TPLC - Total Product Life Cycle

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Device	system, applicator, radionuclide, manual
Regulation Description	Manual radionuclide applicator system.
Product Code	IWJ
Regulation Number	892.5650
Device Class	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Unsealed Device Packaging	15	15
Tear, Rip or Hole in Device Packaging	15	15
Device Contamination with Chemical or Other Material	8	8
Leak/Splash	6	6
Physical Resistance/Sticking	4	4
Material Twisted/Bent	4	4
Therapeutic or Diagnostic Output Failure	3	6
Material Deformation	3	3
Break	2	2
Contamination	2	2
Air/Gas in Device	2	2
Decoupling	2	2
Connection Problem	2	3
Loss of or Failure to Bond	2	2
Fitting Problem	1	1
Activation, Positioning or Separation Problem	1	1
Malposition of Device	1	1
Output Problem	1	1
Complete Blockage	1	1
Difficult to Advance	1	1
Positioning Problem	1	1
Material Fragmentation	1	1
Positioning Failure	1	1
Improper Flow or Infusion	1	1
Insufficient Flow or Under Infusion	1	1
Detachment of Device or Device Component	1	1
Device Dislodged or Dislocated	1	1
Device Displays Incorrect Message	1	1
Mechanical Jam	1	4

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	48	48
Insufficient Information	10	11
No Known Impact Or Consequence To Patient	4	7
No Consequences Or Impact To Patient	2	2
Foreign Body In Patient	1	1