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
1. K210681 SiteSeal SV
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	611	611
Activation Problem	303	303
Gas/Air Leak	285	285
Deflation Problem	235	235
Failure to Unfold or Unwrap	139	139
Difficult to Open or Close	94	94
Adverse Event Without Identified Device or Use Problem	82	82
Break	80	80
Insufficient Information	62	62
Crack	46	46
Leak/Splash	43	43
Unintended Deflation	33	33
Inflation Problem	31	31
No Apparent Adverse Event	30	30
Detachment of Device or Device Component	26	26
Unraveled Material	25	25
Failure to Seal	23	23
Mechanical Problem	22	22
Premature Activation	19	19
Material Puncture/Hole	19	19
Material Twisted/Bent	16	16
Activation, Positioning or Separation Problem	15	15
Material Separation	13	13
Device Slipped	11	11
Fluid/Blood Leak	10	10
Material Rupture	10	10
Use of Device Problem	9	9
Filling Problem	8	8
Unintended Movement	8	8
Failure to Cut	8	8
Migration	6	6
Burst Container or Vessel	6	6
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
Manufacturing, Packaging or Shipping Problem	5	5
Device Contaminated During Manufacture or Shipping	4	4
Defective Device	4	4
Material Split, Cut or Torn	4	4
Misfire	4	4
Improper or Incorrect Procedure or Method	4	4
Activation Failure	3	3
Failure to Fire	3	3
Peeled/Delaminated	3	3
Melted	3	3
Material Deformation	3	3
Decrease in Pressure	3	3
Deformation Due to Compressive Stress	3	3
Component Missing	3	3

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	1400	1400
No Consequences Or Impact To Patient	334	334
Hemorrhage/Bleeding	154	154
Hematoma	148	148
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