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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
Product CodeFFH
Regulation Number 876.5250
Device Class 2

MDR Year MDR Reports MDR Events
2019 4 4
2020 2 2
2021 1 1
2022 5 5
2023 12 12

Device Problems MDRs with this Device Problem Events in those MDRs
Disconnection 4 4
Component Missing 4 4
Fitting Problem 3 3
Material Fragmentation 3 3
Component Misassembled 2 2
Difficult to Remove 2 2
Material Twisted/Bent 1 1
Inaccurate Flow Rate 1 1
Device Contamination with Chemical or Other Material 1 1
Short Fill 1 1
Device Damaged Prior to Use 1 1
Loose or Intermittent Connection 1 1
Moisture or Humidity Problem 1 1
Defective Device 1 1
Fluid/Blood Leak 1 1
Difficult to Open or Remove Packaging Material 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 15 15
No Known Impact Or Consequence To Patient 4 4
No Patient Involvement 2 2
Foreign Body In Patient 2 2
Insufficient Information 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Patient Problem/Medical Problem 1 1
No Consequences Or Impact To Patient 1 1

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