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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 CORP.
  SUBSTANTIALLY EQUIVALENT 1
BAXTER HEALTHCARE CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
DYNAREX CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
ELCAM MEDICAL A.C.A.L.
  SUBSTANTIALLY EQUIVALENT 1
ELCAM MEDICAL ACAL
  SUBSTANTIALLY EQUIVALENT 3
ICU MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
M/S ROMSONS INTERNATIONAL
  SUBSTANTIALLY EQUIVALENT 1
MONUMEDICAL, LLC
  SUBSTANTIALLY EQUIVALENT 1
SURGIN SURGICAL INSTRUMENTATION, INC.
  SUBSTANTIALLY EQUIVALENT 1
YOMURA TECHNOLOGIES INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2014 105 105
2015 96 96
2016 148 148
2017 114 114
2018 164 166
2019 400 414
2020 284 284
2021 245 245
2022 280 280
2023 690 690
2024 178 178

Device Problems MDRs with this Device Problem Events in those MDRs
Fluid/Blood Leak 923 939
Leak/Splash 526 526
Disconnection 282 284
Crack 171 171
Break 151 151
Device Contamination with Chemical or Other Material 134 134
No Flow 123 123
Air/Gas in Device 84 84
Connection Problem 81 81
Loose or Intermittent Connection 70 70
Detachment of Device or Device Component 59 59
Material Separation 56 56
Particulates 49 49
Infusion or Flow Problem 49 49
Failure to Prime 36 36
Backflow 29 29
Detachment Of Device Component 29 29
Device Operates Differently Than Expected 21 21
Obstruction of Flow 19 19
Defective Component 17 17
Fracture 16 16
Insufficient Information 16 16
Packaging Problem 15 15
Gas/Air Leak 14 14
Separation Problem 14 14
Complete Blockage 14 14
Contamination 13 13
Device Damaged Prior to Use 13 13
Physical Resistance/Sticking 13 13
Adverse Event Without Identified Device or Use Problem 13 13
Material Twisted/Bent 11 11
Excess Flow or Over-Infusion 11 11
Air Leak 11 11
Mechanical Problem 10 10
Free or Unrestricted Flow 10 10
Defective Device 10 10
Improper Flow or Infusion 9 9
Material Deformation 9 9
Material Split, Cut or Torn 9 9
Disassembly 9 9
Material Puncture/Hole 8 8
Failure to Disconnect 8 8
Device Dislodged or Dislocated 8 8
Device Markings/Labelling Problem 8 8
Contamination /Decontamination Problem 7 7
Separation Failure 7 7
Insufficient Flow or Under Infusion 7 7
Hole In Material 7 7
Delivered as Unsterile Product 7 7
Filling Problem 6 6
Kinked 6 6
Improper or Incorrect Procedure or Method 6 6
Inaccurate Delivery 6 6
Incomplete or Inadequate Connection 6 6
Blocked Connection 5 5
Unsealed Device Packaging 5 5
Reflux within Device 5 5
Component(s), broken 5 5
Partial Blockage 5 5
Bent 4 4
Inaccurate Flow Rate 4 4
Flushing Problem 4 4
Retraction Problem 4 4
Device Inoperable 4 4
Failure to Infuse 4 4
Component Missing 4 4
Failure to Deliver 4 4
Microbial Contamination of Device 3 3
Burst Container or Vessel 3 3
Material Protrusion/Extrusion 3 3
Mechanical Jam 3 3
Inaccurate Information 3 3
Component Misassembled 2 2
Device Fell 2 2
Material Integrity Problem 2 2
Physical Property Issue 2 2
Protective Measures Problem 2 2
Device Packaging Compromised 2 2
Component Falling 2 2
Tear, Rip or Hole in Device Packaging 2 2
Split 2 2
Dent in Material 2 2
Precipitate in Device or Device Ingredient 2 2
Increase in Pressure 1 1
Sticking 1 1
Use of Device Problem 1 1
Suction Problem 1 1
Material Rupture 1 1
Expiration Date Error 1 1
Structural Problem 1 1
Physical Resistance 1 1
Fungus in Device Environment 1 1
Material Discolored 1 1
Loss of or Failure to Bond 1 1
Defective Alarm 1 1
No Audible Alarm 1 1
Alarm Not Visible 1 1
Material Fragmentation 1 1
Unintended Ejection 1 1
Difficult to Flush 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 1193 1193
No Known Impact Or Consequence To Patient 514 518
No Consequences Or Impact To Patient 493 505
No Patient Involvement 138 138
Chemical Exposure 133 133
Low Blood Pressure/ Hypotension 80 80
Insufficient Information 71 71
No Information 48 48
Blood Loss 37 37
Fever 31 31
Swelling 31 31
Hemorrhage/Bleeding 21 21
Phlebitis 18 18
High Blood Pressure/ Hypertension 11 11
Air Embolism 11 11
Cardiac Arrest 7 7
Unspecified Infection 6 6
Thrombus 6 6
Tachycardia 5 5
Missed Dose 5 5
Low Oxygen Saturation 5 5
Death 5 5
Awareness during Anaesthesia 5 5
No Code Available 5 5
Exposure to Body Fluids 4 4
Nausea 4 4
Hypoglycemia 4 4
Complaint, Ill-Defined 4 4
Underdose 4 4
Sepsis 4 4
Bradycardia 4 4
Patient Problem/Medical Problem 3 3
Loss of consciousness 3 3
Discomfort 2 2
Loss Of Pulse 2 2
Burning Sensation 2 2
Hypovolemia 2 2
Malaise 2 2
Sedation 2 2
Skin Discoloration 2 2
Hypoxia 2 2
Hyperglycemia 2 2
Headache 2 2
Overdose 2 2
Pain 2 2
Inflammation 2 2
Apnea 2 2
Bacterial Infection 2 2
Emotional Changes 2 2
Cardiopulmonary Arrest 2 2
Stroke/CVA 2 2
Skin Burning Sensation 2 2
Unintended Radiation Exposure 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Embolism/Embolus 1 1
Thrombosis/Thrombus 1 1
Blister 1 1
Chest Pain 1 1
Erythema 1 1
Exsanguination 1 1
Erosion 1 1
Pulmonary Embolism 1 1
Radiation Overdose 1 1
Laceration(s) 1 1
Infiltration into Tissue 1 1
Respiratory Distress 1 1
Seizures 1 1
Hypersensitivity/Allergic reaction 1 1
Tissue Damage 1 1
Under no medication 1 1
Venipuncture 1 1
Ventricular Fibrillation 1 1
Inadequate Pain Relief 1 1
Ventilator Dependent 1 1
Extubate 1 1
Cardiogenic Shock 1 1
Confusion/ Disorientation 1 1
Vascular System (Circulation), Impaired 1 1
Injury 1 1
Low Pulmonary Arterial Wedge Pressure 1 1
Respiratory Failure 1 1
Increased Respiratory Rate 1 1
Skin Tears 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Baxter Healthcare Corp. II Jan-11-2012
2 Baxter Healthcare Corp. II Jun-22-2011
3 Baxter Healthcare Corp. II Dec-09-2010
4 Becton Dickinson & Company II Jul-21-2022
5 Elcam Medical, Inc. II Apr-20-2017
6 ICU Medical de Mexico, S.A. de C.V. II Aug-16-2018
7 ICU Medical, Inc. II Sep-09-2022
8 ICU Medical, Inc. II Feb-05-2021
9 ICU Medical, Inc. II Dec-01-2020
10 ICU Medical, Inc. II May-06-2020
11 ICU Medical, Inc. II Oct-04-2018
12 ICU Medical, Inc. II Aug-07-2018
13 ICU Medical, Inc. II Apr-10-2018
14 ICU Medical, Inc. II Nov-17-2017
15 ICU Medical, Inc. II Jun-26-2017
16 ICU Medical, Inc. II Jan-10-2017
17 ICU Medical, Inc. II May-07-2015
18 ICU Medical, Inc. I Sep-19-2014
19 ICU Medical, Inc. II Aug-02-2012
20 Smiths Medical ASD Inc. II Oct-20-2021
21 Smiths Medical ASD Inc. II Jul-05-2019
22 Value Plastics, Inc. II Mar-09-2016
23 Vygon MFG, Inc., dba/ Churchill Medical Systems, Inc. II Feb-21-2018
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