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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

Device Problems MDRs with this Device Problem Events in those MDRs
Fluid/Blood Leak 89 89
Break 66 66
Leak/Splash 42 42
Crack 37 37
Fracture 9 9
Material Fragmentation 9 9
Material Puncture/Hole 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
Infusion or Flow Problem 5 5
Migration 5 5
Material Split, Cut or Torn 5 5
Complete Blockage 5 5
Device Markings/Labelling Problem 4 4
Material Separation 4 4
Use of Device Problem 4 4
Patient Device Interaction Problem 4 4
Air/Gas in Device 3 3
Defective Device 3 3
Backflow 3 3
Hole In Material 2 2
Disconnection 2 2
Malposition of Device 2 2
Material Perforation 2 2
Material Rupture 2 2
Material Integrity Problem 2 2
Positioning Problem 2 2
Appropriate Term/Code Not Available 1 1
Output Problem 1 1
Material Deformation 1 1
Separation Problem 1 1
Inaccurate Information 1 1
Unclear Information 1 1
Component Missing 1 1
Stretched 1 1
Difficult to Remove 1 1
Material Too Rigid or Stiff 1 1
Moisture Damage 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
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 45 45
No Information 26 26
Insufficient Information 20 20
Foreign Body In Patient 17 17
Device Embedded In Tissue or Plaque 13 13
Blood Loss 12 12
Hemorrhage/Bleeding 9 9
Extravasation 4 4
Pericardial Effusion 4 4
No Code Available 3 3
Hypoglycemia 3 3
Fluid Discharge 3 3
Low Blood Pressure/ Hypotension 2 2
Liver Contusion 2 2
Death 2 2
Pleural Effusion 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
Abdominal Distention 2 2
Perforation of Vessels 2 2
Vomiting 1 1
No Patient Involvement 1 1
Patient Problem/Medical Problem 1 1
Unspecified Kidney or Urinary Problem 1 1
Angioedema 1 1
Drug Resistant Bacterial Infection 1 1
Renal Failure 1 1
Sepsis 1 1
Septic Shock 1 1
Tachycardia 1 1
Cardiac Tamponade 1 1
Cardiogenic Shock 1 1
Irritability 1 1
Missed Dose 1 1
Air Embolism 1 1
Bacterial Infection 1 1
Liver Laceration(s) 1 1

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