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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device chest drainage kit
Regulation Description Vacuum-powered body fluid suction apparatus.
Definition This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html. This kit, as described in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market.
Product CodePAD
Regulation Number 880.6740
Device Class 2

MDR Year MDR Reports MDR Events
2021 1 4
2022 5 5
2023 1 1
2025 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Difficult to Advance 3 3
Leak/Splash 1 1
Break 1 1
Defective Device 1 4
Air/Gas in Device 1 1
Incorrect Measurement 1 1
Fracture 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 4 4
Insufficient Information 2 5
Pleural Empyema 1 1
Overinflation of Lung 1 1

Recalls
Manufacturer Recall Class Date Posted
1 MEDLINE INDUSTRIES, LP - Northfield II Apr-17-2025
2 MEDLINE INDUSTRIES, LP - Northfield II Sep-06-2024
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