TPLC - Total Product Life Cycle

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Premarket Reviews
Manufacturer	Decision
BEIJING DEMAX MEDICAL TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
BIOREP TECHNOLOGIES, INC
	SUBSTANTIALLY EQUIVALENT	1
CAREFUSION 2200 INC
	SUBSTANTIALLY EQUIVALENT	1
COMPRESSION WORKS INC
	SUBSTANTIALLY EQUIVALENT	1
ENSITE VACULAR, LLC
	SUBSTANTIALLY EQUIVALENT	1
ENSITE VASCULAR
	SUBSTANTIALLY EQUIVALENT	1
KONO SEISAKUSHO CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
MEDICAL INGENUITIES
	SUBSTANTIALLY EQUIVALENT	1
NINGBO DIZEGENS MEDICAL SCIENCE CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
SUNNY MEDICAL DEVICE (SHENZHEN) CO.,LTD.
	SUBSTANTIALLY EQUIVALENT	1
SYNOVIS MICRO COMPANIES ALLIANCE, INC.
	SUBSTANTIALLY EQUIVALENT	1
TERUMO MEDICAL CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
VASCULAR GRAFT SOLUTIONS, LTD.
	SUBSTANTIALLY EQUIVALENT	2
VASOINNOVATIONS, INC
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Fitting Problem	604	604
Activation Problem	297	297
Gas/Air Leak	281	281
Deflation Problem	235	235
Failure to Unfold or Unwrap	138	138
Difficult to Open or Close	94	94
Adverse Event Without Identified Device or Use Problem	82	82
Break	80	80
Insufficient Information	61	61
Crack	46	46
Leak/Splash	43	43
Unintended Deflation	31	31
Inflation Problem	30	30
No Apparent Adverse Event	30	30
Detachment of Device or Device Component	26	26
Unraveled Material	25	25
Mechanical Problem	22	22
Failure to Seal	22	22
Premature Activation	19	19
Material Puncture/Hole	19	19
Activation, Positioning or Separation Problem	15	15
Material Twisted/Bent	13	13
Material Separation	12	12
Fluid/Blood Leak	10	10
Use of Device Problem	9	9
Material Rupture	9	9
Device Slipped	9	9
Unintended Movement	8	8
Failure to Cut	8	8
Filling Problem	6	6
Migration	6	6
Burst Container or Vessel	6	6
Manufacturing, Packaging or Shipping Problem	5	5
Appropriate Term/Code Not Available	5	5
Device Dislodged or Dislocated	5	5
Device Contamination with Chemical or Other Material	5	5
Delivered as Unsterile Product	5	5
Defective Device	4	4
Misfire	4	4
Material Split, Cut or Torn	4	4
Improper or Incorrect Procedure or Method	3	3
Deformation Due to Compressive Stress	3	3
Short Fill	3	3
Activation Failure	3	3
Device Damaged Prior to Use	3	3
Peeled/Delaminated	3	3
Failure to Fire	3	3
Component Missing	3	3
Output Problem	3	3
Material Deformation	3	3

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	1364	1364
No Consequences Or Impact To Patient	334	334
Hemorrhage/Bleeding	154	154
Hematoma	146	146
Insufficient Information	105	105
No Patient Involvement	33	33
Blood Loss	29	29
Pain	19	19
Bruise/Contusion	13	13
Injury	12	12
Numbness	8	8
Death	7	7
Foreign Body In Patient	7	7
Swelling/ Edema	6	6
Pseudoaneurysm	5	5
Necrosis	5	5
Laceration(s)	5	5
No Known Impact Or Consequence To Patient	5	5
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	4	4
Nerve Damage	4	4
Perforation of Vessels	3	3
Thrombosis/Thrombus	3	3
Cramp(s) /Muscle Spasm(s)	3	3
Vascular Dissection	3	3
Neuropathy	3	3
Unspecified Infection	3	3
Cyanosis	3	3
Ventricular Fibrillation	2	2
Cardiac Arrest	2	2
Diminished Pulse Pressure	2	2
No Code Available	2	2
Cardiovascular Insufficiency	2	2
Unspecified Heart Problem	2	2
Nervous System Injury	2	2
Aortic Dissection	1	1
Easy Bruising	1	1
Blister	1	1
Burn(s)	1	1
Needle Stick/Puncture	1	1
Pallor	1	1
Burn, Thermal	1	1
Obstruction/Occlusion	1	1
Embolism/Embolus	1	1
Discomfort	1	1
Perforation	1	1
Heart Failure/Congestive Heart Failure	1	1
Muscle/Tendon Damage	1	1
Failure of Implant	1	1
Unspecified Tissue Injury	1	1
Skin Tears	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Baxter Healthcare Corporation	II	Apr-12-2024
2	Baxter Healthcare Corporation	II	Jan-05-2024
3	Baxter Healthcare Corporation	II	Apr-29-2022
4	Merit Medical Systems, Inc.	II	Apr-24-2020