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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device stopcock, i.v. set
Regulation Description Intravascular administration set.
Product CodeFMG
Regulation Number 880.5440
Device Class 2


Premarket Reviews
ManufacturerDecision
DYNAREX
  SUBSTANTIALLY EQUIVALENT 1
ELCAM MEDICAL ACAL
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2015 96 96
2016 148 148
2017 114 114
2018 164 164
2019 400 400
2020 214 214

Device Problems MDRs with this Device Problem Events in those MDRs
Fluid Leak 373 373
Leak/Splash 287 287
Disconnection 106 106
Stopcock 86 86
Crack 70 70
Tube 60 60
Device Contamination with Chemical or Other Material 54 54
Break 53 53
Connection Problem 37 37
Connector 36 36
Failure to Prime 34 34
Loose or Intermittent Connection 30 30
Infusion or Flow Problem 23 23
Detachment of Device or Device Component 22 22
Detachment Of Device Component 20 20
Stopcock Valve 16 16
No Flow 13 13
Device Operates Differently Than Expected 11 11
Valve(s) 11 11
Device Damaged Prior to Use 11 11
Particulates 10 10
Gas Leak 10 10
Cap 10 10
Material Separation 10 10
Port 9 9
Mechanical Problem 8 8
Complete Blockage 8 8
Improper Flow or Infusion 8 8
Device Dislodged or Dislocated 7 7
Air Leak 7 7
Backflow 7 7
Kinked 6 6
Hole In Material 6 6
Excess Flow or Over-Infusion 6 6
Packaging Problem 6 6
Material Twisted/Bent 6 6
Fracture 5 5
Manifold 5 5
Filling Problem 5 5
Reflux within Device 5 5
Failure to Disconnect 5 5
Contamination /Decontamination Problem 5 5
Free or Unrestricted Flow 4 4
Failure to Infuse 4 4
Partial Blockage 4 4
Y-Piece Connector 4 4
Defective Device 4 4
Blocked Connection 4 4
Material Protrusion/Extrusion 3 3
Material Split, Cut or Torn 3 3
Bent 3 3
Flushing Problem 3 3
Plug 3 3
Improper or Incorrect Procedure or Method 3 3
Defective Component 3 3
Material Deformation 3 3
Physical Resistance/Sticking 3 3
Adverse Event Without Identified Device or Use Problem 3 3
Insufficient Flow or Under Infusion 2 2
Dent in Material 2 2
Device Markings/Labelling Problem 2 2
Housing 2 2
Knob 2 2
Hub 2 2
Component Falling 2 2
Luer Valve 2 2
Burst Container or Vessel 2 2
Tip 2 2
Device Packaging Compromised 2 2
Material Puncture/Hole 2 2
Retraction Problem 2 2
Split 2 2
Physical Property Issue 2 2
Protective Measures Problem 2 2
Catheter 1 1
Hose 1 1
Physical Resistance 1 1
Deformation Due to Compressive Stress 1 1
Unintended Ejection 1 1
Disassembly 1 1
Loss of or Failure to Bond 1 1
Clamp 1 1
Filter 1 1
Junction 1 1
Regulator 1 1
Material Fragmentation 1 1
Material Opacification 1 1
Use of Device Problem 1 1
Suction Problem 1 1
Component Missing 1 1
Failure to Deliver 1 1
Inaccurate Delivery 1 1
Obstruction of Flow 1 1
Structural Problem 1 1
Contamination 1 1
Misassembled 1 1
Occlusion Within Device 1 1
Defective Alarm 1 1
Aspiration Issue 1 1
Incorrect Device Or Component Shipped 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 478 478
No Consequences Or Impact To Patient 350 350
No Patient Involvement 119 119
Chemical Exposure 67 67
No Information 47 47
Blood Loss 35 35
Low Blood Pressure/ Hypotension 28 28
High Blood Pressure/ Hypertension 9 9
Missed Dose 5 5
No Code Available 5 5
Death 5 5
Unspecified Infection 5 5
Nausea 4 4
Bradycardia 4 4
Complaint, Ill-Defined 4 4
Low Oxygen Saturation 4 4
Air Embolism 3 3
Underdose 3 3
Insufficient Information 3 3
Tachycardia 3 3
Patient Problem/Medical Problem 3 3
Hemorrhage/Bleeding 3 3
Hypoglycemia 3 3
Overdose 2 2
Hyperglycemia 2 2
Headache 2 2
Cardiac Arrest 2 2
Apnea 2 2
Loss Of Pulse 2 2
No Clinical Signs, Symptoms or Conditions 2 2
Hypovolemia 2 2
Malaise 1 1
Sedation 1 1
Extubate 1 1
Respiratory Failure 1 1
Skin Tears 1 1
Pulmonary Embolism 1 1
Cardiopulmonary Arrest 1 1
Emotional Changes 1 1
Erythema 1 1
Exsanguination 1 1
Infiltration into Tissue 1 1
Sepsis 1 1
Skin Discoloration 1 1
Vascular System (Circulation), Impaired 1 1
Blister 1 1
Tissue Damage 1 1
Venipuncture 1 1
Burning Sensation 1 1
Cardiogenic Shock 1 1
Injury 1 1
Inadequate Pain Relief 1 1
Low Pulmonary Arterial Wedge Pressure 1 1
Increased Respiratory Rate 1 1
Confusion/ Disorientation 1 1
Bacterial Infection 1 1
Exposure to Body Fluids 1 1
Chest Pain 1 1
Pain 1 1
Phlebitis 1 1
Seizures 1 1
Hypoxia 1 1
Laceration(s) 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Elcam Medical, Inc. II Apr-20-2017
2 ICU Medical de Mexico, S.A. de C.V. II Aug-16-2018
3 ICU Medical, Inc. II May-06-2020
4 ICU Medical, Inc. II Oct-04-2018
5 ICU Medical, Inc. II Aug-07-2018
6 ICU Medical, Inc. II Apr-10-2018
7 ICU Medical, Inc. II Nov-17-2017
8 ICU Medical, Inc. II Jun-26-2017
9 ICU Medical, Inc. II Jan-10-2017
10 ICU Medical, Inc. II May-07-2015
11 Smiths Medical ASD Inc. II Jul-05-2019
12 Value Plastics, Inc. II Mar-09-2016
13 Vygon MFG, Inc., dba/ Churchill Medical Systems, Inc. II Feb-21-2018
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