TPLC - Total Product Life Cycle

Show TPLC since

Device	accessories, catheter
Regulation Description	Introduction/drainage catheter and accessories.
Product Code	KGZ
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