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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device introducer, syringe needle
Regulation Description Syringe needle introducer.
Product CodeKZH
Regulation Number 880.6920
Device Class 2


Premarket Reviews
ManufacturerDecision
MEDTRONIC INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC, INC.
  SUBSTANTIALLY EQUIVALENT 1
YPSOMED AG
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Unintended Ejection 185
Misfire 92
Spring Loading Mechanism 14
Needle 3
Adverse Event Without Identified Device or Use Problem 3
Insufficient Information 2
Headset 1
Break 1
Leak / Splash 1
Cannula 1
Connection Problem 1
Use of Device Problem 1
No Apparent Adverse Event 1
Failure to Fire 1
Device Operates Differently Than Expected 1
Device Operational Issue 1
Total Device Problems 309

Recalls
Manufacturer Recall Class Date Posted
1 International Medsurg Connection, Inc. II Aug-04-2017
2 Owen Mumford USA, Inc. II Nov-01-2019
3 Owen Mumford USA, Inc. II Apr-02-2015

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