TPLC - Total Product Life Cycle

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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	21	21
Material Split, Cut or Torn	14	14
Off-Label Use	14	14
Fluid/Blood Leak	13	13
Material Deformation	10	10
Insufficient Information	10	10
Difficult to Remove	10	10
Difficult to Insert	9	9
Partial Blockage	8	8
Defective Component	8	8
Deformation Due to Compressive Stress	7	7
Separation Failure	7	7
Device Contamination with Chemical or Other Material	6	6
Unclear Information	6	6
Component Missing	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	5	5
Incorrect Measurement	4	4
Misassembled	4	4
Material Twisted/Bent	4	4
Leak/Splash	4	4
Material Too Rigid or Stiff	3	3
Component Misassembled	3	3
Nonstandard Device	3	3
Physical Resistance/Sticking	2	2
Fracture	2	2
Suction Problem	2	2
Fitting Problem	2	2
Inaccurate Information	2	2
Biocompatibility	2	2
Obstruction of Flow	1	1
Dent in Material	1	1
Gas/Air Leak	1	1
Positioning Failure	1	1
Decrease in Suction	1	1
Material Perforation	1	1
Blocked Connection	1	1
Patient Device Interaction Problem	1	1
Therapeutic or Diagnostic Output Failure	1	1
Material Puncture/Hole	1	1
Peeled/Delaminated	1	1
Detachment of Device or Device Component	1	1
Malposition of Device	1	1
No Apparent Adverse Event	1	1
Flushing Problem	1	1
Difficult to Open or Close	1	1
Improper or Incorrect Procedure or Method	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	132	132
No Known Impact Or Consequence To Patient	21	21
No Consequences Or Impact To Patient	18	18
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	8	8
Insufficient Information	8	8
Foreign Body In Patient	4	4
Aspiration/Inhalation	3	3
Discomfort	3	3
Hemorrhage/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
Unspecified Gastrointestinal Problem	1	1
Epistaxis	1	1
Exposure to Body Fluids	1	1
Septic Shock	1	1
Gastrointestinal Regurgitation	1	1
Anxiety	1	1
Swelling/ Edema	1	1
Feeding Problem	1	1
Pressure Sores	1	1