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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
Regulation Description Intravascular administration set.
Product CodeFMG
Regulation Number 880.5440
Device Class 2


Premarket Reviews
ManufacturerDecision
DYNAREX
  SUBSTANTIALLY EQUIVALENT 1
ELCAM MEDICAL ACAL
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Fluid Leak 214
Leak / Splash 86
Disconnection 70
Stopcock 61
Tube 33
Connection Problem 31
Crack 22
Break 18
Connector 17
Device Contamination with Chemical or Other Material 15
Stopcock Valve 14
Detachment Of Device Component 13
No Flow 11
Device Damaged Prior to Use 10
Infusion or Flow Problem 9
Particulates 8
Loose or Intermittent Connection 8
Mechanical Problem 7
Failure to Prime 7
Port 6
Material Separation 6
Detachment of Device or device Component 6
Kinked 5
Reflux within Device 5
Valve 5
Fracture 5
Filling Problem 5
Insufficient Information 5
Device Dislodged or Dislocated 5
Manifold 4
Blocked Connection 4
Failure to Disconnect 4
Device Operates Differently Than Expected 4
Cap 4
Improper Flow or Infusion 3
Failure to Infuse 3
Free or Unrestricted Flow 3
Material Twisted / Bent 3
Complete Blockage 3
Air Leak 3
Improper or Incorrect Procedure or Method 3
Backflow 3
Device Markings / Labelling Problem 2
Insufficient Flow or Under Infusion 2
Material Split, Cut or Torn 2
Material Protrusion / Extrusion 2
Device Packaging Compromised 2
Y-Piece Connector 2
Material Deformation 2
Luer Valve 2
Plug 2
Junction 1
Bent 1
Misassembled 1
Split 1
Gas Leak 1
Disassembly 1
Retraction Problem 1
Dent in Material 1
Packaging Problem 1
Physical Property Issue 1
Air Eliminator 1
Excess Flow or Over-Infusion 1
Incorrect Device Or Component Shipped 1
Contamination / decontamination Problem 1
Adverse Event Without Identified Device or Use Problem 1
Defective Component 1
Contamination During Use 1
Total Device Problems 786

Recalls
Manufacturer Recall Class Date Posted
1 Elcam Medical, Inc. II Apr-20-2017
2 ICU Medical de Mexico, S.A. de C.V. II Aug-16-2018
3 ICU Medical, Inc. II Oct-04-2018
4 ICU Medical, Inc. II Aug-07-2018
5 ICU Medical, Inc. II Apr-10-2018
6 ICU Medical, Inc. II Nov-17-2017
7 ICU Medical, Inc. II Jun-26-2017
8 ICU Medical, Inc. II Jan-10-2017
9 ICU Medical, Inc. II May-07-2015
10 Smiths Medical ASD Inc. II Jul-05-2019
11 Value Plastics, Inc. II Mar-09-2016
12 Vygon MFG, Inc., dba/ Churchill Medical Systems, Inc. II Feb-21-2018

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