TPLC - Total Product Life Cycle

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Device	gastrointestinal tubes with enteral specific connectors
Regulation Description	Gastrointestinal tube and accessories.
Definition	To facilitate enteral specific connections.
Product Code	PIF
Regulation Number	876.5980
Device Class	2

Premarket Reviews
Manufacturer	Decision
ANHUI TIANKANG MEDICAL TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
BEIJING L&Z MEDICAL TECHNOLOGY DEVELOPMENT CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
CAIR LGL
	SUBSTANTIALLY EQUIVALENT	2
CARDINALHEALTH
	SUBSTANTIALLY EQUIVALENT	1
GBUK GROUP, LTD.
	SUBSTANTIALLY EQUIVALENT	1
HMC PREMEDICAL S.P.A.
	SUBSTANTIALLY EQUIVALENT	1
KB MEDICAL (GROUP), INC.
	SUBSTANTIALLY EQUIVALENT	1
ROCKFIELD MEDICAL
	SUBSTANTIALLY EQUIVALENT	2
SKY MEDICAL, A.S.
	SUBSTANTIALLY EQUIVALENT	1
VESCO MEDICAL
	SUBSTANTIALLY EQUIVALENT	1
VONCO PRODUCTS
	SUBSTANTIALLY EQUIVALENT	2
WILSON-COOK MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT - WITH DRUG	1
XERIDIEM MEDICAL DEVICES, A SPECTRUM PLASTICS GROUP COMPANY
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Detachment of Device or Device Component	74	74
Break	59	61
Fluid/Blood Leak	46	46
Obstruction of Flow	29	30
Adverse Event Without Identified Device or Use Problem	28	29
Device Dislodged or Dislocated	28	28
Unintended Deflation	24	24
Material Separation	19	19
Leak/Splash	16	16
Unintended Movement	11	11
Difficult to Remove	11	11
Fracture	10	10
Material Rupture	8	8
Material Twisted/Bent	8	9
Insufficient Information	8	8
Complete Blockage	7	7
Material Integrity Problem	7	7
Material Split, Cut or Torn	6	6
Crack	6	6
Suction Problem	5	5
Material Puncture/Hole	5	5
Use of Device Problem	5	6
Defective Device	5	5
Device Contaminated During Manufacture or Shipping	4	4
No Apparent Adverse Event	4	4
Material Deformation	3	3
Product Quality Problem	3	3
Difficult to Advance	3	3
Device Contamination with Chemical or Other Material	3	3
Migration	3	3
Contamination /Decontamination Problem	2	2
Deflation Problem	2	2
Protective Measures Problem	2	3
Human-Device Interface Problem	2	2
Malposition of Device	2	2
Improper or Incorrect Procedure or Method	2	2
Pressure Problem	2	2
Disconnection	2	2
Melted	1	1
Nonstandard Device	1	1
Connection Problem	1	1
Loose or Intermittent Connection	1	1
Noise, Audible	1	1
Inflation Problem	1	1
Structural Problem	1	1
Component Missing	1	1
Material Discolored	1	1
Stretched	1	1
Material Fragmentation	1	1
Patient Device Interaction Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	332	337
Insufficient Information	33	33
Discomfort	11	11
Foreign Body In Patient	11	11
Unspecified Infection	10	10
Bowel Perforation	10	10
Low Oxygen Saturation	8	8
Bradycardia	8	8
Abdominal Pain	7	7
Gastrointestinal Hemorrhage	7	7
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	6	7
Pneumothorax	6	6
Swelling/ Edema	6	6
Aspiration/Inhalation	6	7
Inflammation	6	6
Vomiting	6	7
Burn(s)	6	6
Pain	4	4
Feeding Problem	3	3
Unspecified Tissue Injury	3	3
Internal Organ Perforation	2	2
Hemorrhage/Bleeding	2	2
Hyperventilation	2	2
Anxiety	2	2
Choking	2	2
Septic Shock	2	2
Perforation	2	2
Skin Inflammation/ Irritation	2	2
Sepsis	2	2
Adult Respiratory Distress Syndrome	2	3
No Known Impact Or Consequence To Patient	1	1
Peritonitis	1	1
Strangulation	1	1
Cardiac Arrest	1	1
Viral Infection	1	2
Multiple Organ Failure	1	1
Purulent Discharge	1	1
Dehydration	1	1
Abdominal Distention	1	1
Renal Impairment	1	2
Perforation of Esophagus	1	1
Necrosis	1	1
Respiratory Arrest	1	1
Failure of Implant	1	1
Erosion	1	1
Low Blood Pressure/ Hypotension	1	1
Liver Damage/Dysfunction	1	2
Hypersensitivity/Allergic reaction	1	1
Respiratory Failure	1	1
Unintended Extubation	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Applied Medical Technology Inc	II	Jan-07-2025
2	Boston Scientific Corporation	II	Apr-11-2024
3	Boston Scientific Corporation	II	Feb-16-2024