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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device catheter and tip, suction
Regulation Description Vacuum-powered body fluid suction apparatus.
Product CodeJOL
Regulation Number 880.6740
Device Class 2

Device Problems
Fluid Leak 62
Detachment of Device or device Component 55
Leak / Splash 39
Break 36
Device Contamination with Chemical or Other Material 25
Material Separation 22
Adverse Event Without Identified Device or Use Problem 12
Detachment Of Device Component 11
Appropriate Term/Code Not Available 10
Disconnection 8
Use of Device Problem 7
Material Deformation 7
Packaging Problem 6
Hole In Material 5
Device Contaminated during manufacture or shipping 4
Tear, Rip or Hole in Device Packaging 4
Fitting Problem 4
Device Damaged Prior to Use 3
Defective Component 3
Suction Problem 3
Device Inoperable 3
Difficult to Insert 3
Loose or Intermittent Connection 3
Shelf Life Exceeded 2
Fracture 2
No Flow 2
Contamination / decontamination Problem 2
Device Handling Problem 1
Tip 1
No Apparent Adverse Event 1
Failure to Advance 1
Device Operates Differently Than Expected 1
Device Operational Issue 1
Unraveled Material 1
Valve(s), failure of 1
Material Fragmentation 1
Design/structure problem 1
Complete Blockage 1
Hub 1
Air Leak 1
Failure To Adhere Or Bond 1
Tip breakage 1
Kinked 1
Migration or Expulsion of Device 1
Nonstandard device 1
Occlusion Within Device 1
Difficult to Remove 1
Material Too Rigid or Stiff 1
Total Device Problems 364

Recalls
Manufacturer Recall Class Date Posted
1 ConvaTec, Inc II Mar-21-2019
2 Customed, Inc II Apr-14-2016
3 Customed, Inc II Sep-03-2015
4 Teleflex Medical II Feb-16-2019

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