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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

Device Problems MDRs with this Device Problem Events in those MDRs
Disconnection 5 5
Material Fragmentation 5 5
Fitting Problem 3 3
Component Missing 2 2
Difficult to Remove 2 2
Component Misassembled 2 2
Material Twisted/Bent 2 2
Fluid/Blood Leak 1 1
Device Contamination with Chemical or Other Material 1 1
Loose or Intermittent Connection 1 1
Inaccurate Flow Rate 1 1
Difficult to Open or Remove Packaging Material 1 1
Defective Device 1 1
Gel Leak 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 20 20
Foreign Body In Patient 2 2
Insufficient Information 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
No Patient Involvement 1 1
No Known Impact Or Consequence To Patient 1 1

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