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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
DYNAREX 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
2018 164 166
2019 400 414
2020 284 284
2021 245 245
2022 280 280
2023 390 390

Device Problems MDRs with this Device Problem Events in those MDRs
Fluid/Blood Leak 620 636
Leak/Splash 452 452
Disconnection 165 167
Crack 111 111
Device Contamination with Chemical or Other Material 107 107
Break 93 93
Loose or Intermittent Connection 55 55
Air/Gas in Device 52 52
Connection Problem 51 51
No Flow 45 45
Particulates 43 43
Infusion or Flow Problem 40 40
Detachment of Device or Device Component 38 38
Material Separation 26 26
Backflow 23 23
Obstruction of Flow 16 16
Defective Component 14 14
Gas/Air Leak 13 13
Packaging Problem 13 13
Physical Resistance/Sticking 13 13
Complete Blockage 12 12
Contamination 10 10
Fracture 9 9
Material Twisted/Bent 9 9
Defective Device 9 9
Free or Unrestricted Flow 8 8
Improper Flow or Infusion 7 7
Contamination /Decontamination Problem 7 7
Excess Flow or Over-Infusion 7 7
Mechanical Problem 7 7
Delivered as Unsterile Product 7 7
Device Markings/Labelling Problem 6 6
Inaccurate Delivery 6 6
Material Split, Cut or Torn 6 6
Separation Problem 5 5
Unsealed Device Packaging 5 5
Failure to Deliver 4 4
Insufficient Flow or Under Infusion 4 4
Retraction Problem 4 4
Failure to Prime 4 4
Inaccurate Flow Rate 4 4
Flushing Problem 4 4
Incomplete or Inadequate Connection 4 4
Detachment Of Device Component 3 3
Material Puncture/Hole 3 3
Device Damaged Prior to Use 3 3
Failure to Disconnect 3 3
Material Protrusion/Extrusion 3 3
Mechanical Jam 3 3
Material Deformation 3 3
Material Integrity Problem 2 2
Separation Failure 2 2
Dent in Material 2 2
Microbial Contamination of Device 2 2
Reflux within Device 2 2
Improper or Incorrect Procedure or Method 2 2
Burst Container or Vessel 2 2
Filling Problem 2 2
Device Fell 2 2
Protective Measures Problem 2 2
Insufficient Information 2 2
Appropriate Term/Code Not Available 1 1
Component Misassembled 1 1
Temperature Problem 1 1
Unintended Movement 1 1
Positioning Problem 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Output Problem 1 1
Priming Problem 1 1
Illegible Information 1 1
Inaccurate Information 1 1
Missing Information 1 1
Wrong Label 1 1
Unintended Ejection 1 1
Material Discolored 1 1
Component Falling 1 1
Partial Blockage 1 1
Loss of or Failure to Bond 1 1
Air Leak 1 1
Defective Alarm 1 1
Suction Problem 1 1
Material Rupture 1 1
Increase in Pressure 1 1
Occlusion Within Device 1 1
Material Opacification 1 1
Pacing Problem 1 1
Kinked 1 1
Material Fragmentation 1 1
Component Missing 1 1
Failure to Infuse 1 1
Tear, Rip or Hole in Device Packaging 1 1
Expiration Date Error 1 1
Structural Problem 1 1
Blocked Connection 1 1
Deformation Due to Compressive Stress 1 1
Device Contaminated During Manufacture or Shipping 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 738 738
No Consequences Or Impact To Patient 368 380
No Known Impact Or Consequence To Patient 347 351
Chemical Exposure 120 120
No Patient Involvement 75 75
Insufficient Information 64 64
Low Blood Pressure/ Hypotension 56 56
No Information 38 38
Blood Loss 25 25
Hemorrhage/Bleeding 15 15
Air Embolism 8 8
Cardiac Arrest 7 7
Awareness during Anaesthesia 5 5
Death 5 5
Hypoglycemia 4 4
Missed Dose 4 4
Low Oxygen Saturation 3 3
High Blood Pressure/ Hypertension 3 3
Nausea 3 3
Sepsis 3 3
Tachycardia 2 2
Hypovolemia 2 2
Malaise 2 2
Unspecified Infection 2 2
Emotional Changes 2 2
Stroke/CVA 2 2
Headache 2 2
Exposure to Body Fluids 2 2
Underdose 2 2
Discomfort 2 2
Burning Sensation 2 2
Loss of consciousness 2 2
No Code Available 2 2
Skin Burning Sensation 2 2
Unintended Radiation Exposure 1 1
Patient Problem/Medical Problem 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not 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
Confusion/ Disorientation 1 1
Respiratory Failure 1 1
Increased Respiratory Rate 1 1
Bradycardia 1 1
Cardiopulmonary Arrest 1 1
Pulmonary Embolism 1 1
Radiation Overdose 1 1
Hyperglycemia 1 1
Erythema 1 1
Exsanguination 1 1
Infiltration into Tissue 1 1
Laceration(s) 1 1
Overdose 1 1
Phlebitis 1 1
Hypoxia 1 1
Inadequate Pain Relief 1 1
Ventilator Dependent 1 1
Extubate 1 1
Cardiogenic Shock 1 1
Tissue Damage 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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