TPLC - Total Product Life Cycle

show TPLC since

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	67	67
Fluid/Blood Leak	66	66
Obstruction of Flow	35	35
Adverse Event Without Identified Device or Use Problem	29	29
Break	25	25
Device Dislodged or Dislocated	22	22
Unintended Deflation	19	19
Complete Blockage	13	13
Crack	13	13
Fracture	10	10
Material Rupture	10	10
Material Twisted/Bent	10	10
Leak/Splash	9	9
Suction Problem	9	9
Physical Resistance/Sticking	8	8
Use of Device Problem	8	8
Burst Container or Vessel	7	7
Unintended Movement	7	7
Difficult to Remove	6	6
Material Integrity Problem	6	6
Material Puncture/Hole	6	6
Material Separation	6	6
Decrease in Suction	6	6
Material Split, Cut or Torn	4	4
Difficult to Advance	4	4
No Apparent Adverse Event	4	4
Migration	4	4
Deflation Problem	3	3
Malposition of Device	3	3
Suction Failure	3	3
Material Discolored	2	2
Product Quality Problem	2	2
Device Markings/Labelling Problem	2	2
Disconnection	2	2
Insufficient Information	2	2
Defective Device	2	2
Contamination /Decontamination Problem	2	2
Failure to Analyze Signal	2	2
Protective Measures Problem	2	2
Improper or Incorrect Procedure or Method	2	2
Component Missing	1	1
Structural Problem	1	1
Device Contamination with Chemical or Other Material	1	1
Material Deformation	1	1
Stretched	1	1
Connection Problem	1	1
Nonstandard Device	1	1
Device Appears to Trigger Rejection	1	1
Noise, Audible	1	1
No Display/Image	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	242	242
No Consequences Or Impact To Patient	37	37
Insufficient Information	25	25
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
No Code Available	3	3
Hemorrhage/Bleeding	3	3
Feeding Problem	3	3
No Patient Involvement	3	3
Abdominal Pain	2	2
Death	2	2
Internal Organ Perforation	2	2
Sepsis	2	2
Adult Respiratory Distress Syndrome	2	2
No Information	2	2
Skin Inflammation/ Irritation	2	2
Abdominal Distention	2	2
Fluid Discharge	2	2
Choking	2	2
Pain	2	2
Septic Shock	2	2
Unintended Extubation	1	1
Respiratory Failure	1	1
Low Blood Pressure/ Hypotension	1	1
Erosion	1	1
Renal Impairment	1	1
Dehydration	1	1
Dyspnea	1	1
Discomfort	1	1
Viral Infection	1	1
Strangulation	1	1
Skin Inflammation	1	1
Peritonitis	1	1
Cardiac Arrest	1	1
Multiple Organ Failure	1	1
Purulent Discharge	1	1
Edema	1	1
Inflammation	1	1
Necrosis	1	1
Missed Dose	1	1
Failure of Implant	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