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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device set, i.v. fluid transfer
Regulation Description Intravascular administration set.
Product CodeLHI
Regulation Number 880.5440
Device Class 2


Premarket Reviews
ManufacturerDecision
B. BRAUN MEDICAL INC.
  SUBSTANTIALLY EQUIVALENT 2
  1.  K150787  Universal Spike
  2.  K151423  APEX Compounding System Transfer Set
B. BRAUN MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 2
ICU MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
ICU MEDICAL SALES, INC.
  SUBSTANTIALLY EQUIVALENT 1
LABORATORIOS GRIFOLS, S.A.
  SUBSTANTIALLY EQUIVALENT 1
MEDIMOP MEDICAL PROJECTS LTD.
  SUBSTANTIALLY EQUIVALENT 1
SFM MEDICAL DEVICES GMBH
  SUBSTANTIALLY EQUIVALENT 1
YUKON MEDICAL, LLC
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2015 126 126
2016 219 219
2017 533 533
2018 1497 1497
2019 1633 1633
2020 905 905

Device Problems MDRs with this Device Problem Events in those MDRs
Fluid Leak 3283 3283
Port 1543 1543
Device Contamination with Chemical or Other Material 755 755
Bag 288 288
Seal 285 285
Leak/Splash 233 233
Break 116 116
Disconnection 102 102
Adapter (Adaptor) 88 88
Material Puncture/Hole 78 78
Tube 73 73
Connector 73 73
Device Operates Differently Than Expected 70 70
Contamination /Decontamination Problem 58 58
Hole In Material 52 52
Cap 39 39
Clamp 31 31
Difficult to Open or Close 27 27
Infusion or Flow Problem 26 26
Material Rupture 25 25
Insufficient Information 25 25
Chemical Spillage 18 18
Tear, Rip or Hole in Device Packaging 18 18
Detachment of Device or Device Component 18 18
Material Perforation 18 18
Crack 17 17
Improper Flow or Infusion 17 17
Excess Flow or Over-Infusion 16 16
Valve(s) 16 16
Connection Problem 15 15
Loose or Intermittent Connection 14 14
Failure to Align 14 14
Material Separation 13 13
Detachment Of Device Component 13 13
Defective Component 13 13
Material Split, Cut or Torn 13 13
Unsealed Device Packaging 11 11
No Flow 10 10
Delivered as Unsterile Product 10 10
Misassembled 9 9
Device Markings/Labelling Problem 9 9
Defective Device 9 9
Device Packaging Compromised 9 9
Particulates 9 9
Component Missing 9 9
Filling Problem 9 9
Needle 9 9
Cut In Material 8 8
Material Deformation 8 8
Cannula 8 8
Material Integrity Problem 7 7
Device Displays Incorrect Message 7 7
Device Alarm System 7 7
Material Opacification 7 7
Packaging Problem 6 6
Therapeutic or Diagnostic Output Failure 6 6
Complete Blockage 6 6
Fitting Problem 6 6
Device Damaged Prior to Use 5 5
Free or Unrestricted Flow 5 5
Product Quality Problem 5 5
Air Leak 5 5
Inflation Problem 5 5
Manufacturing, Packaging or Shipping Problem 5 5
Failure to Prime 5 5
Device Dislodged or Dislocated 4 4
Gas Leak 4 4
Device Contaminated During Manufacture or Shipping 4 4
Scratched Material 4 4
Cassette 4 4
Improper or Incorrect Procedure or Method 4 4
Reflux within Device 3 3
Compatibility Problem 3 3
Bent 3 3
Structural Problem 3 3
Device Slipped 3 3
Precipitate in Device or Device Ingredient 2 2
Inaccurate Delivery 2 2
Obstruction of Flow 2 2
Use of Device Problem 2 2
Material Protrusion/Extrusion 2 2
Material Twisted/Bent 2 2
Device Operational Issue 2 2
Device Damaged by Another Device 2 2
Deformation Due to Compressive Stress 2 2
Unintended Ejection 2 2
Material Fragmentation 2 2
Mechanical Problem 2 2
Pressure Problem 2 2
Stopcock 2 2
Regulator 2 2
Adverse Event Without Identified Device or Use Problem 2 2
Increase in Pressure 2 2
Difficult or Delayed Activation 2 2
Device Disinfection Or Sterilization Issue 2 2
Insufficient Flow or Under Infusion 2 2
Contamination 2 2
Material Discolored 2 2
Radiation Leak 2 2
Syringe 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Patient Involvement 3669 3669
No Known Impact Or Consequence To Patient 580 580
No Consequences Or Impact To Patient 541 541
No Information 73 73
Chemical Exposure 21 21
No Code Available 17 17
Fever 8 8
Hemorrhage/Bleeding 5 5
Blood Loss 3 3
Underdose 3 3
Eye Injury 2 2
Exposure to Body Fluids 2 2
Premature Labor 2 2
Laceration(s) 2 2
Pain 2 2
No Clinical Signs, Symptoms or Conditions 2 2
Radiation Exposure, Unintended 1 1
Swelling 1 1
Corneal Abrasion 1 1
Purulent Discharge 1 1
Unspecified Infection 1 1
Thromboembolism 1 1
Dysuria 1 1
Foreign Body In Patient 1 1
Patient Problem/Medical Problem 1 1

Recalls
Manufacturer Recall Class Date Posted
1 B. Braun Medical, Inc. II Jun-02-2016
2 Baxter Corporation Englewood I Oct-06-2016
3 Baxter Healthcare Corporation II Oct-21-2019
4 Baxter Healthcare Corporation II May-22-2018
5 Medimop Medical Projects Ltd. II Mar-12-2018
6 WEST PHARMA. SERVICES IL, LTD I Jan-28-2019
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