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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
2014 54 54
2015 102 102
2016 96 96
2017 34 34
2018 9 9
2019 9 9
2020 92 92
2021 109 109
2022 21 21
2023 6 6
2024 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
Detachment of Device or Device Component 180 180
No Flow 92 92
Break 31 31
Leak/Splash 28 28
Obstruction of Flow 22 22
Device Operates Differently Than Expected 21 21
Infusion or Flow Problem 18 18
Occlusion Within Device 17 17
Device Contamination with Chemical or Other Material 13 13
Fluid/Blood Leak 12 12
Defective Device 12 12
Material Separation 9 9
Restricted Flow rate 8 8
Disconnection 7 7
Detachment Of Device Component 7 7
Crack 7 7
Device Damaged Prior to Use 7 7
Sediment, Precipitate Or Deposit In Device Or Device Ingredient 7 7
Material Integrity Problem 6 6
Fracture 6 6
Improper Flow or Infusion 6 6
Partial Blockage 5 5
Delivered as Unsterile Product 5 5
Improper Device Output 4 4
Connection Problem 4 4
Biofilm coating in Device 3 3
Collapse 3 3
Defective Component 3 3
Measurement System Incompatibility 3 3
Contamination /Decontamination Problem 3 3
Tear, Rip or Hole in Device Packaging 3 3
Product Quality Problem 3 3
Insufficient Flow or Under Infusion 2 2
Device Packaging Compromised 2 2
Component Missing 2 2
Use of Device Problem 2 2
Material Fragmentation 2 2
Unsealed Device Packaging 2 2
Difficult or Delayed Positioning 1 1
Out-Of-Box Failure 1 1
Positioning Failure 1 1
Device Disinfection Or Sterilization Issue 1 1
Shipping Damage or Problem 1 1
Decoupling 1 1
Contamination 1 1
Device Contamination With Biological Material 1 1
Positioning Problem 1 1
Difficult to Open or Close 1 1
Device Inoperable 1 1
Unintended Deflation 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 216 216
No Clinical Signs, Symptoms or Conditions 135 135
No Consequences Or Impact To Patient 89 89
No Patient Involvement 46 46
Urinary Retention 24 24
Insufficient Information 19 19
Missing Value Reason 7 7
Pain 5 5
No Information 4 4
Rupture 4 4
Foreign Body In Patient 4 4
Tissue Damage 4 4
Discomfort 3 3
Abdominal Distention 2 2
Obstruction/Occlusion 2 2
Confusion/ Disorientation 1 1
Unspecified Mental, Emotional or Behavioural Problem 1 1
Burning Sensation 1 1
Micturition Urgency 1 1
Dyspnea 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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