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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
Regulation Description Urine collector and accessories.
Product CodeFCN
Regulation Number 876.5250
Device Class 2

MDR Year MDR Reports MDR Events
2021 2 2
2023 5 5
2024 1 1
2025 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Unintended Deflation 4 4
Detachment of Device or Device Component 2 2
Obstruction of Flow 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Material Rupture 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 8 8
Internal Organ Perforation 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
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