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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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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
2018 84 84
2019 64 64
2020 43 43
2021 49 49
2022 38 38
2023 8 8

Device Problems MDRs with this Device Problem Events in those MDRs
Fluid/Blood Leak 90 90
Break 69 69
Leak/Splash 42 42
Crack 37 37
Material Puncture/Hole 11 11
Fracture 9 9
Material Fragmentation 9 9
Detachment of Device or Device Component 8 8
Obstruction of Flow 6 6
Adverse Event Without Identified Device or Use Problem 6 6
Material Split, Cut or Torn 6 6
Migration 5 5
Infusion or Flow Problem 5 5
Complete Blockage 5 5
Use of Device Problem 4 4
Device Markings/Labelling Problem 4 4
Material Separation 4 4
Patient Device Interaction Problem 4 4
Positioning Problem 3 3
Defective Device 3 3
Air/Gas in Device 3 3
Backflow 3 3
Hole In Material 2 2
Disconnection 2 2
Material Perforation 2 2
Malposition of Device 2 2
Material Rupture 2 2
Material Integrity Problem 2 2
Output Problem 1 1
Material Deformation 1 1
Appropriate Term/Code Not Available 1 1
Separation Problem 1 1
Inaccurate Information 1 1
Unclear Information 1 1
Component Missing 1 1
Structural Problem 1 1
Separation Failure 1 1
Filtration Problem 1 1
Gas/Air Leak 1 1
Improper Flow or Infusion 1 1
Stretched 1 1
Migration or Expulsion of Device 1 1
Moisture Damage 1 1
Product Quality Problem 1 1
Difficult to Remove 1 1
Material Too Rigid or Stiff 1 1
Entrapment of Device 1 1
Unintended Ejection 1 1
Difficult to Flush 1 1
Flushing Problem 1 1
Difficult to Insert 1 1
Air Leak 1 1
Burst Container or Vessel 1 1
Detachment Of Device Component 1 1
Positioning Failure 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 64 64
No Known Impact Or Consequence To Patient 52 52
No Clinical Signs, Symptoms or Conditions 50 50
No Information 26 26
Insufficient Information 21 21
Foreign Body In Patient 19 19
Device Embedded In Tissue or Plaque 13 13
Blood Loss 12 12
Hemorrhage/Bleeding 10 10
Pericardial Effusion 4 4
Extravasation 4 4
No Code Available 3 3
Fluid Discharge 3 3
Hypoglycemia 3 3
Abdominal Distention 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
Low Blood Pressure/ Hypotension 2 2
Death 2 2
Liver Contusion 2 2
Perforation of Vessels 2 2
Pleural Effusion 2 2
Tachycardia 1 1
No Patient Involvement 1 1
Unspecified Kidney or Urinary Problem 1 1
Angioedema 1 1
Drug Resistant Bacterial Infection 1 1
Sepsis 1 1
Liver Laceration(s) 1 1
Irritability 1 1
Septic Shock 1 1
Missed Dose 1 1
Renal Failure 1 1
Patient Problem/Medical Problem 1 1
Bacterial Infection 1 1
Air Embolism 1 1
Cardiac Tamponade 1 1
Vomiting 1 1
Cardiogenic Shock 1 1

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