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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device urinary drainage collection kit, for indwelling catheter
Product CodeFCN
Regulation Number 876.5250
Device Class 2

MDR Year MDR Reports MDR Events
2018 5 5
2019 1 1
2020 6 6
2021 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
Detachment of Device or Device Component 6 6
Leak/Splash 2 2
Difficult to Remove 1 1
Retraction Problem 1 1
Material Separation 1 1
Defective Device 1 1
No Flow 1 1
Separation Problem 1 1
Detachment Of Device Component 1 1
Fluid/Blood Leak 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Patient Involvement 4 4
No Clinical Signs, Symptoms or Conditions 4 4
Foreign Body In Patient 1 1
No Known Impact Or Consequence To Patient 1 1
Device Embedded In Tissue or Plaque 1 1
No Information 1 1
Exposure to Body Fluids 1 1
Pain 1 1
Urinary Retention 1 1
No Consequences Or Impact To Patient 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Mckesson Medical-Surgical Inc. Corporate Office II Aug-26-2022
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