TPLC - Total Product Life Cycle

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Device	gastrointestinal tubes with enteral specific connectors
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	2
CEDIC S.R.L.
	SUBSTANTIALLY EQUIVALENT	2
GBUK GROUP LTD
	SUBSTANTIALLY EQUIVALENT	1
KB MEDICAL (GROUP) INC.
	SUBSTANTIALLY EQUIVALENT	1
MEDLINE INDUSTRIES, INC.
	SUBSTANTIALLY EQUIVALENT	1
MOSS TUBES, INC.
	SUBSTANTIALLY EQUIVALENT	1
MPS MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	1
ROCKFIELD MEDICAL
	SUBSTANTIALLY EQUIVALENT	2
SYNCRO MEDICAL INNOVATIONS, INC.
	SUBSTANTIALLY EQUIVALENT	1
	SUBSTANTIALLY EQUIVALENT - KIT WITH DRUGS	1
THREE CIRCLES CONSULTING LIMITED
	SUBSTANTIALLY EQUIVALENT	1
U DELIVER MEDICAL, LLC
	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	77	77
Fluid/Blood Leak	67	67
Break	36	36
Obstruction of Flow	35	35
Adverse Event Without Identified Device or Use Problem	30	30
Device Dislodged or Dislocated	25	25
Unintended Deflation	20	20
Material Separation	16	16
Crack	13	13
Complete Blockage	13	13
Material Rupture	10	10
Fracture	10	10
Material Twisted/Bent	10	10
Leak/Splash	9	9
Unintended Movement	9	9
Suction Problem	9	9
Physical Resistance/Sticking	8	8
Use of Device Problem	8	8
Burst Container or Vessel	7	7
Material Integrity Problem	7	7
Decrease in Suction	6	6
Material Puncture/Hole	6	6
Difficult to Remove	6	6
No Apparent Adverse Event	4	4
Migration	4	4
Difficult to Advance	4	4
Material Split, Cut or Torn	4	4
Deflation Problem	3	3
Suction Failure	3	3
Malposition of Device	3	3
Failure to Analyze Signal	2	2
Defective Device	2	2
Insufficient Information	2	2
Contamination /Decontamination Problem	2	2
Protective Measures Problem	2	2
Material Discolored	2	2
Device Markings/Labelling Problem	2	2
Improper or Incorrect Procedure or Method	2	2
Pressure Problem	2	2
Product Quality Problem	2	2
Disconnection	2	2
Connection Problem	1	1
Difficult to Open or Close	1	1
Device Appears to Trigger Rejection	1	1
Nonstandard Device	1	1
Loose or Intermittent Connection	1	1
Device Displays Incorrect Message	1	1
No Flow	1	1
Noise, Audible	1	1
Device Contamination with Chemical or Other Material	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	282	282
No Consequences Or Impact To Patient	37	37
Insufficient Information	28	28
No Known Impact Or Consequence To Patient	20	20
Unspecified Infection	14	14
Vomiting	10	10
Foreign Body In Patient	9	9
Low Oxygen Saturation	8	8
Aspiration/Inhalation	8	8
Bradycardia	6	6
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	5	5
Pneumothorax	5	5
Bowel Perforation	4	4
Perforation	4	4
Hemorrhage/Bleeding	3	3
Feeding Problem	3	3
Unspecified Tissue Injury	3	3
No Patient Involvement	3	3
No Code Available	3	3
Skin Inflammation/ Irritation	2	2
No Information	2	2
Abdominal Distention	2	2
Septic Shock	2	2
Sepsis	2	2
Pain	2	2
Choking	2	2
Fluid Discharge	2	2
Adult Respiratory Distress Syndrome	2	2
Hyperventilation	2	2
Death	2	2
Internal Organ Perforation	2	2
Abdominal Pain	2	2
Inflammation	1	1
Purulent Discharge	1	1
Edema	1	1
Multiple Organ Failure	1	1
Cardiac Arrest	1	1
Peritonitis	1	1
Missed Dose	1	1
Necrosis	1	1
Strangulation	1	1
Respiratory Arrest	1	1
Viral Infection	1	1
Discomfort	1	1
Skin Inflammation	1	1
Dehydration	1	1
Dyspnea	1	1
Renal Impairment	1	1
Failure of Implant	1	1
Liver Damage/Dysfunction	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Boston Scientific Corporation	II	Apr-11-2024
2	Boston Scientific Corporation	II	Feb-16-2024
3	GETINGE US SALES LLC	III	Apr-25-2019