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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 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
Material Fragmentation 8 8
Leak/Splash 8 8
Material Split, Cut or Torn 8 8
Migration 7 7
Detachment of Device or Device Component 7 7
Adverse Event Without Identified Device or Use Problem 6 6
Positioning Problem 5 5
Fracture 5 5
Malposition of Device 4 4
Material Separation 4 4
Obstruction of Flow 4 4
Use of Device Problem 4 4
Complete Blockage 4 4
Backflow 3 3
Device Markings/Labelling Problem 3 3
Air/Gas in Device 3 3
Patient Device Interaction 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
Improper Flow or Infusion 1 1
Positioning Failure 1 1
Product Quality Problem 1 1
Material Deformation 1 1
Infusion or Flow Problem 1 1
Disconnection 1 1
Stretched 1 1
Separation Problem 1 1
Separation Failure 1 1
Output Problem 1 1
Migration or Expulsion of Device 1 1
Entrapment of Device 1 1
Unclear Information 1 1
Insufficient Information 1 1
Material Integrity Problem 1 1
Difficult to Remove 1 1
Moisture Damage 1 1
Inaccurate Information 1 1
Difficult to Flush 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
Hemorrhage/Bleeding 9 9
Blood Loss 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
No Code Available 2 2
Low Blood Pressure/ Hypotension 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
Pain 1 1
Unspecified Kidney or Urinary Problem 1 1
Discomfort 1 1
Cardiogenic Shock 1 1
Septic Shock 1 1
No Patient Involvement 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
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