagnostic Output Failure 2 2
Defective Device 2 2
Inadequate Instructions for Healthcare Professional 1 1
Device Difficult to Setup or Prepare 1 1
Component Missing 1 1
Positioning Problem 1 1
Infusion or Flow Problem 1 1
Material Integrity Problem 1 1
Unsealed Device Packaging 1 1
Incorrect Measurement 1 1
Device Fell 1 1
Physical Resistance/Sticking 1 1
Contamination of Device Ingredient or Reagent 1 1
Device Tipped Over 1 1
Device Contamination with Chemical or Other Material 1 1
Activation Failure 1 1
Appropriate Term/Code Not Available 1 1
Connection Problem 1 1
Fire 1 1
Material Split, Cut or Torn 1 1
Improper or Incorrect Procedure or Method 1 1
Material Frayed 1 1
Fluid/Blood Leak 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 162 162
No Consequences Or Impact To Patient 118 118
Ulcer 9 9
No Patient Involvement 8 8
Insufficient Information 6 6
Erythema 4 4
Foreign Body Reaction 3 3
Unspecified Infection 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Death 1 1
Skin Inflammation/ Irritation 1 1
Inflammation 1 1
Purulent Discharge 1 1
Itching Sensation 1 1
Blister 1 1
Foreign Body In Patient 1 1
Reaction 1 1
Contact Dermatitis 1 1
Skin Tears 1 1

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