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
CARDINAL HEALTH
	SUBSTANTIALLY EQUIVALENT	1
GBUK GROUP LTD
	SUBSTANTIALLY EQUIVALENT	1
KB MEDICAL (GROUP) INC.
	SUBSTANTIALLY EQUIVALENT	1
MPS MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	1
ROCKFIELD MEDICAL
	SUBSTANTIALLY EQUIVALENT	2
SYNCRO MEDICAL INNOVATIONS, INC.
	SUBSTANTIALLY EQUIVALENT	1
THREE CIRCLES CONSULTING LIMITED
	SUBSTANTIALLY EQUIVALENT	1
VESCO MEDICAL
	SUBSTANTIALLY EQUIVALENT	1
VESCO MEDICAL LLC
	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	76	76
Fluid/Blood Leak	61	61
Break	37	37
Obstruction of Flow	35	35
Adverse Event Without Identified Device or Use Problem	31	31
Device Dislodged or Dislocated	27	27
Unintended Deflation	21	21
Material Separation	17	17
Complete Blockage	12	12
Material Rupture	10	10
Material Twisted/Bent	10	10
Suction Problem	9	9
Unintended Movement	9	9
Physical Resistance/Sticking	8	8
Crack	8	8
Use of Device Problem	8	8
Leak/Splash	7	7
Burst Container or Vessel	7	7
Fracture	7	7
Material Integrity Problem	7	7
Difficult to Remove	6	6
Material Split, Cut or Torn	5	5
Material Puncture/Hole	5	5
Difficult to Advance	5	5
Decrease in Suction	5	5
Migration	4	4
No Apparent Adverse Event	3	3
Device Contamination with Chemical or Other Material	3	3
Improper or Incorrect Procedure or Method	2	2
Protective Measures Problem	2	2
Product Quality Problem	2	2
Material Deformation	2	2
Contamination /Decontamination Problem	2	2
Deflation Problem	2	2
Defective Device	2	2
Insufficient Information	2	2
Suction Failure	2	2
Device Markings/Labelling Problem	2	2
Malposition of Device	2	2
Pressure Problem	2	2
Disconnection	2	2
Patient Device Interaction Problem	1	1
Stretched	1	1
Material Discolored	1	1
Component Missing	1	1
Inadequate Instructions for Healthcare Professional	1	1
Therapeutic or Diagnostic Output Failure	1	1
Structural Problem	1	1
Manufacturing, Packaging or Shipping Problem	1	1
Unsealed Device Packaging	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	296	296
No Consequences Or Impact To Patient	30	30
Insufficient Information	28	28
Unspecified Infection	13	13
Foreign Body In Patient	9	9
No Known Impact Or Consequence To Patient	9	9
Vomiting	8	8
Aspiration/Inhalation	7	7
Low Oxygen Saturation	6	6
Pneumothorax	6	6
Bradycardia	6	6
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	5	5
Perforation	5	5
Bowel Perforation	4	4
Hemorrhage/Bleeding	3	3
Feeding Problem	3	3
Unspecified Tissue Injury	3	3
Pain	3	3
No Patient Involvement	3	3
Discomfort	3	3
No Code Available	3	3
Abdominal Distention	2	2
Skin Inflammation/ Irritation	2	2
Septic Shock	2	2
Choking	2	2
Sepsis	2	2
Adult Respiratory Distress Syndrome	2	2
Hyperventilation	2	2
Internal Organ Perforation	2	2
Abdominal Pain	2	2
Purulent Discharge	1	1
Multiple Organ Failure	1	1
Cardiac Arrest	1	1
Peritonitis	1	1
No Information	1	1
Strangulation	1	1
Perforation of Esophagus	1	1
Viral Infection	1	1
Necrosis	1	1
Gastrointestinal Hemorrhage	1	1
Respiratory Arrest	1	1
Dehydration	1	1
Renal Impairment	1	1
Fluid Discharge	1	1
Failure of Implant	1	1
Erosion	1	1
Liver Damage/Dysfunction	1	1
Hypersensitivity/Allergic reaction	1	1
Low Blood Pressure/ Hypotension	1	1
Respiratory Failure	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