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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
Product CodeFMG
Regulation Number 880.5440
Device Class 2


Premarket Reviews
ManufacturerDecision
DYNAREX CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
ELCAM MEDICAL ACAL
  SUBSTANTIALLY EQUIVALENT 2
MONUMEDICAL, LLC
  SUBSTANTIALLY EQUIVALENT 1
YOMURA TECHNOLOGIES INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2017 114 114
2018 164 166
2019 400 414
2020 284 284
2021 245 245
2022 176 176

Device Problems MDRs with this Device Problem Events in those MDRs
Fluid Leak 458 474
Leak/Splash 435 435
Disconnection 108 110
Crack 86 86
Device Contamination with Chemical or Other Material 86 86
Break 70 70
Loose or Intermittent Connection 42 42
Infusion or Flow Problem 38 38
Connection Problem 29 29
Detachment of Device or Device Component 27 27
Air/Gas in Device 25 25
Material Separation 16 16
No Flow 14 14
Gas Leak 13 13
Complete Blockage 13 13
Backflow 11 11
Obstruction of Flow 11 11
Defective Component 10 10
Particulates 10 10
Packaging Problem 9 9
Material Twisted/Bent 8 8
Mechanical Problem 8 8
Free or Unrestricted Flow 8 8
Device Operates Differently Than Expected 7 7
Delivered as Unsterile Product 7 7
Excess Flow or Over-Infusion 7 7
Improper Flow or Infusion 7 7
Contamination /Decontamination Problem 6 6
Defective Device 6 6
Inaccurate Delivery 5 5
Unsealed Device Packaging 5 5
Physical Resistance/Sticking 5 5
Material Split, Cut or Torn 4 4
Failure to Prime 4 4
Detachment Of Device Component 4 4
Flushing Problem 4 4
Reflux within Device 3 3
Insufficient Flow or Under Infusion 3 3
Device Markings/Labelling Problem 3 3
Failure to Disconnect 3 3
Incomplete or Inadequate Connection 3 3
Separation Problem 3 3
Material Protrusion/Extrusion 3 3
Adverse Event Without Identified Device or Use Problem 3 3
Mechanical Jam 2 2
Device Fell 2 2
Physical Property Issue 2 2
Protective Measures Problem 2 2
Device Damaged Prior to Use 2 2
Improper or Incorrect Procedure or Method 2 2
Retraction Problem 2 2
Failure to Infuse 2 2
Dent in Material 2 2
Burst Container or Vessel 2 2
Filling Problem 2 2
Material Puncture/Hole 2 2
Kinked 2 2
Increase in Pressure 1 1
Occlusion Within Device 1 1
Material Opacification 1 1
Pacing Problem 1 1
Misassembled 1 1
Unintended Ejection 1 1
Fracture 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
Split 1 1
Structural Problem 1 1
Tear, Rip or Hole in Device Packaging 1 1
Failure to Deliver 1 1
Material Rupture 1 1
Use of Device Problem 1 1
Suction Problem 1 1
Physical Resistance 1 1
Aspiration Issue 1 1
Blocked Connection 1 1
Deformation Due to Compressive Stress 1 1
Device Dislodged or Dislocated 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Material Deformation 1 1
Material Integrity Problem 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
Positioning Problem 1 1
Output Problem 1 1
Illegible Information 1 1
Inaccurate Information 1 1
Missing Information 1 1
Priming 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 304 304
Chemical Exposure 96 96
No Patient Involvement 77 77
Insufficient Information 45 45
No Information 39 39
Low Blood Pressure/ Hypotension 32 32
Blood Loss 30 30
Hemorrhage/Bleeding 11 11
Air Embolism 7 7
Death 5 5
Unspecified Infection 5 5
Complaint, Ill-Defined 4 4
Hypoglycemia 4 4
Cardiac Arrest 4 4
Missed Dose 4 4
Underdose 3 3
Low Oxygen Saturation 3 3
Bradycardia 3 3
High Blood Pressure/ Hypertension 3 3
Nausea 3 3
Tachycardia 3 3
Hypovolemia 2 2
Headache 2 2
Emotional Changes 2 2
Apnea 2 2
Malaise 2 2
No Code Available 2 2
Burning Sensation 2 2
Blister 1 1
Inadequate Pain Relief 1 1
Ventilator Dependent 1 1
Extubate 1 1
Respiratory Failure 1 1
Increased Respiratory Rate 1 1
Skin Tears 1 1
Confusion/ Disorientation 1 1
Loss Of Pulse 1 1
Patient Problem/Medical Problem 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
Erythema 1 1
Exsanguination 1 1
Hyperglycemia 1 1
Cardiogenic Shock 1 1
Injury 1 1
Tissue Damage 1 1
Infiltration into Tissue 1 1
Laceration(s) 1 1
Overdose 1 1
Phlebitis 1 1
Seizures 1 1
Sepsis 1 1
Skin Discoloration 1 1
Hypoxia 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Becton Dickinson & Company II Jul-21-2022
2 Elcam Medical, Inc. II Apr-20-2017
3 ICU Medical de Mexico, S.A. de C.V. II Aug-16-2018
4 ICU Medical, Inc. II Sep-09-2022
5 ICU Medical, Inc. II Feb-05-2021
6 ICU Medical, Inc. II Dec-01-2020
7 ICU Medical, Inc. II May-06-2020
8 ICU Medical, Inc. II Oct-04-2018
9 ICU Medical, Inc. II Aug-07-2018
10 ICU Medical, Inc. II Apr-10-2018
11 ICU Medical, Inc. II Nov-17-2017
12 ICU Medical, Inc. II Jun-26-2017
13 ICU Medical, Inc. II Jan-10-2017
14 Smiths Medical ASD Inc. II Oct-20-2021
15 Smiths Medical ASD Inc. II Jul-05-2019
16 Vygon MFG, Inc., dba/ Churchill Medical Systems, Inc. II Feb-21-2018
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