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
Insufficient Information	9	9
Leak/Splash	8	8
Material Puncture/Hole	8	9
Material Integrity Problem	7	7
Disconnection	6	6
Obstruction of Flow	5	5
Material Split, Cut or Torn	4	4
Crack	4	4
Fluid/Blood Leak	3	3
Material Rupture	3	3
Complete Blockage	2	2
Physical Resistance/Sticking	2	2
Difficult to Remove	2	2
Patient Device Interaction Problem	2	3
Air/Gas in Device	2	2
Material Twisted/Bent	2	2
Detachment of Device or Device Component	2	2
Connection Problem	2	3
Patient-Device Incompatibility	1	1
Difficult to Advance	1	1
Device Markings/Labelling Problem	1	1
Device Fell	1	1
Defective Component	1	1
Material Fragmentation	1	1
Material Discolored	1	1
Component Missing	1	1
Incomplete or Missing Packaging	1	1
Gas/Air Leak	1	1
Material Perforation	1	1
Structural Problem	1	1
Infusion or Flow Problem	1	1
Mechanical Problem	1	1
Entrapment of Device	1	1
Material Deformation	1	1
Material Separation	1	1
Migration	1	1
Fracture	1	1
Difficult to Open or Close	1	1
Loose or Intermittent Connection	1	1
Mechanical Jam	1	1
Device Slipped	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	36	36
Insufficient Information	25	25
Foreign Body In Patient	20	22
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	13	14
Unspecified Infection	11	11
Low Blood Pressure/ Hypotension	11	11
Bowel Perforation	10	10
Perforation	9	9
Vomiting	7	7
Perforation of Esophagus	7	7
Pneumothorax	5	5
Hematuria	5	5
Abscess	4	4
Abdominal Distention	4	4
Skin Discoloration	3	3
Hyperglycemia	3	3
Bradycardia	3	4
Hypoxia	3	3
Hemorrhage/Bleeding	3	3
Abnormal Blood Gases	2	2
Electrolyte Imbalance	2	2
Nausea	2	2
Apnea	2	2
Internal Organ Perforation	2	2
Low Oxygen Saturation	2	2
Lethargy	2	2
Necrosis	1	1
Adhesion(s)	1	1
Pulmonary Emphysema	1	1
Increased Intra-Peritoneal Volume (IIPV)	1	1
Cyst(s)	1	1
Diminished Pulse Pressure	1	1
Laceration(s) of Esophagus	1	1
Anemia	1	1
Cardiac Arrest	1	1
Stomach Ulceration	1	2
Unspecified Gastrointestinal Problem	1	1
Chest Pain	1	1
Hyponatremia	1	1
Pain	1	1
Laceration(s)	1	1
Choking	1	1
Gastrointestinal Regurgitation	1	1
Ascites	1	1
Respiratory Distress Syndrome of Newborns	1	1
Respiratory Failure	1	1
Hypovolemic Shock	1	1
Distress	1	2

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