TPLC - Total Product Life Cycle

show TPLC since

Device	tube, double lumen for intestinal decompression and/or intubation
Regulation Description	Gastrointestinal tube and accessories.
Product Code	FEG
Regulation Number	876.5980
Device Class	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Break	26	26
Fluid/Blood Leak	16	16
Material Split, Cut or Torn	14	14
Off-Label Use	14	14
Insufficient Device Problem Information	10	10
Difficult to Remove	9	9
Separation Failure	8	8
Partial Blockage	8	8
Component Misassembled	7	7
Unclear Information	7	7
Defective Component	7	7
Device Contamination with Chemical or Other Material	6	6
Component Missing	6	6
Deformation Due to Compressive Stress	5	5
Material Too Soft/Flexible	5	5
Crack	5	5
Suction Failure	5	5
Adverse Event Without Identified Device or Use Problem	5	5
Nonstandard Device	4	4
Incorrect Measurement	4	4
Misassembled	4	4
Material Fragmentation	4	4
Material Too Rigid or Stiff	3	3
Material Twisted/Bent	2	2
Defective Device	2	2
Physical Resistance/Sticking	2	2
Separation Problem	2	2
Fracture	2	2
Fitting Problem	2	2
Suction Problem	2	2
Inaccurate Information	2	2
Loose or Intermittent Connection	2	2
Leak/Splash	2	2
Biocompatibility	2	2
Positioning Failure	1	1
Dent in Material	1	1
Difficult to Insert	1	1
Decrease in Suction	1	1
Patient Device Interaction Problem	1	1
Material Separation	1	1
Detachment of Device or Device Component	1	1
Malposition of Device	1	1
No Apparent Adverse Event	1	1
Migration	1	1
Increase in Suction	1	1
Difficult to Open or Close	1	1
Improper or Incorrect Procedure or Method	1	1
Disconnection	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	151	151
No Known Impact Or Consequence To Patient	21	21
No Consequences Or Impact To Patient	18	18
Insufficient Information	11	11
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available	9	9
Foreign Body In Patient	4	4
Aspiration/Inhalation	3	3
Discomfort	3	3
Hemorrhage/Blood Loss/Bleeding	3	3
Pneumothorax	2	2
Nausea	2	2
Perforation of Esophagus	2	2
Hematoma	2	2
Perforation	2	2
Vomiting	2	2
Pain	2	2
Anxiety	2	2
Unspecified Gastrointestinal Problem	1	1
Epistaxis	1	1
Fever	1	1
Exposure to Body Fluids	1	1
Septic Shock	1	1
Pressure Sore/Ulcer	1	1
Pneumonia	1	1
Gastrointestinal Regurgitation	1	1
Tachycardia	1	1
Cough	1	1
Swelling/ Edema	1	1
Feeding Problem	1	1
Low Blood Pressure/ Hypotension	1	1
Internal Organ Perforation	1	1
Low Oxygen Saturation	1	1