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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
2018 164 166
2019 400 414
2020 284 284
2021 245 245
2022 279 279

Device Problems MDRs with this Device Problem Events in those MDRs
Fluid/Blood Leak 460 476
Leak/Splash 424 424
Disconnection 98 100
Crack 90 90
Device Contamination with Chemical or Other Material 86 86
Break 67 67
Loose or Intermittent Connection 44 44
Infusion or Flow Problem 37 37
Detachment of Device or Device Component 34 34
Air/Gas in Device 33 33
Material Separation 20 20
Connection Problem 14 14
Gas/Air Leak 13 13
Obstruction of Flow 13 13
Backflow 13 13
Complete Blockage 12 12
Defective Component 12 12
No Flow 12 12
Packaging Problem 11 11
Particulates 10 10
Defective Device 8 8
Material Twisted/Bent 8 8
Free or Unrestricted Flow 8 8
Contamination /Decontamination Problem 7 7
Improper Flow or Infusion 7 7
Excess Flow or Over-Infusion 7 7
Delivered as Unsterile Product 7 7
Physical Resistance/Sticking 7 7
Mechanical Problem 6 6
Unsealed Device Packaging 5 5
Inaccurate Delivery 5 5
Failure to Prime 4 4
Flushing Problem 4 4
Material Split, Cut or Torn 4 4
Separation Problem 4 4
Material Protrusion/Extrusion 3 3
Incomplete or Inadequate Connection 3 3
Detachment Of Device Component 3 3
Failure to Disconnect 3 3
Insufficient Flow or Under Infusion 3 3
Device Damaged Prior to Use 3 3
Device Markings/Labelling Problem 3 3
Mechanical Jam 2 2
Improper or Incorrect Procedure or Method 2 2
Dent in Material 2 2
Filling Problem 2 2
Material Puncture/Hole 2 2
Reflux within Device 2 2
Retraction Problem 2 2
Burst Container or Vessel 2 2
Device Fell 2 2
Protective Measures Problem 2 2
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
Adverse Event Without Identified Device or Use Problem 1 1
Output Problem 1 1
Illegible Information 1 1
Inaccurate Information 1 1
Missing Information 1 1
Priming Problem 1 1
Kinked 1 1
Occlusion Within Device 1 1
Material Opacification 1 1
Pacing Problem 1 1
Material Rupture 1 1
Unintended Ejection 1 1
Inaccurate Flow Rate 1 1
Fracture 1 1
Material Fragmentation 1 1
Component Falling 1 1
Contamination 1 1
Partial Blockage 1 1
Loss of or Failure to Bond 1 1
Air Leak 1 1
Defective Alarm 1 1
Blocked Connection 1 1
Deformation Due to Compressive Stress 1 1
Failure to Infuse 1 1
Tear, Rip or Hole in Device Packaging 1 1
Structural Problem 1 1
Suction Problem 1 1
Increase in Pressure 1 1
Failure to Deliver 1 1
Device Contaminated During Manufacture or Shipping 1 1
Material Deformation 1 1
Material Integrity Problem 1 1
Device Operates Differently Than Expected 1 1
Device Dislodged or Dislocated 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 391 391
No Consequences Or Impact To Patient 368 380
No Known Impact Or Consequence To Patient 347 351
Chemical Exposure 97 97
No Patient Involvement 75 75
Insufficient Information 48 48
Low Blood Pressure/ Hypotension 39 39
No Information 38 38
Blood Loss 25 25
Hemorrhage/Bleeding 13 13
Air Embolism 6 6
Death 5 5
Missed Dose 4 4
Hypoglycemia 4 4
Cardiac Arrest 4 4
High Blood Pressure/ Hypertension 3 3
Low Oxygen Saturation 3 3
Nausea 3 3
No Code Available 2 2
Awareness during Anaesthesia 2 2
Hypovolemia 2 2
Malaise 2 2
Underdose 2 2
Emotional Changes 2 2
Sepsis 2 2
Headache 2 2
Exposure to Body Fluids 2 2
Tachycardia 2 2
Burning Sensation 2 2
Unspecified Infection 2 2
Laceration(s) 1 1
Blister 1 1
Cardiogenic Shock 1 1
Complaint, Ill-Defined 1 1
Injury 1 1
Ventilator Dependent 1 1
Loss Of Pulse 1 1
Radiation Overdose 1 1
Erythema 1 1
Cardiopulmonary Arrest 1 1
Infiltration into Tissue 1 1
Extubate 1 1
Exsanguination 1 1
Respiratory Failure 1 1
Unintended Radiation Exposure 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Pulmonary Embolism 1 1
Patient Problem/Medical Problem 1 1
Overdose 1 1
Phlebitis 1 1
Tissue Damage 1 1
Inadequate Pain Relief 1 1
Increased Respiratory Rate 1 1
Confusion/ Disorientation 1 1
Bradycardia 1 1
Hyperglycemia 1 1
Hypoxia 1 1

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