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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 276 276

Device Problems MDRs with this Device Problem Events in those MDRs
Fluid/Blood Leak 815 829
Leak/Splash 447 447
Disconnection 206 208
Crack 139 139
Device Contamination with Chemical or Other Material 119 119
No Flow 117 117
Break 109 109
Air/Gas in Device 84 84
Loose or Intermittent Connection 58 58
Material Separation 53 53
Particulates 49 49
Connection Problem 47 47
Detachment of Device or Device Component 46 46
Infusion or Flow Problem 44 44
Backflow 28 28
Defective Component 19 19
Obstruction of Flow 19 19
Separation Problem 17 17
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
Defective Device 8 8
Device Markings/Labelling Problem 8 8
Material Split, Cut or Torn 8 8
Separation Failure 7 7
Mechanical Problem 7 7
Delivered as Unsterile Product 7 7
Material Puncture/Hole 6 6
Inaccurate Delivery 6 6
Material Deformation 6 6
Contamination /Decontamination Problem 6 6
Incomplete or Inadequate Connection 6 6
Improper Flow or Infusion 5 5
Unsealed Device Packaging 5 5
Retraction Problem 4 4
Inaccurate Flow Rate 4 4
Flushing Problem 4 4
Failure to Prime 4 4
Failure to Deliver 4 4
Failure to Disconnect 3 3
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 Protrusion/Extrusion 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
Material Rupture 2 2
Precipitate in Device or Device Ingredient 2 2
Material Integrity Problem 2 2
Dent in Material 2 2
Expiration Date Error 1 1
Failure to Infuse 1 1
Tear, Rip or Hole in Device Packaging 1 1
Suction Problem 1 1
Fungus in Device Environment 1 1
Device Contaminated During Manufacture or Shipping 1 1
Difficult to Open or Remove Packaging Material 1 1
Device Dislodged or Dislocated 1 1
Blocked Connection 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 1290 1290
No Consequences Or Impact To Patient 326 336
No Known Impact Or Consequence To Patient 253 257
Chemical Exposure 122 122
No Patient Involvement 71 71
Insufficient Information 71 71
Low Blood Pressure/ Hypotension 62 62
No Information 31 31
Blood Loss 19 19
Hemorrhage/Bleeding 19 19
Air Embolism 8 8
Awareness during Anaesthesia 5 5
Cardiac Arrest 5 5
Death 5 5
High Blood Pressure/ Hypertension 5 5
Sepsis 5 5
Tachycardia 4 4
Hypoglycemia 4 4
Nausea 3 3
Low Oxygen Saturation 3 3
Discomfort 2 2
Underdose 2 2
Missed Dose 2 2
Skin Burning Sensation 2 2
Loss of consciousness 2 2
Headache 2 2
Burning Sensation 2 2
Malaise 2 2
Emotional Changes 2 2
Exposure to Body Fluids 2 2
Stroke/CVA 2 2
Cardiopulmonary Arrest 1 1
Bacterial Infection 1 1
Pulmonary Embolism 1 1
Radiation Overdose 1 1
Erythema 1 1
Hyperglycemia 1 1
Hypersensitivity/Allergic reaction 1 1
Hypoxia 1 1
Unspecified Infection 1 1
Infiltration into Tissue 1 1
Laceration(s) 1 1
Inadequate Pain Relief 1 1
Ventilator Dependent 1 1
Extubate 1 1
Cardiogenic Shock 1 1
Overdose 1 1
Tissue Damage 1 1
Ventricular Fibrillation 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Unintended Radiation Exposure 1 1
Patient Problem/Medical Problem 1 1
No Code Available 1 1
Embolism/Embolus 1 1
Thrombosis/Thrombus 1 1
Blister 1 1
Loss Of Pulse 1 1
Complaint, Ill-Defined 1 1
Injury 1 1
Respiratory Failure 1 1
Increased Respiratory Rate 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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