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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device collector, urine, pediatric, for indwelling catheter
Regulation Description Urine collector and accessories.
Product CodeFFH
Regulation Number 876.5250
Device Class 2

MDR Year MDR Reports MDR Events
2020 2 2
2021 1 1
2022 5 5
2023 12 12
2024 5 5
2025 12 12

Device Problems MDRs with this Device Problem Events in those MDRs
Disconnection 8 8
Material Fragmentation 7 7
Fitting Problem 4 4
Defective Component 3 3
Material Twisted/Bent 3 3
Difficult to Remove 2 2
Use of Device Problem 2 2
Component Missing 2 2
Component Misassembled 2 2
Fluid/Blood Leak 2 2
Difficult to Open or Remove Packaging Material 1 1
Defective Device 1 1
Inaccurate Flow Rate 1 1
Detachment of Device or Device Component 1 1
Device Contamination with Chemical or Other Material 1 1
Gel Leak 1 1
Loose or Intermittent Connection 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 29 29
Foreign Body In Patient 3 3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
Insufficient Information 2 2
Exposure to Body Fluids 2 2
No Known Impact Or Consequence To Patient 1 1
No Patient Involvement 1 1

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