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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 13
2023 3 3
2024 6 6
2025 3 3
2026 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
Detachment of Device or Device Component 91 91
Misconnection 68 68
Loss of or Failure to Bond 30 30
Disconnection 16 16
Material Twisted/Bent 15 15
Adverse Event Without Identified Device or Use Problem 13 13
Defective Component 6 6
Break 5 5
Contamination /Decontamination Problem 5 5
Patient-Device Incompatibility 3 3
Material Deformation 2 2
Degraded 2 2
Difficult to Remove 2 2
Overheating of Device 1 1
Material Frayed 1 1
Unsealed Device Packaging 1 1
Improper or Incorrect Procedure or Method 1 1
Mechanical Problem 1 1
Appropriate Device Problem Term/Code Not Available 1 1
Material Integrity Problem 1 1
Device Difficult to Setup or Prepare 1 2
Contamination 1 1
Incorrect Measurement 1 2
Material Split, Cut or Torn 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 166 167
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
Skin Inflammation/ Irritation 1 1
Contact Dermatitis 1 1
Unspecified Infection 1 1
Inflammation 1 1
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available 1 1
Reaction 1 1
Purulent Discharge 1 1
Bone Fracture(s) 1 1
Skin Tears 1 1
Death 1 1
Blister 1 1
Foreign Body In Patient 1 1
Itching Sensation 1 1
Unspecified Tissue Injury 1 1

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