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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
2020 92 101
2021 109 110
2022 21 21
2023 6 6
2024 3 3
2025 4 4

Device Problems MDRs with this Device Problem Events in those MDRs
Detachment of Device or Device Component 178 178
Obstruction of Flow 17 17
No Flow 7 7
Material Integrity Problem 6 15
Infusion or Flow Problem 6 6
Break 4 4
Material Separation 4 14
Disconnection 3 3
Contamination /Decontamination Problem 3 3
Device Contamination with Chemical or Other Material 3 3
Leak/Splash 1 1
Crack 1 1
Unintended Deflation 1 1
Material Fragmentation 1 1
Inflation Problem 1 1
Connection Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 134 135
No Consequences Or Impact To Patient 63 63
Insufficient Information 17 17
Urinary Retention 7 7
No Known Impact Or Consequence To Patient 6 15
No Information 4 4
No Patient Involvement 4 4
Pain 4 4
Foreign Body In Patient 3 3
Abdominal Distention 2 2
Obstruction/Occlusion 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Unspecified Mental, Emotional or Behavioural Problem 1 1
Burning Sensation 1 1
Urinary Tract Infection 1 1

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