TPLC - Total Product Life Cycle

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Device	tube, feeding
Regulation Description	Gastrointestinal tube and accessories.
Product Code	FPD
Regulation Number	876.5980
Device Class	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Malposition of Device	31	31
Adverse Event Without Identified Device or Use Problem	28	28
Break	24	27
Material Deformation	17	17
Material Too Rigid or Stiff	16	16
Leak/Splash	9	9
Insufficient Information	9	9
Material Puncture/Hole	8	9
Material Integrity Problem	7	7
Disconnection	6	6
Obstruction of Flow	5	5
Fluid/Blood Leak	4	4
Material Split, Cut or Torn	4	4
Crack	4	4
Device Markings/Labelling Problem	3	3
Detachment of Device or Device Component	3	3
Material Twisted/Bent	3	3
Material Rupture	3	3
Migration or Expulsion of Device	2	2
Physical Resistance/Sticking	2	2
Complete Blockage	2	2
Connection Problem	2	3
Fracture	2	2
Migration	2	2
Difficult to Remove	2	2
Patient Device Interaction Problem	2	3
Air/Gas in Device	2	2
No Flow	1	1
Mechanical Jam	1	1
Loose or Intermittent Connection	1	1
Difficult to Open or Close	1	1
Material Too Soft/Flexible	1	1
Device Dislodged or Dislocated	1	1
Material Separation	1	1
Incorrect Measurement	1	1
Infusion or Flow Problem	1	1
Structural Problem	1	1
Material Perforation	1	1
Inaccurate Flow Rate	1	1
Gas/Air Leak	1	1
Component Missing	1	1
Material Discolored	1	1
Material Fragmentation	1	1
Inadequate Instructions for Healthcare Professional	1	1
Defective Component	1	1
Device Fell	1	1
Difficult to Advance	1	1
Patient-Device Incompatibility	1	1
Restricted Flow rate	1	1
Incomplete or Missing Packaging	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	45	45
Insufficient Information	23	23
Foreign Body In Patient	21	23
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	13	14
Low Blood Pressure/ Hypotension	11	11
Unspecified Infection	11	11
Bowel Perforation	10	10
No Information	10	10
No Known Impact Or Consequence To Patient	10	10
Bradycardia	9	10
Perforation	9	9
Vomiting	8	8
Perforation of Esophagus	7	7
Vaso-Vagal Response	6	6
Pneumothorax	5	5
Hematuria	5	5
Abscess	4	4
Abdominal Distention	4	4
Hemorrhage/Bleeding	3	3
Hypoxia	3	3
Hyperglycemia	3	3
Skin Discoloration	3	3
Nausea	3	3
Electrolyte Imbalance	2	2
Abnormal Blood Gases	2	2
Apnea	2	2
No Consequences Or Impact To Patient	2	2
Internal Organ Perforation	2	2
Lethargy	2	2
Anemia	1	1
Laceration(s) of Esophagus	1	1
Cardiac Arrest	1	1
Diminished Pulse Pressure	1	1
Pulmonary Emphysema	1	1
Cyst(s)	1	1
Adhesion(s)	1	1
Stomach Ulceration	1	2
Chest Pain	1	1
Increased Intra-Peritoneal Volume (IIPV)	1	1
Necrosis	1	1
Laceration(s)	1	1
Pain	1	1
Choking	1	1
Unspecified Gastrointestinal Problem	1	1
Hypoglycemia	1	1
Gastrointestinal Regurgitation	1	1
Hyponatremia	1	1
Respiratory Distress Syndrome of Newborns	1	1
Pressure Sores	1	1
Ascites	1	1