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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
2019 64 64
2020 43 43
2021 49 49
2022 38 38
2023 20 20
2024 8 8

Device Problems MDRs with this Device Problem Events in those MDRs
Fluid/Blood Leak 81 81
Break 60 60
Crack 30 30
Material Puncture/Hole 9 9
Material Fragmentation 8 8
Leak/Splash 8 8
Material Split, Cut or Torn 8 8
Detachment of Device or Device Component 7 7
Migration 6 6
Positioning Problem 5 5
Adverse Event Without Identified Device or Use Problem 5 5
Fracture 5 5
Material Separation 4 4
Use of Device Problem 4 4
Malposition of Device 4 4
Complete Blockage 4 4
Device Markings/Labelling Problem 3 3
Obstruction of Flow 3 3
Backflow 3 3
Patient Device Interaction Problem 3 3
Air/Gas in Device 3 3
Material Perforation 2 2
Defective Device 2 2
Output Problem 1 1
Gas/Air Leak 1 1
Improper Flow or Infusion 1 1
Infusion or Flow Problem 1 1
Material Deformation 1 1
Material Integrity Problem 1 1
Component Missing 1 1
Separation Failure 1 1
Stretched 1 1
Difficult to Flush 1 1
Positioning Failure 1 1
Disconnection 1 1
Entrapment of Device 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
Separation Problem 1 1
Inaccurate Information 1 1
Unclear Information 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 60 60
No Consequences Or Impact To Patient 42 42
No Known Impact Or Consequence To Patient 24 24
Insufficient Information 21 21
Foreign Body In Patient 19 19
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
Hypoglycemia 3 3
Abdominal Distention 3 3
Death 2 2
Perforation of Vessels 2 2
No Code Available 2 2
Low Blood Pressure/ Hypotension 2 2
Cardiac Tamponade 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
Cardiogenic Shock 1 1
Low Oxygen Saturation 1 1
Skin Tears 1 1
Missed Dose 1 1
Hematoma 1 1
Air Embolism 1 1
Bacterial Infection 1 1
Liver Contusion 1 1
Liver Laceration(s) 1 1
Pleural Effusion 1 1
Renal Failure 1 1
Sepsis 1 1
Septic Shock 1 1
Tachycardia 1 1
Unspecified Kidney or Urinary Problem 1 1
Angioedema 1 1
Drug Resistant Bacterial Infection 1 1
Swelling/ Edema 1 1
Patient Problem/Medical Problem 1 1
No Patient Involvement 1 1
Fluid Discharge 1 1

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