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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device thoracentesis tray
Definition This product code has been established in accordance with the May 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.
Product CodePXI
Regulation Number 880.5570
Device Class 2

MDR Year MDR Reports MDR Events
2019 1 1
2020 4 4
2021 10 10
2022 22 22
2023 10 10
2024 8 8

Device Problems MDRs with this Device Problem Events in those MDRs
Break 11 11
Detachment of Device or Device Component 6 6
Material Twisted/Bent 5 5
Material Separation 5 5
Product Quality Problem 5 5
Adverse Event Without Identified Device or Use Problem 5 5
Retraction Problem 3 3
Leak/Splash 2 2
Complete Blockage 2 2
Disconnection 2 2
Fluid/Blood Leak 2 2
Image Orientation Incorrect 2 2
Component Missing 2 2
Device Markings/Labelling Problem 2 2
Manufacturing, Packaging or Shipping Problem 1 1
No Flow 1 1
Separation Failure 1 1
Activation, Positioning or Separation Problem 1 1
Difficult to Insert 1 1
Unsealed Device Packaging 1 1
Material Puncture/Hole 1 1
Device Handling Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 34 34
Pneumothorax 10 10
Insufficient Information 10 10
No Consequences Or Impact To Patient 3 3
Needle Stick/Puncture 2 2
Cardiac Perforation 1 1
Foreign Body In Patient 1 1
Intra-Abdominal Hemorrhage 1 1
Discomfort 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Bard Peripheral Vascular Inc II Jun-21-2022
2 Carefusion 2200 Inc II Jul-20-2020
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