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
DEGANIA SILICONE , LTD.
	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	71	71
Break	57	57
Fluid/Blood Leak	42	42
Device Dislodged or Dislocated	29	29
Adverse Event Without Identified Device or Use Problem	29	30
Obstruction of Flow	29	30
Unintended Deflation	26	26
Material Separation	22	22
Leak/Splash	16	16
Insufficient Device Problem Information	14	14
Fracture	13	13
Unintended Movement	11	11
Material Integrity Problem	10	10
Difficult to Remove	10	10
Material Rupture	8	8
No Apparent Adverse Event	7	7
Complete Blockage	7	7
Material Twisted/Bent	7	7
Difficult to Advance	6	6
Material Puncture/Hole	6	6
Device Contaminated During Manufacture or Shipping	5	5
Material Split, Cut or Torn	5	5
Suction Problem	5	5
Use of Device Problem	4	4
Device Contamination with Chemical or Other Material	3	3
Migration	3	3
Deformation Due to Compressive Stress	3	3
Output Problem	2	2
Failure to Sense	2	2
Material Deformation	2	2
Contamination /Decontamination Problem	2	2
Disconnection	2	2
Human-Device Interface Problem	2	2
Pressure Problem	2	2
Deflation Problem	2	2
Crack	2	2
Malposition of Device	2	2
Suction Failure	1	1
Unsealed Device Packaging	1	1
Material Frayed	1	1
Difficult to Open or Remove Packaging Material	1	1
Material Discolored	1	1
Material Fragmentation	1	1
Component Missing	1	1
Entrapment of Device	1	1
Improper or Incorrect Procedure or Method	1	1
Improper Flow or Infusion	1	1
Melted	1	1
Failure to Analyze Signal	1	1
Noise, Audible	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	361	366
Insufficient Information	43	43
Bowel Perforation	14	14
Foreign Body In Patient	13	13
Low Oxygen Saturation	12	12
Bradycardia	12	12
Discomfort	12	12
Unspecified Infection	10	10
Vomiting	8	9
Abdominal Pain	7	7
Gastrointestinal Hemorrhage	7	7
Swelling/ Edema	6	6
Aspiration/Inhalation	6	7
Pneumothorax	6	6
Inflammation	6	6
Feeding Problem	6	6
Burn(s)	6	6
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available	6	7
Pain	5	5
Unspecified Tissue Injury	4	4
Skin Inflammation/ Irritation	2	2
Anxiety	2	2
Perforation	2	2
Septic Shock	2	2
Respiratory Failure	2	2
Perforation of Esophagus	2	2
Obstruction/Occlusion	2	2
Internal Organ Perforation	2	2
Pulmonary Edema	2	2
Hyperventilation	2	2
Hemorrhage/Blood Loss/Bleeding	2	2
Multiple Organ Dysfunction Syndrome	2	2
Sepsis	2	2
Adult Respiratory Distress Syndrome	2	3
Choking	2	2
Device Embedded In Tissue or Plaque	1	1
Nausea	1	1
Low Blood Pressure/ Hypotension	1	1
No Known Impact Or Consequence To Patient	1	1
Abdominal Distention	1	1
Renal Impairment	1	2
Liver Damage/Dysfunction	1	2
Unintended Extubation	1	1
Pneumoperitoneum	1	1
Respiratory Arrest	1	1
Peritonitis	1	1
Failure of Implant	1	1
Unspecified Gastrointestinal Problem	1	1
Necrosis	1	1
Cardiac Arrest	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Applied Medical Technology Inc	II	Jan-07-2025
2	Boston Scientific Corporation	II	Mar-11-2026
3	Boston Scientific Corporation	II	Apr-11-2024
4	Boston Scientific Corporation	II	Feb-16-2024