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

MDR Year MDR Reports MDR Events
2021 245 251
2022 280 283
2023 689 690
2024 935 938
2025 877 877
2026 44 44

Device Problems MDRs with this Device Problem Events in those MDRs
Fluid/Blood Leak 1382 1392
Leak/Splash 348 349
Disconnection 275 275
Crack 248 248
No Flow 237 239
Break 163 163
Material Separation 144 144
Air/Gas in Device 114 115
Device Contamination with Chemical or Other Material 100 101
Particulates 57 57
Separation Problem 54 54
Connection Problem 51 51
Loose or Intermittent Connection 46 46
Detachment of Device or Device Component 42 42
Defective Component 37 37
Backflow 35 35
Contamination 30 30
Infusion or Flow Problem 30 30
Material Split, Cut or Torn 26 26
Obstruction of Flow 24 24
Fracture 19 19
Complete Blockage 16 16
Difficult to Open or Close 15 15
Fitting Problem 15 15
Material Puncture/Hole 12 12
Physical Resistance/Sticking 10 10
Packaging Problem 10 10
Insufficient Flow or Under Infusion 9 9
Contamination /Decontamination Problem 9 9
Separation Failure 8 8
Free or Unrestricted Flow 8 8
Material Deformation 8 8
Incomplete or Inadequate Connection 7 7
Unsealed Device Packaging 7 7
Material Integrity Problem 7 7
Material Rupture 7 7
Delivered as Unsterile Product 7 7
Component Missing 7 7
Inaccurate Delivery 6 6
Device Markings/Labelling Problem 6 6
Mechanical Jam 6 6
Defective Device 6 6
Material Twisted/Bent 6 6
Excess Flow or Over-Infusion 5 5
Inaccurate Flow Rate 5 5
Failure to Infuse 4 4
Improper Flow or Infusion 4 4
Mechanical Problem 4 4
Difficult to Remove 4 4
Gas/Air Leak 3 3

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 2704 2709
Insufficient Information 116 123
Chemical Exposure 88 88
Low Blood Pressure/ Hypotension 83 84
No Consequences Or Impact To Patient 71 71
Hemorrhage/Bleeding 61 61
High Blood Pressure/ Hypertension 9 9
Air Embolism 8 8
Hypoglycemia 7 7
Awareness during Anaesthesia 7 7
Irritability 6 6
Sepsis 6 6
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 5 5
Cardiac Arrest 5 5
Tachycardia 5 5
Exposure to Body Fluids 5 5
Low Oxygen Saturation 4 4
Ventricular Fibrillation 3 3
Skin Burning Sensation 2 2
Ventilator Dependent 2 2
Bacterial Infection 2 2
Loss of consciousness 2 2
Anxiety 2 2
Discomfort 2 2
No Patient Involvement 2 2
Hypersensitivity/Allergic reaction 2 2
Stroke/CVA 2 2
Pain 1 1
Fluid Discharge 1 1
Thrombosis/Thrombus 1 1
Shaking/Tremors 1 1
Burning Sensation 1 1
Hypoxia 1 1
Convulsion/Seizure 1 1
Blood Loss 1 1
Embolism/Embolus 1 1
Malaise 1 1
Diaphoresis 1 1
Emotional Changes 1 1
Respiratory Insufficiency 1 1
Weight Changes 1 1
Unintended Radiation Exposure 1 1
Extreme Exhaustion 1 1

Recalls
Manufacturer Recall Class Date Posted
1 B Braun Medical Inc II Nov-26-2025
2 BD SWITZERLAND SARL II Apr-02-2025
3 Baxter Healthcare Corporation II Oct-16-2025
4 Becton Dickinson & Company II Jul-21-2022
5 ICU Medical, Inc. I Oct-23-2025
6 ICU Medical, Inc. II Sep-09-2022
7 ICU Medical, Inc. II Feb-05-2021
8 Smiths Medical ASD Inc. II Oct-20-2021
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