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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
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
  1.  K183187  nextaro Transfer System, nextaro va
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
Connector 73 73
Tube 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
Detachment of Device or Device Component 18 18
Chemical Spillage 18 18
Material Perforation 18 18
Tear, Rip or Hole in Device Packaging 18 18
Improper Flow or Infusion 17 17
Crack 17 17
Valve(s) 16 16
Excess Flow or Over-Infusion 16 16
Connection Problem 15 15
Failure to Align 14 14
Loose or Intermittent Connection 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
Delivered as Unsterile Product 10 10
No Flow 10 10
Device Packaging Compromised 9 9
Device Markings/Labelling Problem 9 9
Component Missing 9 9
Defective Device 9 9
Misassembled 9 9
Particulates 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
Material Opacification 7 7
Device Alarm System 7 7
Complete Blockage 6 6
Fitting Problem 6 6
Therapeutic or Diagnostic Output Failure 6 6
Packaging Problem 6 6
Manufacturing, Packaging or Shipping Problem 5 5
Free or Unrestricted Flow 5 5
Device Damaged Prior to Use 5 5
Air Leak 5 5
Failure to Prime 5 5
Product Quality Problem 5 5
Inflation Problem 5 5
Cassette 4 4
Improper or Incorrect Procedure or Method 4 4
Gas Leak 4 4
Device Dislodged or Dislocated 4 4
Device Contaminated During Manufacture or Shipping 4 4
Scratched Material 4 4
Compatibility Problem 3 3
Device Slipped 3 3
Structural Problem 3 3
Bent 3 3
Reflux within Device 3 3
Precipitate in Device or Device Ingredient 2 2
Increase in Pressure 2 2
Mechanical Problem 2 2
Radiation Leak 2 2
Unintended Ejection 2 2
Material Fragmentation 2 2
Partial Blockage 2 2
Syringe 2 2
Regulator 2 2
Material Discolored 2 2
Contamination 2 2
Stopcock 2 2
Label 2 2
Obstruction of Flow 2 2
Difficult or Delayed Activation 2 2
Deformation Due to Compressive Stress 2 2
Use of Device Problem 2 2
Insufficient Flow or Under Infusion 2 2
Inaccurate Delivery 2 2
Device Operational Issue 2 2
Device Damaged by Another Device 2 2
Device Disinfection Or Sterilization Issue 2 2
Adverse Event Without Identified Device or Use Problem 2 2
Material Protrusion/Extrusion 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
No Clinical Signs, Symptoms or Conditions 2 2
Laceration(s) 2 2
Pain 2 2
Premature Labor 2 2
Exposure to Body Fluids 2 2
Eye Injury 2 2
Thromboembolism 1 1
Foreign Body In Patient 1 1
Patient Problem/Medical Problem 1 1
Radiation Exposure, Unintended 1 1
Purulent Discharge 1 1
Unspecified Infection 1 1
Corneal Abrasion 1 1
Dysuria 1 1
Swelling 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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