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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 45 45

Device Problems MDRs with this Device Problem Events in those MDRs
Fluid/Blood Leak 89 89
Break 67 67
Crack 32 32
Connection Problem 16 16
Material Puncture/Hole 9 9
Leak/Splash 8 8
Material Split, Cut or Torn 8 8
Material Fragmentation 8 8
Migration 7 7
Detachment of Device or Device Component 7 7
Adverse Event Without Identified Device or Use Problem 6 6
Fracture 5 5
Positioning Problem 5 5
Obstruction of Flow 5 5
Malposition of Device 4 4
Complete Blockage 4 4
Material Separation 4 4
Use of Device Problem 4 4
Device Markings/Labelling Problem 3 3
Patient Device Interaction Problem 3 3
Air/Gas in Device 3 3
Backflow 3 3
Defective Device 2 2
Material Perforation 2 2
Gas/Air Leak 2 2
Inaccurate Information 1 1
Product Quality Problem 1 1
Material Deformation 1 1
Infusion or Flow Problem 1 1
Improper Flow or Infusion 1 1
Component Missing 1 1
Material Too Rigid or Stiff 1 1
Positioning Failure 1 1
Stretched 1 1
Difficult to Remove 1 1
Moisture Damage 1 1
Material Integrity Problem 1 1
Unclear Information 1 1
Insufficient Information 1 1
Separation Failure 1 1
Difficult to Flush 1 1
Output Problem 1 1
Migration or Expulsion of Device 1 1
Entrapment of Device 1 1
Separation Problem 1 1
Disconnection 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 90 90
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 21 21
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
Pain 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
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
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