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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
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 776 776

Device Problems MDRs with this Device Problem Events in those MDRs
Fluid Leak 3214 3214
Port 1518 1518
Device Contamination with Chemical or Other Material 726 726
Bag 282 282
Seal 277 277
Leak/Splash 229 229
Break 106 106
Disconnection 100 100
Adapter (Adaptor) 88 88
Connector 73 73
Material Puncture/Hole 73 73
Tube 72 72
Device Operates Differently Than Expected 70 70
Contamination /Decontamination Problem 58 58
Hole In Material 52 52
Cap 39 39
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
Crack 17 17
Excess Flow or Over-Infusion 16 16
Improper Flow or Infusion 16 16
Connection Problem 15 15
Valve(s) 15 15
Loose or Intermittent Connection 14 14
Failure to Align 14 14
Defective Component 13 13
Material Separation 13 13
Detachment Of Device Component 13 13
Material Split, Cut or Torn 13 13
Clamp 11 11
Delivered as Unsterile Product 10 10
Unsealed Device Packaging 10 10
No Flow 10 10
Needle 9 9
Device Markings/Labelling Problem 9 9
Device Packaging Compromised 9 9
Difficult to Open or Close 9 9
Component Missing 9 9
Defective Device 9 9
Particulates 9 9
Misassembled 9 9
Filling Problem 9 9
Cut In Material 8 8
Cannula 8 8
Material Deformation 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
Packaging Problem 6 6
Therapeutic or Diagnostic Output Failure 5 5
Manufacturing, Packaging or Shipping Problem 5 5
Device Damaged Prior to Use 5 5
Air Leak 5 5
Product Quality Problem 5 5
Inflation Problem 5 5
Failure to Prime 4 4
Improper or Incorrect Procedure or Method 4 4
Device Contaminated During Manufacture or Shipping 4 4
Free or Unrestricted Flow 4 4
Gas Leak 4 4
Device Dislodged or Dislocated 4 4
Scratched Material 4 4
Compatibility Problem 3 3
Device Slipped 3 3
Structural Problem 3 3
Reflux within Device 3 3
Bent 3 3
Cassette 3 3
Stopcock 2 2
Label 2 2
Partial Blockage 2 2
Syringe 2 2
Material Discolored 2 2
Contamination 2 2
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
Difficult or Delayed Activation 2 2
Deformation Due to Compressive Stress 2 2
Use of Device Problem 2 2
Inaccurate Delivery 2 2
Device Disinfection Or Sterilization Issue 2 2
Device Operational Issue 2 2
Device Damaged by Another Device 2 2
Pressure Problem 2 2
Tip 2 2
Adverse Event Without Identified Device or Use Problem 2 2
Material Protrusion/Extrusion 2 2
Material Twisted/Bent 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Patient Involvement 3562 3562
No Known Impact Or Consequence To Patient 578 578
No Consequences Or Impact To Patient 522 522
No Information 72 72
Chemical Exposure 21 21
No Code Available 17 17
Fever 8 8
Hemorrhage/Bleeding 5 5
Blood Loss 3 3
Underdose 3 3
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
Dysuria 1 1
Swelling 1 1
Corneal Abrasion 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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