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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
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
2014 2 2
2017 1 1
2018 3 3
2019 2 2
2020 2 2
2021 1 1
2022 5 5
2023 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Difficult to Advance 3 3
Occlusion Within Device 2 2
Break 2 2
Improper or Incorrect Procedure or Method 2 2
Suction Problem 2 2
Material Perforation 1 1
Defective Device 1 1
Detachment of Device or Device Component 1 1
Decrease in Suction 1 1
Fracture 1 1
Leak/Splash 1 1
Mechanical Problem 1 1
Use of Device Problem 1 1
Material Deformation 1 1
Material Twisted/Bent 1 1
Air/Gas in Device 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Death 3 3
No Clinical Signs, Symptoms or Conditions 3 3
Pneumothorax 2 2
No Known Impact Or Consequence To Patient 2 2
Insufficient Information 2 2
Cardiac Arrest 1 1
No Code Available 1 1
Pleural Empyema 1 1
No Consequences Or Impact To Patient 1 1
Overinflation of Lung 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Atrium Medical Corporation II Jan-24-2017
2 Atrium Medical Corporation II Jun-29-2015
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