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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 CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
ELCAM MEDICAL ACAL
  SUBSTANTIALLY EQUIVALENT 1
MONUMEDICAL, LLC
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2017 114 114
2018 164 166
2019 400 414
2020 284 284
2021 245 245

Device Problems MDRs with this Device Problem Events in those MDRs
Fluid Leak 399 415
Leak/Splash 393 393
Disconnection 94 96
Crack 78 78
Device Contamination with Chemical or Other Material 78 78
Break 61 61
Loose or Intermittent Connection 37 37
Infusion or Flow Problem 34 34
Connection Problem 28 28
Detachment of Device or Device Component 20 20
Material Separation 13 13
No Flow 13 13
Gas Leak 12 12
Complete Blockage 12 12
Backflow 11 11
Particulates 10 10
Packaging Problem 9 9
Air/Gas in Device 9 9
Material Twisted/Bent 8 8
Mechanical Problem 8 8
Delivered as Unsterile Product 7 7
Excess Flow or Over-Infusion 7 7
Device Operates Differently Than Expected 7 7
Defective Component 7 7
Defective Device 6 6
Improper Flow or Infusion 6 6
Contamination /Decontamination Problem 6 6
Free or Unrestricted Flow 5 5
Flushing Problem 4 4
Detachment Of Device Component 4 4
Unsealed Device Packaging 4 4
Failure to Prime 4 4
Material Split, Cut or Torn 4 4
Physical Resistance/Sticking 4 4
Material Protrusion/Extrusion 3 3
Adverse Event Without Identified Device or Use Problem 3 3
Reflux within Device 3 3
Device Markings/Labelling Problem 3 3
Obstruction of Flow 3 3
Failure to Disconnect 3 3
Dent in Material 2 2
Failure to Infuse 2 2
Insufficient Flow or Under Infusion 2 2
Device Damaged Prior to Use 2 2
Improper or Incorrect Procedure or Method 2 2
Retraction Problem 2 2
Material Puncture/Hole 2 2
Kinked 2 2
Burst Container or Vessel 2 2
Filling Problem 2 2
Protective Measures Problem 2 2
Device Fell 2 2
Incomplete or Inadequate Connection 2 2
Separation Problem 2 2
Physical Property Issue 2 2
Positioning Problem 1 1
Illegible Information 1 1
Temperature Problem 1 1
Unintended Movement 1 1
Insufficient Information 1 1
Appropriate Term/Code Not Available 1 1
Component Misassembled 1 1
Unintended Ejection 1 1
Material Fragmentation 1 1
Component Falling 1 1
Contamination 1 1
Loss of or Failure to Bond 1 1
Air Leak 1 1
Defective Alarm 1 1
Increase in Pressure 1 1
Occlusion Within Device 1 1
Material Opacification 1 1
Pacing Problem 1 1
Misassembled 1 1
Suction Problem 1 1
Use of Device Problem 1 1
Failure to Deliver 1 1
Inaccurate Delivery 1 1
Tear, Rip or Hole in Device Packaging 1 1
Structural Problem 1 1
Split 1 1
Physical Resistance 1 1
Device Dislodged or Dislocated 1 1
Aspiration Issue 1 1
Blocked Connection 1 1
Deformation Due to Compressive Stress 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Material Deformation 1 1
Material Integrity Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 405 417
No Known Impact Or Consequence To Patient 399 403
No Clinical Signs, Symptoms or Conditions 150 150
Chemical Exposure 85 85
No Patient Involvement 77 77
No Information 39 39
Insufficient Information 34 34
Blood Loss 30 30
Low Blood Pressure/ Hypotension 28 28
Hemorrhage/Bleeding 9 9
Death 5 5
Unspecified Infection 5 5
Complaint, Ill-Defined 4 4
Missed Dose 4 4
Underdose 3 3
Low Oxygen Saturation 3 3
Tachycardia 3 3
Nausea 3 3
High Blood Pressure/ Hypertension 3 3
Hypoglycemia 3 3
Air Embolism 3 3
Bradycardia 3 3
Cardiac Arrest 2 2
Apnea 2 2
Emotional Changes 2 2
Headache 2 2
Burning Sensation 2 2
Hypovolemia 2 2
No Code Available 2 2
Blister 1 1
Loss Of Pulse 1 1
Cardiogenic Shock 1 1
Confusion/ Disorientation 1 1
Respiratory Failure 1 1
Increased Respiratory Rate 1 1
Skin Tears 1 1
Patient Problem/Medical Problem 1 1
Tissue Damage 1 1
Injury 1 1
Malaise 1 1
Inadequate Pain Relief 1 1
Extubate 1 1
Overdose 1 1
Phlebitis 1 1
Seizures 1 1
Sepsis 1 1
Skin Discoloration 1 1
Infiltration into Tissue 1 1
Laceration(s) 1 1
Hypoxia 1 1
Erythema 1 1
Exsanguination 1 1
Hyperglycemia 1 1
Bacterial Infection 1 1
Exposure to Body Fluids 1 1
Cardiopulmonary Arrest 1 1
Awareness during Anaesthesia 1 1
Pulmonary Embolism 1 1
Radiation Overdose 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 Feb-05-2021
4 ICU Medical, Inc. II Dec-01-2020
5 ICU Medical, Inc. II May-06-2020
6 ICU Medical, Inc. II Oct-04-2018
7 ICU Medical, Inc. II Aug-07-2018
8 ICU Medical, Inc. II Apr-10-2018
9 ICU Medical, Inc. II Nov-17-2017
10 ICU Medical, Inc. II Jun-26-2017
11 ICU Medical, Inc. II Jan-10-2017
12 Smiths Medical ASD Inc. II Oct-20-2021
13 Smiths Medical ASD Inc. II Jul-05-2019
14 Vygon MFG, Inc., dba/ Churchill Medical Systems, Inc. II Feb-21-2018
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