TPLC - Total Product Life Cycle

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Device	port & catheter, implanted, subcutaneous, intravascular
Regulation Description	Subcutaneous, implanted, intravascular infusion port and catheter.
Product Code	LJT
Regulation Number	880.5965
Device Class	2

Premarket Reviews
Manufacturer	Decision
ANGIODYNAMICS, INC.
	SUBSTANTIALLY EQUIVALENT	1
BARD ACCESS SYSTEMS, INC.
	SUBSTANTIALLY EQUIVALENT	1
BARD PERIPHERAL VASCULAR, INC.
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Fracture	2575	2575
Adverse Event Without Identified Device or Use Problem	1669	1669
Fluid/Blood Leak	1018	1018
Material Separation	1003	1003
Deformation Due to Compressive Stress	849	849
Migration	697	697
Suction Problem	594	594
Difficult to Flush	489	489
Naturally Worn	469	469
Obstruction of Flow	416	416
Detachment of Device or Device Component	210	210
Difficult to Remove	188	188
Stretched	173	173
Material Protrusion/Extrusion	167	167
Disconnection	153	153
Material Puncture/Hole	123	123
Expulsion	120	120
Break	118	118
Failure to Advance	117	117
Air/Gas in Device	102	102
Difficult to Insert	100	100
Material Deformation	87	87
Material Integrity Problem	84	84
Blocked Connection	79	79
Component Missing	78	78
Device Damaged Prior to Use	77	77
Migration or Expulsion of Device	77	77
Physical Resistance/Sticking	75	75
Improper or Incorrect Procedure or Method	73	73
Material Split, Cut or Torn	71	71
Defective Component	69	69
Difficult or Delayed Separation	62	62
Dent in Material	60	60
Failure to Infuse	58	58
Material Twisted/Bent	56	56
Tear, Rip or Hole in Device Packaging	54	54
Leak/Splash	52	52
Device Appears to Trigger Rejection	51	51
Insufficient Information	48	48
Entrapment of Device	42	42
Device Tipped Over	39	39
Loose or Intermittent Connection	39	39
Unraveled Material	36	36
Crack	35	35
Component Misassembled	34	34
Device Contaminated During Manufacture or Shipping	33	33
Loss of or Failure to Bond	32	32
Device Dislodged or Dislocated	31	31
Infusion or Flow Problem	30	30
Device Markings/Labelling Problem	30	30

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	3446	3446
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	698	698
Unspecified Infection	639	639
Pain	415	415
Thrombosis/Thrombus	371	371
No Consequences Or Impact To Patient	365	365
Swelling/ Edema	283	283
Insufficient Information	279	279
Extravasation	215	215
Arrhythmia	187	187
Foreign Body In Patient	184	184
Bacterial Infection	173	173
Sepsis	99	99
Skin Erosion	90	90
Injury	84	84
No Patient Involvement	66	66
Device Embedded In Tissue or Plaque	64	64
Discomfort	53	53
Embolism/Embolus	51	51
Chest Pain	46	46
Pneumothorax	43	43
Pulmonary Embolism	40	40
Failure of Implant	37	37
Erythema	36	36
No Known Impact Or Consequence To Patient	36	36
Hemorrhage/Bleeding	36	36
Fever	35	35
Swelling	29	29
Hypersensitivity/Allergic reaction	29	29
Infiltration into Tissue	28	28
Neck Pain	26	26
Inflammation	26	26
Phlebitis	23	23
Hematoma	21	21
Cellulitis	21	21
Burning Sensation	20	20
Bruise/Contusion	20	20
Thrombus	19	19
Obstruction/Occlusion	19	19
Implant Pain	18	18
Itching Sensation	18	18
Fungal Infection	17	17
Rash	16	16
Skin Inflammation/ Irritation	15	15
Perforation of Vessels	15	15
Wound Dehiscence	14	14
Septic Shock	14	14
Dyspnea	13	13
Tachycardia	13	13
Skin Discoloration	11	11

Recalls
Manufacturer		Recall Class	Date Posted
1	Angiodynamics Inc. (Navilyst Medical Inc.)	II	Apr-21-2021
2	Angiodynamics, Inc.	II	Oct-25-2022
3	Bard Peripheral Vascular Inc	II	May-10-2021
4	Bard Peripheral Vascular Inc	II	May-12-2020
5	Bard Peripheral Vascular Inc	II	Mar-26-2020
6	Medical Components, Inc dba MedComp	II	Mar-08-2021
7	Smiths Medical ASD Inc.	II	Jul-04-2020
8	Smiths Medical ASD, Inc.	I	Mar-18-2025