TPLC - Total Product Life Cycle

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Device	collector, urine, pediatric, for indwelling catheter
Product Code	FFH
Regulation Number	876.5250
Device Class	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Component Missing	6	6
Material Fragmentation	5	5
Disconnection	4	4
Adverse Event Without Identified Device or Use Problem	4	4
Inaccurate Flow Rate	4	4
No Flow	4	4
Leak/Splash	3	3
Fitting Problem	3	3
Difficult to Remove	3	3
Hole In Material	3	3
Material Twisted/Bent	2	2
Component Misassembled	2	2
Improper or Incorrect Procedure or Method	2	2
Break	2	2
Material Split, Cut or Torn	1	1
Device Markings/Labelling Problem	1	1
Device Damaged Prior to Use	1	1
Short Fill	1	1
Patient-Device Incompatibility	1	1
Kinked	1	1
Defective Device	1	1
Material Integrity Problem	1	1
Unsealed Device Packaging	1	1
Contamination /Decontamination Problem	1	1
Use of Device Problem	1	1
Moisture or Humidity Problem	1	1
Bent	1	1
Material Deformation	1	1
Misassembled	1	1
Device Contamination with Chemical or Other Material	1	1
Contamination of Device Ingredient or Reagent	1	1
Tear, Rip or Hole in Device Packaging	1	1
Device Operates Differently Than Expected	1	1
Gel Leak	1	1
Loose or Intermittent Connection	1	1
No Device Output	1	1
Fluid/Blood Leak	1	1
Difficult to Open or Remove Packaging Material	1	1
Physical Resistance/Sticking	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Known Impact Or Consequence To Patient	19	19
No Clinical Signs, Symptoms or Conditions	17	17
No Consequences Or Impact To Patient	6	6
Unspecified Infection	5	5
No Patient Involvement	5	5
Patient Problem/Medical Problem	3	3
Urinary Tract Infection	3	3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	2	2
No Information	2	2
Foreign Body In Patient	2	2
Insufficient Information	2	2
Pulmonary Infarction	1	1
Bacterial Infection	1	1