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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
COVIDIEN LP, FORMERLY REGISTERED AS KENDALL
  SUBSTANTIALLY EQUIVALENT 1
FOOTPRINT MEDICAL
  SUBSTANTIALLY EQUIVALENT 2
FOOTPRINT MEDICAL INC.
  SUBSTANTIALLY EQUIVALENT 1
HAOLANG MEDICAL USA CORPORATION
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2014 69 69
2015 81 81
2016 115 115
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 219 219
Fluid/Blood Leak 200 200
Break 131 131
Crack 92 92
Hole In Material 27 27
Material Fragmentation 17 17
Connection Problem 16 16
Fracture 14 14
Material Puncture/Hole 13 13
Detachment of Device or Device Component 10 10
Air Leak 10 10
Material Split, Cut or Torn 8 8
Malposition of Device 8 8
Adverse Event Without Identified Device or Use Problem 8 8
Detachment Of Device Component 7 7
Device Operates Differently Than Expected 7 7
Migration 7 7
Complete Blockage 7 7
Obstruction of Flow 7 7
Use of Device Problem 7 7
Backflow 7 7
Defective Device 7 7
Positioning Problem 7 7
Material Separation 6 6
Infusion or Flow Problem 6 6
Difficult to Remove 6 6
Entrapment of Device 5 5
Split 5 5
Device Markings/Labelling Problem 5 5
Bent 5 5
Improper Flow or Infusion 5 5
Material Integrity Problem 5 5
Improper or Incorrect Procedure or Method 4 4
Appropriate Term/Code Not Available 4 4
Patient Device Interaction Problem 4 4
Disconnection 4 4
Insufficient Information 4 4
Migration or Expulsion of Device 4 4
Air/Gas in Device 3 3
Material Perforation 3 3
Moisture Damage 2 2
Difficult to Insert 2 2
Device Displays Incorrect Message 2 2
Occlusion Within Device 2 2
Gas/Air Leak 2 2
Structural Problem 2 2
Device Dislodged or Dislocated 2 2
Reflux within Device 2 2
Kinked 2 2
Material Rupture 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 274 274
No Consequences Or Impact To Patient 123 123
No Clinical Signs, Symptoms or Conditions 82 82
No Information 60 60
Foreign Body In Patient 26 26
Hemorrhage/Bleeding 26 26
Blood Loss 25 25
Insufficient Information 24 24
Device Embedded In Tissue or Plaque 23 23
No Code Available 18 18
Death 12 12
No Patient Involvement 11 11
Pericardial Effusion 6 6
Air Embolism 6 6
Extravasation 5 5
Abdominal Distention 4 4
Low Blood Pressure/ Hypotension 3 3
Ischemia 3 3
Sepsis 3 3
Pleural Effusion 3 3
Fluid Discharge 3 3
Hypoglycemia 3 3
Cardiac Tamponade 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
Discomfort 2 2
Liver Contusion 2 2
Pain 2 2
Shock 2 2
Perforation of Vessels 2 2
Low Oxygen Saturation 1 1
Internal Organ Perforation 1 1
Ascites 1 1
Bacterial Infection 1 1
Irritability 1 1
Lethargy 1 1
Distress 1 1
Infiltration into Tissue 1 1
Extubate 1 1
Liver Laceration(s) 1 1
Angioedema 1 1
Skin Tears 1 1
Swelling/ Edema 1 1
Tachycardia 1 1
Renal Failure 1 1
Unspecified Kidney or Urinary Problem 1 1
Cardiogenic Shock 1 1
Septic Shock 1 1
Vomiting 1 1
Intracranial Hemorrhage 1 1
Injury 1 1

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