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 catheter, umbilical artery
Product CodeFOS
Regulation Number 880.5200
Device Class 2


Premarket Reviews
ManufacturerDecision
HAOLANG MEDICAL USA CORPORATION
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 64 64
2020 43 43
2021 49 49
2022 38 38
2023 20 20
2024 34 34

Device Problems MDRs with this Device Problem Events in those MDRs
Fluid/Blood Leak 86 86
Break 62 62
Crack 31 31
Connection Problem 10 10
Material Puncture/Hole 9 9
Leak/Splash 8 8
Material Split, Cut or Torn 8 8
Material Fragmentation 8 8
Detachment of Device or Device Component 7 7
Migration 7 7
Adverse Event Without Identified Device or Use Problem 6 6
Fracture 5 5
Positioning Problem 5 5
Malposition of Device 4 4
Complete Blockage 4 4
Material Separation 4 4
Use of Device Problem 4 4
Obstruction of Flow 4 4
Air/Gas in Device 3 3
Patient Device Interaction Problem 3 3
Backflow 3 3
Device Markings/Labelling Problem 3 3
Gas/Air Leak 2 2
Material Perforation 2 2
Defective Device 2 2
Component Missing 1 1
Material Too Rigid or Stiff 1 1
Positioning Failure 1 1
Improper Flow or Infusion 1 1
Stretched 1 1
Infusion or Flow Problem 1 1
Material Deformation 1 1
Material Integrity Problem 1 1
Product Quality Problem 1 1
Insufficient Information 1 1
Separation Failure 1 1
Unclear Information 1 1
Difficult to Flush 1 1
Separation Problem 1 1
Disconnection 1 1
Migration or Expulsion of Device 1 1
Difficult to Remove 1 1
Moisture Damage 1 1
Output Problem 1 1
Inaccurate Information 1 1
Entrapment of Device 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 80 80
No Consequences Or Impact To Patient 42 42
No Known Impact Or Consequence To Patient 24 24
Insufficient Information 24 24
Foreign Body In Patient 20 20
Device Embedded In Tissue or Plaque 11 11
No Information 10 10
Blood Loss 9 9
Hemorrhage/Bleeding 9 9
Pericardial Effusion 5 5
Extravasation 4 4
Abdominal Distention 3 3
Hypoglycemia 3 3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
Death 2 2
Low Blood Pressure/ Hypotension 2 2
No Code Available 2 2
Cardiac Tamponade 2 2
Pleural Effusion 2 2
Perforation of Vessels 2 2
Angioedema 1 1
Liver Laceration(s) 1 1
Low Oxygen Saturation 1 1
Ascites 1 1
Bacterial Infection 1 1
Skin Tears 1 1
Swelling/ Edema 1 1
Tachycardia 1 1
Renal Failure 1 1
Fluid Discharge 1 1
Unspecified Kidney or Urinary Problem 1 1
Pain 1 1
No Patient Involvement 1 1
Discomfort 1 1
Cardiogenic Shock 1 1
Septic Shock 1 1
Intracranial Hemorrhage 1 1
Respiratory Acidosis 1 1
Hematoma 1 1
Missed Dose 1 1
Sepsis 1 1
Drug Resistant Bacterial Infection 1 1
Patient Problem/Medical Problem 1 1
Liver Contusion 1 1
Air Embolism 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Cardinal Health 200, LLC I Aug-13-2021
-
-