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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
2017 139 139
2018 84 84
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
Leak/Splash 140 140
Fluid/Blood Leak 111 111
Break 91 91
Crack 47 47
Material Puncture/Hole 13 13
Material Fragmentation 12 12
Connection Problem 11 11
Fracture 10 10
Hole In Material 9 9
Detachment of Device or Device Component 9 9
Material Split, Cut or Torn 8 8
Adverse Event Without Identified Device or Use Problem 7 7
Obstruction of Flow 7 7
Migration 7 7
Complete Blockage 6 6
Positioning Problem 6 6
Use of Device Problem 6 6
Infusion or Flow Problem 5 5
Material Separation 5 5
Malposition of Device 4 4
Device Markings/Labelling Problem 4 4
Appropriate Term/Code Not Available 4 4
Defective Device 4 4
Material Integrity Problem 4 4
Patient Device Interaction Problem 4 4
Backflow 3 3
Difficult to Remove 3 3
Air/Gas in Device 3 3
Material Perforation 2 2
Material Rupture 2 2
Occlusion Within Device 2 2
Gas/Air Leak 2 2
Improper Flow or Infusion 2 2
Air Leak 2 2
Improper or Incorrect Procedure or Method 2 2
Migration or Expulsion of Device 2 2
Disconnection 2 2
Product Quality Problem 1 1
Device Dislodged or Dislocated 1 1
Flushing Problem 1 1
Material Deformation 1 1
Inaccurate Information 1 1
Device Displays Incorrect Message 1 1
Structural Problem 1 1
Detachment Of Device Component 1 1
Positioning Failure 1 1
Material Too Rigid or Stiff 1 1
Unintended Ejection 1 1
Component Missing 1 1
Difficult to Insert 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 112 112
No Consequences Or Impact To Patient 105 105
No Clinical Signs, Symptoms or Conditions 82 82
No Information 39 39
Foreign Body In Patient 26 26
Insufficient Information 24 24
Device Embedded In Tissue or Plaque 16 16
Blood Loss 15 15
Hemorrhage/Bleeding 12 12
No Patient Involvement 8 8
Air Embolism 6 6
Pericardial Effusion 6 6
Death 4 4
No Code Available 4 4
Extravasation 4 4
Abdominal Distention 3 3
Pleural Effusion 3 3
Fluid Discharge 3 3
Hypoglycemia 3 3
Liver Contusion 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
Low Blood Pressure/ Hypotension 2 2
Cardiac Tamponade 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
Irritability 1 1
Skin Tears 1 1
Swelling/ Edema 1 1
Tachycardia 1 1
Renal Failure 1 1
Pain 1 1
Unspecified Kidney or Urinary Problem 1 1
Discomfort 1 1
Cardiogenic Shock 1 1
Septic Shock 1 1
Vomiting 1 1
Intracranial Hemorrhage 1 1
Injury 1 1
Respiratory Acidosis 1 1
Anemia 1 1
Hematoma 1 1
Missed Dose 1 1
Sepsis 1 1
Failure of Implant 1 1
Drug Resistant Bacterial Infection 1 1
Patient Problem/Medical Problem 1 1

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