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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
BAXTER HEALTHCARE CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
ELCAM MEDICAL ACAL
  SUBSTANTIALLY EQUIVALENT 2
M/S ROMSONS INTERNATIONAL
  SUBSTANTIALLY EQUIVALENT 1
MONUMEDICAL, LLC
  SUBSTANTIALLY EQUIVALENT 1
YOMURA TECHNOLOGIES INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 400 414
2020 284 284
2021 245 245
2022 280 280
2023 690 690
2024 470 470

Device Problems MDRs with this Device Problem Events in those MDRs
Fluid/Blood Leak 915 929
Leak/Splash 470 470
Disconnection 213 215
Crack 160 160
No Flow 131 131
Device Contamination with Chemical or Other Material 120 120
Break 110 110
Air/Gas in Device 87 87
Material Separation 63 63
Loose or Intermittent Connection 59 59
Particulates 49 49
Connection Problem 48 48
Detachment of Device or Device Component 46 46
Infusion or Flow Problem 45 45
Backflow 31 31
Separation Problem 22 22
Defective Component 20 20
Obstruction of Flow 20 20
Fitting Problem 14 14
Difficult to Open or Close 14 14
Packaging Problem 14 14
Gas/Air Leak 13 13
Complete Blockage 13 13
Contamination 12 12
Physical Resistance/Sticking 12 12
Material Twisted/Bent 11 11
Fracture 11 11
Free or Unrestricted Flow 11 11
Excess Flow or Over-Infusion 10 10
Device Markings/Labelling Problem 8 8
Separation Failure 8 8
Defective Device 8 8
Material Split, Cut or Torn 8 8
Incomplete or Inadequate Connection 7 7
Inaccurate Delivery 7 7
Mechanical Problem 7 7
Delivered as Unsterile Product 7 7
Material Puncture/Hole 7 7
Contamination /Decontamination Problem 6 6
Material Deformation 6 6
Improper Flow or Infusion 5 5
Unsealed Device Packaging 5 5
Failure to Prime 4 4
Inaccurate Flow Rate 4 4
Flushing Problem 4 4
Failure to Deliver 4 4
Retraction Problem 4 4
Microbial Contamination of Device 3 3
Component Missing 3 3
Insufficient Flow or Under Infusion 3 3
Device Damaged Prior to Use 3 3
Material Integrity Problem 3 3
Material Protrusion/Extrusion 3 3
Failure to Disconnect 3 3
Burst Container or Vessel 3 3
Mechanical Jam 3 3
Inaccurate Information 3 3
Component Misassembled 2 2
Insufficient Information 2 2
Filling Problem 2 2
Difficult to Remove 2 2
Precipitate in Device or Device Ingredient 2 2
Dent in Material 2 2
Material Rupture 2 2
Suction Problem 1 1
Fungus in Device Environment 1 1
Expiration Date Error 1 1
Failure to Infuse 1 1
Tear, Rip or Hole in Device Packaging 1 1
Blocked Connection 1 1
Difficult to Open or Remove Packaging Material 1 1
Device Dislodged or Dislocated 1 1
Device Contaminated During Manufacture or Shipping 1 1
Premature Activation 1 1
Increase in Pressure 1 1
Reflux within Device 1 1
Material Fragmentation 1 1
Material Opacification 1 1
Pacing Problem 1 1
Material Discolored 1 1
Difficult to Flush 1 1
Partial Blockage 1 1
Loss of or Failure to Bond 1 1
Defective Alarm 1 1
No Audible Alarm 1 1
Alarm Not Visible 1 1
Appropriate Term/Code Not Available 1 1
Priming Problem 1 1
Device Fell 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Output Problem 1 1
Positioning Problem 1 1
Protective Measures Problem 1 1
Temperature Problem 1 1
Unintended Movement 1 1
Missing Information 1 1
Illegible Information 1 1
Wrong Label 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 1471 1471
No Consequences Or Impact To Patient 326 336
No Known Impact Or Consequence To Patient 253 257
Chemical Exposure 124 124
Insufficient Information 77 77
No Patient Involvement 71 71
Low Blood Pressure/ Hypotension 66 66
No Information 31 31
Hemorrhage/Bleeding 23 23
Blood Loss 19 19
High Blood Pressure/ Hypertension 8 8
Air Embolism 8 8
Awareness during Anaesthesia 5 5
Cardiac Arrest 5 5
Death 5 5
Sepsis 5 5
Tachycardia 4 4
Hypoglycemia 4 4
Low Oxygen Saturation 4 4
Nausea 3 3
Headache 2 2
Burning Sensation 2 2
Discomfort 2 2
Emotional Changes 2 2
Exposure to Body Fluids 2 2
Stroke/CVA 2 2
Underdose 2 2
Missed Dose 2 2
Malaise 2 2
Skin Burning Sensation 2 2
Loss of consciousness 2 2
Unintended Radiation Exposure 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Inadequate Pain Relief 1 1
Ventilator Dependent 1 1
Extubate 1 1
Loss Of Pulse 1 1
Respiratory Failure 1 1
Increased Respiratory Rate 1 1
Patient Problem/Medical Problem 1 1
No Code Available 1 1
Embolism/Embolus 1 1
Thrombosis/Thrombus 1 1
Blister 1 1
Cardiopulmonary Arrest 1 1
Bacterial Infection 1 1
Pulmonary Embolism 1 1
Radiation Overdose 1 1
Erythema 1 1
Extreme Exhaustion 1 1
Hyperglycemia 1 1
Hypersensitivity/Allergic reaction 1 1
Complaint, Ill-Defined 1 1
Injury 1 1
Cardiogenic Shock 1 1
Overdose 1 1
Tissue Damage 1 1
Ventricular Fibrillation 1 1
Hypoxia 1 1
Unspecified Infection 1 1
Infiltration into Tissue 1 1
Laceration(s) 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Becton Dickinson & Company II Jul-21-2022
2 ICU Medical, Inc. II Sep-09-2022
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 Smiths Medical ASD Inc. II Oct-20-2021
7 Smiths Medical ASD Inc. II Jul-05-2019
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