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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device thoracentesis tray
Regulation Description Hypodermic single lumen needle.
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
2021 10 10
2022 22 22
2023 10 10
2024 34 34
2025 52 52
2026 19 19

Device Problems MDRs with this Device Problem Events in those MDRs
Contamination 30 30
Break 23 23
Fluid/Blood Leak 11 11
Gas/Air Leak 9 9
Detachment of Device or Device Component 9 9
Complete Blockage 7 7
Material Twisted/Bent 7 7
Adverse Event Without Identified Device or Use Problem 6 6
Product Quality Problem 6 6
Leak/Splash 4 4
Device Markings/Labelling Problem 4 4
Retraction Problem 4 4
Image Orientation Incorrect 4 4
Insufficient Flow or Under Infusion 3 3
Material Separation 3 3
Disconnection 2 2
Crack 2 2
Material Puncture/Hole 2 2
Component Missing 2 2
Packaging Problem 2 2
Activation, Positioning or Separation Problem 1 1
Material Split, Cut or Torn 1 1
Separation Failure 1 1
Insufficient Information 1 1
Unsealed Device Packaging 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Difficult to Remove 1 1
Difficult to Insert 1 1
Material Discolored 1 1
Obstruction of Flow 1 1
Device Handling Problem 1 1
Fracture 1 1
Nonstandard Device 1 1
Loose or Intermittent Connection 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 114 114
Insufficient Information 18 18
Pneumothorax 13 13
Needle Stick/Puncture 3 3
Laceration(s) 3 3
Pain 2 2
Intra-Abdominal Hemorrhage 1 1
Cardiac Perforation 1 1
Foreign Body In Patient 1 1
Discomfort 1 1
No Consequences Or Impact To Patient 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Bard Peripheral Vascular Inc II Dec-05-2025
2 Bard Peripheral Vascular Inc II Jun-21-2022
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