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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
Product CodeFFG
Regulation Number 876.1800
Device Class 2

MDR Year MDR Reports MDR Events
2019 9 9
2020 92 92
2021 109 109
2022 21 21
2023 6 6
2024 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Detachment of Device or Device Component 178 178
Obstruction of Flow 19 19
No Flow 15 15
Infusion or Flow Problem 6 6
Material Integrity Problem 5 5
Material Separation 4 4
Device Contamination with Chemical or Other Material 3 3
Break 3 3
Disconnection 3 3
Contamination /Decontamination Problem 3 3
Connection Problem 1 1
Unintended Deflation 1 1
Crack 1 1
Material Fragmentation 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 131 131
No Consequences Or Impact To Patient 65 65
Insufficient Information 16 16
Urinary Retention 13 13
No Known Impact Or Consequence To Patient 6 6
No Information 4 4
Pain 4 4
No Patient Involvement 4 4
Foreign Body In Patient 4 4
Discomfort 2 2
Obstruction/Occlusion 2 2
Abdominal Distention 2 2
Urinary Tract Infection 1 1
Burning Sensation 1 1
Unspecified Mental, Emotional or Behavioural Problem 1 1

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