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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 8 8

Device Problems MDRs with this Device Problem Events in those MDRs
Leak/Splash 219 219
Fluid/Blood Leak 195 195
Break 129 129
Crack 91 91
Hole In Material 27 27
Material Fragmentation 17 17
Fracture 14 14
Material Puncture/Hole 13 13
Air Leak 10 10
Detachment of Device or Device Component 10 10
Malposition of Device 8 8
Material Split, Cut or Torn 8 8
Defective Device 7 7
Device Operates Differently Than Expected 7 7
Adverse Event Without Identified Device or Use Problem 7 7
Positioning Problem 7 7
Complete Blockage 7 7
Detachment Of Device Component 7 7
Backflow 7 7
Use of Device Problem 7 7
Material Separation 6 6
Difficult to Remove 6 6
Migration 6 6
Infusion or Flow Problem 6 6
Connection Problem 6 6
Obstruction of Flow 6 6
Split 5 5
Device Markings/Labelling Problem 5 5
Improper Flow or Infusion 5 5
Material Integrity Problem 5 5
Entrapment of Device 5 5
Bent 5 5
Disconnection 4 4
Improper or Incorrect Procedure or Method 4 4
Migration or Expulsion of Device 4 4
Appropriate Term/Code Not Available 4 4
Patient Device Interaction Problem 4 4
Insufficient Information 3 3
Material Perforation 3 3
Air/Gas in Device 3 3
Structural Problem 2 2
Device Displays Incorrect Message 2 2
Torn Material 2 2
Material Deformation 2 2
Device Dislodged or Dislocated 2 2
Filtration Problem 2 2
Moisture Damage 2 2
Occlusion Within Device 2 2
Difficult to Insert 2 2
Kinked 2 2
Reflux within Device 2 2
Material Rupture 2 2
Incorrect, Inadequate or Imprecise Result or Readings 1 1
Material Too Rigid or Stiff 1 1
Fitting Problem 1 1
Stretched 1 1
Product Quality Problem 1 1
Difficult To Position 1 1
Unintended Ejection 1 1
Difficult to Flush 1 1
Flushing Problem 1 1
Burst Container or Vessel 1 1
Component Falling 1 1
Positioning Failure 1 1
Gas/Air Leak 1 1
Unintended Movement 1 1
Output Problem 1 1
Folded 1 1
Defective Component 1 1
Component Missing 1 1
Device Contamination with Body Fluid 1 1
Separation Failure 1 1
Cut In Material 1 1
Incorrect Or Inadequate Test Results 1 1
Separation Problem 1 1
Inaccurate Information 1 1
Unclear Information 1 1

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 62 62
No Information 60 60
Hemorrhage/Bleeding 26 26
Foreign Body In Patient 25 25
Blood Loss 25 25
Device Embedded In Tissue or Plaque 23 23
Insufficient Information 21 21
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
Fluid Discharge 3 3
Hypoglycemia 3 3
Low Blood Pressure/ Hypotension 3 3
Ischemia 3 3
Sepsis 3 3
Pleural Effusion 2 2
Shock 2 2
Perforation of Vessels 2 2
Cardiac Tamponade 2 2
Liver Contusion 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
Unspecified Kidney or Urinary Problem 1 1
Angioedema 1 1
Drug Resistant Bacterial Infection 1 1
Swelling/ Edema 1 1
Patient Problem/Medical Problem 1 1
Test Result 1 1
Liver Damage/Dysfunction 1 1
Liver Laceration(s) 1 1
Internal Organ Perforation 1 1
Pain 1 1
Failure of Implant 1 1
Infiltration into Tissue 1 1
Foreign Body Reaction 1 1
Hematoma 1 1
Exsanguination 1 1
Anemia 1 1
Bacterial Infection 1 1
Coagulation Disorder 1 1
Cardiogenic Shock 1 1
Distress 1 1
Discomfort 1 1
Complaint, Ill-Defined 1 1
Injury 1 1
Extubate 1 1
Irritability 1 1
Low Oxygen Saturation 1 1
Skin Tears 1 1
Lethargy 1 1
Missed Dose 1 1
Vomiting 1 1
Tachycardia 1 1
Renal Failure 1 1
Septic Shock 1 1

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