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	35	35
Break	33	36
Adverse Event Without Identified Device or Use Problem	28	28
Complete Blockage	18	18
Leak/Splash	15	15
Obstruction of Flow	12	12
Material Puncture/Hole	11	12
Insufficient Device Problem Information	9	9
Material Integrity Problem	7	7
Material Split, Cut or Torn	6	6
Fluid/Blood Leak	5	5
Pumping Problem	3	3
Material Rupture	3	3
Crack	2	2
Material Twisted/Bent	2	2
Material Deformation	2	2
Fracture	2	2
Disconnection	1	1
Pressure Problem	1	1
Mechanical Problem	1	1
Migration or Expulsion of Device	1	1
Physical Resistance/Sticking	1	1
Difficult to Remove	1	1
Patient Device Interaction Problem	1	1
Material Fragmentation	1	1
Material Discolored	1	1
Material Too Rigid or Stiff	1	1
Gas/Air Leak	1	1
Material Perforation	1	1
Infusion or Flow Problem	1	1
Partial Blockage	1	1
Material Separation	1	1
Detachment of Device or Device Component	1	1
Migration	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	86	86
Insufficient Information	35	35
Foreign Body In Patient	23	25
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available	14	15
Unspecified Infection	11	11
Low Blood Pressure/ Hypotension	11	11
Bowel Perforation	10	10
Perforation	9	9
Pneumothorax	7	7
Perforation of Esophagus	7	7
Vomiting	7	7
Pneumoperitoneum	6	6
Hematuria	5	5
Abdominal Distention	4	4
Bradycardia	4	5
Abscess	4	4
Low Oxygen Saturation	3	3
Skin Discoloration	3	3
Hypoxia	3	3
Hemorrhage/Blood Loss/Bleeding	3	3
Hyperglycemia	3	3
Pressure Sore/Ulcer	3	3
Apnea	2	2
Lethargy	2	2
Nausea	2	2
Unspecified Gastrointestinal Problem	2	2
Abnormal Blood Gases	2	2
Internal Organ Perforation	2	2
Ulcer	2	2
Electrolyte Imbalance	2	2
Distress	1	2
Reduced Blood Flow	1	1
Respiratory Failure	1	1
Metabolic Acidosis	1	1
Ascites	1	1
Respiratory Distress Syndrome of Newborns	1	1
Swelling/ Edema	1	1
Gastrointestinal Regurgitation	1	1
Choking	1	1
Pain	1	1
Laceration(s)	1	1
Chest Pain	1	1
Stomach Ulceration	1	2
Hyperkalemia	1	1
Cardiac Arrest	1	1
Kidney injury	1	1
Laceration(s) of Esophagus	1	1
Anemia	1	1
Diminished Pulse Pressure	1	1
Pulmonary Emphysema	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	ICU Medical, Inc.	II	Sep-09-2022