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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
Regulation Description Intravascular catheter.
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
2016 115 115
2017 139 139
2018 84 84
2019 64 64
2020 43 43
2021 39 39

Device Problems MDRs with this Device Problem Events in those MDRs
Leak/Splash 161 161
Fluid Leak 136 136
Break 81 81
Crack 68 68
Hole In Material 17 17
Fracture 13 13
Material Fragmentation 13 13
Air Leak 9 9
Material Puncture/Hole 8 8
Detachment of Device or Device Component 7 7
Adverse Event Without Identified Device or Use Problem 6 6
Backflow 6 6
Use of Device Problem 6 6
Complete Blockage 6 6
Bent 5 5
Obstruction of Flow 5 5
Material Integrity Problem 5 5
Appropriate Term/Code Not Available 4 4
Patient Device Interaction Problem 4 4
Migration 4 4
Improper Flow or Infusion 4 4
Infusion or Flow Problem 4 4
Device Operates Differently Than Expected 4 4
Material Separation 4 4
Connection Problem 4 4
Device Markings/Labelling Problem 3 3
Malposition of Device 3 3
Positioning Problem 3 3
Improper or Incorrect Procedure or Method 3 3
Detachment Of Device Component 3 3
Entrapment of Device 2 2
Split 2 2
Kinked 2 2
Difficult to Remove 2 2
Occlusion Within Device 2 2
Material Rupture 2 2
Device Dislodged or Dislocated 2 2
Defective Device 2 2
Device Displays Incorrect Message 2 2
Material Split, Cut or Torn 2 2
Separation Problem 1 1
Inaccurate Information 1 1
Unclear Information 1 1
Folded 1 1
Filtration Problem 1 1
Gas Leak 1 1
Torn Material 1 1
Material Deformation 1 1
Material Too Rigid or Stiff 1 1
Migration or Expulsion of Device 1 1
Moisture Damage 1 1
Separation Failure 1 1
Structural Problem 1 1
Material Perforation 1 1
Defective Component 1 1
Component Missing 1 1
Unintended Ejection 1 1
Difficult to Flush 1 1
Flushing Problem 1 1
Difficult to Insert 1 1
Positioning Failure 1 1
Disconnection 1 1
Burst Container or Vessel 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 189 189
No Consequences Or Impact To Patient 109 109
No Information 50 50
Blood Loss 23 23
No Clinical Signs, Symptoms or Conditions 21 21
Device Embedded In Tissue or Plaque 17 17
Foreign Body In Patient 12 12
No Patient Involvement 10 10
Insufficient Information 10 10
No Code Available 9 9
Hemorrhage/Bleeding 7 7
Air Embolism 6 6
Pericardial Effusion 5 5
Extravasation 5 5
Death 5 5
Hypoglycemia 2 2
Liver Contusion 2 2
Pleural Effusion 2 2
Abdominal Distention 2 2
Fluid Discharge 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
Anemia 1 1
Exsanguination 1 1
Cardiac Tamponade 1 1
Missed Dose 1 1
Low Blood Pressure/ Hypotension 1 1
Failure of Implant 1 1
Infiltration into Tissue 1 1
Renal Failure 1 1
Sepsis 1 1
Septic Shock 1 1
Perforation of Vessels 1 1
Tachycardia 1 1
Vomiting 1 1
Cardiogenic Shock 1 1
Distress 1 1
Injury 1 1
Irritability 1 1
Liver Laceration(s) 1 1
Foreign Body Reaction 1 1
Patient Problem/Medical Problem 1 1
Bacterial Infection 1 1
Unspecified Kidney or Urinary Problem 1 1
Angioedema 1 1
Drug Resistant Bacterial Infection 1 1

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