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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Super Search Devices@FDA
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Device saline, vascular access flush
Regulation Description Intravascular catheter.
Definition Enhance the performance of intravascular catheters, to maintain patency of the vascular catheter when it is not in use.
Product CodeNGT
Regulation Number 880.5200
Device Class 2


Premarket Reviews
ManufacturerDecision
AMSINO INTERNATIONAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
BD
  SUBSTANTIALLY EQUIVALENT 2
BECTON DICKINSON AND COMPANY
  SUBSTANTIALLY EQUIVALENT 1
BECTON, DICKINSON & CO.
  SUBSTANTIALLY EQUIVALENT 1
BECTON, DICKINSON AND COMPANY
  SUBSTANTIALLY EQUIVALENT 1
HOSPIRA INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDLINE
  SUBSTANTIALLY EQUIVALENT 2
MEDLINE INDUSTRIES, INC.
  SUBSTANTIALLY EQUIVALENT 2
NURSE ASSIST, INC.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Leak / Splash 236
Packaging Problem 32
Device Contamination with Chemical or Other Material 29
Appropriate Term/Code Not Available 28
Device Markings / Labelling Problem 21
Break 16
Failure to Deliver 14
Volume Accuracy Problem 13
Infusion or Flow Problem 10
Device Contaminated during manufacture or shipping 7
Material Fragmentation 6
Short Fill 6
Manufacturing, Packaging or Shipping Problem 5
Loose or Intermittent Connection 5
Nonstandard device 5
Material Protrusion / Extrusion 4
Adverse Event Without Identified Device or Use Problem 4
Illegible Information 4
Product Quality Problem 4
Material Deformation 3
Delivered as Unsterile Product 3
Material Discolored 3
Inappropriate Audible Prompt / Feedback 2
Unsealed Device Packaging 2
Device Packaging Compromised 2
Device Operates Differently Than Expected 2
Free or Unrestricted Flow 2
Complete Blockage 1
Syringe 1
Fitting Problem 1
No Pressure 1
Pressure Problem 1
Plunger 1
Degraded 1
Defective Component 1
Difficult or Delayed Activation 1
Labelling, Instructions for Use or Training Problem 1
Total Device Problems 478

Recalls
Manufacturer Recall Class Date Posted
1 Becton Dickinson & Company II May-21-2020
2 Becton Dickinson & Company II Nov-20-2019
3 Covidien LLC II Sep-01-2015
4 MRP, LLC dba AMUSA II Aug-27-2015
5 MRP, LLC dba AMUSA II Jun-15-2015
6 MRP, LLC dba AMUSA II Jun-04-2015
7 Medline Industries Inc II Aug-29-2018
8 Nurse Assist, Inc I Jan-03-2017

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