Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search show TPLC since Back to Search Results
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 178 178

Device Problems MDRs with this Device Problem Events in those MDRs
Fluid/Blood Leak 756 770
Leak/Splash 440 440
Disconnection 195 197
Crack 133 133
Device Contamination with Chemical or Other Material 118 118
No Flow 112 112
Break 107 107
Air/Gas in Device 84 84
Loose or Intermittent Connection 57 57
Particulates 49 49
Material Separation 49 49
Connection Problem 47 47
Detachment of Device or Device Component 46 46
Infusion or Flow Problem 43 43
Backflow 27 27
Obstruction of Flow 19 19
Defective Component 16 16
Packaging Problem 14 14
Separation Problem 14 14
Gas/Air Leak 13 13
Complete Blockage 13 13
Contamination 12 12
Physical Resistance/Sticking 12 12
Fracture 11 11
Material Twisted/Bent 11 11
Free or Unrestricted Flow 10 10
Excess Flow or Over-Infusion 10 10
Device Markings/Labelling Problem 8 8
Defective Device 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
Contamination /Decontamination Problem 6 6
Material Deformation 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
Insufficient Flow or Under Infusion 3 3
Device Damaged Prior to Use 3 3
Microbial Contamination of Device 3 3
Component Missing 3 3
Failure to Disconnect 3 3
Material Protrusion/Extrusion 3 3
Mechanical Jam 3 3
Burst Container or Vessel 3 3
Inaccurate Information 3 3
Component Misassembled 2 2
Insufficient Information 2 2
Filling Problem 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
Blocked Connection 1 1
Fungus in Device Environment 1 1
Device Contaminated During Manufacture or Shipping 1 1
Device Dislodged or Dislocated 1 1
Increase in Pressure 1 1
Reflux within Device 1 1
Material Rupture 1 1
Suction Problem 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
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
Device Fell 1 1
Priming Problem 1 1
Illegible Information 1 1
Missing Information 1 1
Wrong Label 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 1193 1193
No Consequences Or Impact To Patient 326 336
No Known Impact Or Consequence To Patient 253 257
Chemical Exposure 119 119
No Patient Involvement 71 71
Insufficient Information 71 71
Low Blood Pressure/ Hypotension 61 61
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
Hypoglycemia 4 4
Sepsis 4 4
Tachycardia 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
-
-