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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device cannula, catheter
Regulation Description Catheter cannula.
Product CodeDQR
Regulation Number 870.1300
Device Class 2

Device Problems
Break 51
Activation, Positioning or Separation Problem 43
Positioning Failure 28
Detachment of Device or device Component 9
Adverse Event Without Identified Device or Use Problem 9
Fracture 7
Positioning Problem 7
Device Issue 5
Protective Measures Problem 5
Malposition of device 3
No Device Output 2
Blocked Connection 2
Separation Failure 2
Material Separation 2
Leak / Splash 2
Device Operates Differently Than Expected 2
Device Operational Issue 2
Chemical Problem 2
Component Missing 2
Connection Problem 1
Migration or Expulsion of Device 1
Difficult to Remove 1
Uncoiled 1
Reflux within Device 1
Inadequacy of Device Shape and/or Size 1
Fitting Problem 1
Device, removal of (non-implant) 1
Partial Blockage 1
Wire(s), breakage of 1
Complete Blockage 1
Stylet 1
Other (for use when an appropriate device code cannot be identified) 1
Torn Material 1
Insufficient Information 1
Disconnection 1
Kinked 1
Total Device Problems 202

Recalls
Manufacturer Recall Class Date Posted
1 SPS Sterilization, Inc II Sep-13-2018

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