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	23	23
Off-Label Use	14	14
Fluid/Blood Leak	12	12
Material Split, Cut or Torn	11	11
Insufficient Information	10	10
Difficult to Remove	9	9
Partial Blockage	8	8
Separation Failure	7	7
Unclear Information	7	7
Defective Component	7	7
Device Contamination with Chemical or Other Material	6	6
Component Missing	6	6
Material Too Soft/Flexible	5	5
Crack	5	5
Suction Failure	5	5
Material Fragmentation	4	4
Adverse Event Without Identified Device or Use Problem	4	4
Material Twisted/Bent	4	4
Nonstandard Device	3	3
Component Misassembled	3	3
Material Too Rigid or Stiff	3	3
Incorrect Measurement	3	3
Biocompatibility	2	2
Loose or Intermittent Connection	2	2
Inaccurate Information	2	2
Suction Problem	2	2
Fracture	2	2
Migration	2	2
Defective Device	2	2
Physical Resistance/Sticking	2	2
Separation Problem	2	2
Fitting Problem	2	2
Leak/Splash	2	2
Gas/Air Leak	1	1
Decrease in Suction	1	1
Blocked Connection	1	1
Dent in Material	1	1
Material Deformation	1	1
Obstruction of Flow	1	1
Use of Device Problem	1	1
Detachment of Device or Device Component	1	1
Positioning Failure	1	1
No Apparent Adverse Event	1	1
Patient Device Interaction Problem	1	1
Device Markings/Labelling Problem	1	1
Flushing Problem	1	1
Peeled/Delaminated	1	1
Malposition of Device	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	137	137
Insufficient Information	10	10
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	9	9
Foreign Body In Patient	4	4
Aspiration/Inhalation	3	3
Discomfort	3	3
Hemorrhage/Bleeding	3	3
Pneumothorax	2	2
Perforation of Esophagus	2	2
Hematoma	2	2
Perforation	2	2
Vomiting	2	2
Pain	2	2
Nausea	1	1
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
No Consequences Or Impact To Patient	1	1
Pressure Sores	1	1
Internal Organ Perforation	1	1