TPLC - Total Product Life Cycle

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Device	tube, gastro-enterostomy
Regulation Description	Gastrointestinal tube and accessories.
Product Code	KGC
Regulation Number	876.5980
Device Class	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Break	218	220
Adverse Event Without Identified Device or Use Problem	20	20
Fracture	18	18
Fluid/Blood Leak	15	15
Unintended Movement	13	13
Premature Separation	12	12
Detachment of Device or Device Component	10	11
Loosening of Implant Not Related to Bone-Ingrowth	9	9
Malposition of Device	8	8
Migration	8	8
Fitting Problem	5	5
Entrapment of Device	5	5
Difficult to Remove	5	5
Device Slipped	4	4
Separation Failure	4	4
Material Separation	4	4
Material Deformation	4	4
Material Integrity Problem	4	5
Deformation Due to Compressive Stress	3	3
Separation Problem	3	3
Improper or Incorrect Procedure or Method	3	3
Difficult to Open or Close	3	3
Device Dislodged or Dislocated	3	3
Defective Component	3	3
Material Rupture	3	3
Insufficient Device Problem Information	3	3
Material Twisted/Bent	3	3
Appropriate Device Problem Term/Code Not Available	2	2
Obstruction of Flow	2	2
Use of Device Problem	2	2
Difficult to Insert	2	2
Inadequate Instructions for Healthcare Professional	2	2
Difficult to Advance	2	2
Reflux within Device	2	2
Migration or Expulsion of Device	2	2
Dent in Material	1	1
Gas/Air Leak	1	1
Positioning Failure	1	1
Material Fragmentation	1	1
Defective Device	1	1
Difficult to Flush	1	1
Crack	1	1
Physical Resistance/Sticking	1	1
Failure to Eject	1	1
Failure to Infuse	1	1
Device Appears to Trigger Rejection	1	1
Inadequate or Insufficient Training	1	1
Off-Label Use	1	1
Loose or Intermittent Connection	1	1
Mechanical Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	176	176
Insufficient Information	69	70
Foreign Body In Patient	49	50
Device Embedded In Tissue or Plaque	14	14
Peritonitis	14	14
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available	11	11
Abdominal Pain	11	11
Hemorrhage/Blood Loss/Bleeding	10	10
Pain	10	10
Unspecified Infection	8	8
Skin Inflammation/ Irritation	7	7
Pneumoperitoneum	5	5
Inflammation	4	4
Fever	4	4
Bacterial Infection	4	4
Perforation	4	4
No Consequences Or Impact To Patient	4	4
Erosion	3	3
Sepsis	3	3
Tachycardia	3	3
High White Blood Cell Count	3	3
Skin Infection	2	2
Abscess	2	2
Local Reaction	2	2
Abdominal Cramps	2	2
Abdominal Distention	2	2
Cough	2	2
Gastrointestinal Hemorrhage	2	2
Melena	1	1
Unspecified Gastrointestinal Problem	1	1
Cramp(s) /Muscle Spasm(s)	1	1
Hyperresponsive to stimuli	1	1
Unspecified Blood or Lymphatic problem	1	1
Aspiration Pneumonitis	1	1
Bowel Perforation	1	1
Fluid Discharge	1	1
Rash	1	1
Flatus	1	1
Granuloma	1	1
Bradycardia	1	1
Death	1	1
Purulent Discharge	1	1
Erythema	1	1
Perforation of Vessels	1	2
Vomiting	1	1
Internal Organ Perforation	1	1
Hypersensitivity/Allergic reaction	1	1
Discomfort	1	1
Post Operative Wound Infection	1	1
Medical device site infection	1	1