Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search show TPLC since Back to Search Results
Device fluid drainage tray
Regulation Description Introduction/drainage catheter and accessories.
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 CodePXU
Regulation Number 878.4200
Device Class 1

MDR Year MDR Reports MDR Events
2021 3 3
2022 4 4
2023 1 1
2024 1 1
2025 6 6

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 6 6
Material Separation 3 3
Fracture 3 3
Break 2 2
Material Integrity Problem 2 2
Material Too Rigid or Stiff 1 1
No Apparent Adverse Event 1 1
Gas/Air Leak 1 1
Obstruction of Flow 1 1
Use of Device Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 6 6
Foreign Body In Patient 3 3
Cardiac Arrest 2 2
Cardiac Tamponade 2 2
Pleural Effusion 1 1
Hemorrhage/Blood Loss/Bleeding 1 1
Arrhythmia 1 1
Discomfort 1 1
Pericardial Effusion 1 1
Exsanguination 1 1
Angina 1 1
Perforation 1 1
Ischemia 1 1
Cardiovascular Dysfunction/Insufficiency 1 1
Hemodynamic instability 1 1
Pneumoperitoneum 1 1
Cardiac Perforation 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Merit Medical Systems, Inc. II Aug-12-2024
-
-