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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device device, urine flow rate measuring, non-electrical, disposable
Regulation Description Urine flow or volume measuring system.
Product CodeFFG
Regulation Number 876.1800
Device Class 2

MDR Year MDR Reports MDR Events
2021 109 110
2022 21 21
2023 6 6
2024 3 3
2025 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
Detachment of Device or Device Component 98 98
Obstruction of Flow 17 17
Infusion or Flow Problem 6 6
Break 4 4
Material Integrity Problem 4 4
Contamination /Decontamination Problem 3 3
No Flow 3 3
Disconnection 2 2
Leak/Splash 1 1
Crack 1 1
Unintended Deflation 1 1
Material Fragmentation 1 1
Inflation Problem 1 1
Material Separation 1 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 124 125
Insufficient Information 17 17
Urinary Retention 3 3
Obstruction/Occlusion 2 2
Foreign Body In Patient 2 2
Pain 2 2
Unspecified Mental, Emotional or Behavioural Problem 1 1
Burning Sensation 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Cardinal Health 200, LLC I Feb-16-2024
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