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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device accessories, catheter
Regulation Description Introduction/drainage catheter and accessories.
Product CodeKGZ
Regulation Number 878.4200
Device Class 1

Device Problems
Loss of or Failure to Bond 54
Fluid Leak 39
Leak / Splash 35
Break 26
Failure To Adhere Or Bond 22
Crack 14
Fracture 13
Difficult to Remove 7
Detachment of Device or device Component 7
Material Separation 7
Device Operates Differently Than Expected 7
Unraveled Material 4
Material Frayed 4
Contamination / decontamination Problem 3
Tear, Rip or Hole in Device Packaging 3
Packaging Problem 3
Occlusion Within Device 2
Detachment Of Device Component 2
Device Dislodged or Dislocated 2
Adverse Event Without Identified Device or Use Problem 2
Stretched 1
Defective Component 1
Delamination 1
Device Markings / Labelling Problem 1
Disconnection 1
Inaccurate Flow rate 1
Material Fragmentation 1
Appropriate Term/Code Not Available 1
Entrapment of Device 1
Material Deformation 1
Program or Algorithm Execution Problem 1
Split 1
Difficult to Advance 1
Material Integrity Problem 1
Defective Device 1
Device Damaged by Another Device 1
Fitting Problem 1
Device Contamination with Chemical or Other Material 1
Device Contaminated during manufacture or shipping 1
Delivered as Unsterile Product 1
Device Disinfection Or Sterilization Issue 1
Total Device Problems 277

Recalls
Manufacturer Recall Class Date Posted
1 Arrow International Inc II May-30-2018
2 Cook Inc. II Jun-13-2019
3 Cook Inc. II Mar-02-2017
4 Cook Inc. II Aug-22-2016
5 Galt Medical Corporation II Jul-27-2018
6 Micromedics, Inc. II Apr-12-2017
7 Vascular Solutions, Inc. II Jun-18-2018

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