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	15	15
Off-Label Use	14	14
Material Split, Cut or Torn	12	12
Insufficient Device Problem Information	10	10
Difficult to Remove	9	9
Separation Failure	8	8
Partial Blockage	8	8
Unclear Information	7	7
Defective Component	7	7
Component Misassembled	7	7
Component Missing	6	6
Device Contamination with Chemical or Other Material	6	6
Material Too Soft/Flexible	5	5
Crack	5	5
Suction Failure	5	5
Adverse Event Without Identified Device or Use Problem	5	5
Material Fragmentation	4	4
Incorrect Measurement	4	4
Nonstandard Device	3	3
Material Too Rigid or Stiff	3	3
Biocompatibility	2	2
Deformation Due to Compressive Stress	2	2
Loose or Intermittent Connection	2	2
Inaccurate Information	2	2
Suction Problem	2	2
Fracture	2	2
Material Separation	2	2
Material Twisted/Bent	2	2
Defective Device	2	2
Physical Resistance/Sticking	2	2
Separation Problem	2	2
Fitting Problem	2	2
Leak/Splash	2	2
Decrease in Suction	1	1
Detachment of Device or Device Component	1	1
Dent in Material	1	1
No Apparent Adverse Event	1	1
Migration	1	1
Positioning Failure	1	1
Patient Device Interaction Problem	1	1
Malposition of Device	1	1
Difficult to Open or Close	1	1
Improper or Incorrect Procedure or Method	1	1
Increase in Suction	1	1
Disconnection	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	152	152
Insufficient Information	11	11
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available	10	10
Foreign Body In Patient	4	4
Aspiration/Inhalation	3	3
Discomfort	3	3
Hemorrhage/Blood Loss/Bleeding	3	3
Pneumothorax	2	2
Perforation of Esophagus	2	2
Hematoma	2	2
Perforation	2	2
Vomiting	2	2
Pain	2	2
Anxiety	2	2
Nausea	1	1
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
No Consequences Or Impact To Patient	1	1
Low Blood Pressure/ Hypotension	1	1
Internal Organ Perforation	1	1
Low Oxygen Saturation	1	1