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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
2014 11 11
2017 1 1
2018 5 5
2019 1 1
2020 6 6
2021 2 2
2023 5 5

Device Problems MDRs with this Device Problem Events in those MDRs
Detachment of Device or Device Component 6 6
No Flow 4 4
Unintended Deflation 4 4
Packaging Problem 3 3
Incomplete or Missing Packaging 3 3
Misassembled 3 3
Leak/Splash 2 2
Defective Device 2 2
Device Operates Differently Than Expected 2 2
Obstruction of Flow 1 1
Separation Problem 1 1
Device Markings/Labelling Problem 1 1
No Device Output 1 1
Difficult to Remove 1 1
Retraction Problem 1 1
Material Rupture 1 1
Partial Blockage 1 1
Detachment Of Device Component 1 1
Material Discolored 1 1
Fluid/Blood Leak 1 1
Kinked 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 8 8
No Known Impact Or Consequence To Patient 6 6
No Patient Involvement 4 4
Unspecified Infection 3 3
Urinary Retention 3 3
No Information 2 2
No Code Available 2 2
Device Embedded In Tissue or Plaque 1 1
Exposure to Body Fluids 1 1
Vomiting 1 1
No Consequences Or Impact To Patient 1 1
Organ Dehiscence 1 1
Pain 1 1
Swelling 1 1
Foreign Body In Patient 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Cardinal Health 200, LLC I Feb-16-2024
2 Mckesson Medical-Surgical Inc. Corporate Office II Aug-26-2022
3 SteriGear, LLC II Jun-23-2014
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