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
BARD ACCESS SYSTEMS, INC.
	SUBSTANTIALLY EQUIVALENT	3
BARD PERIPHERAL VASCULAR, INC.
	SUBSTANTIALLY EQUIVALENT	1
PORTAL ACCESS, INC.
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	4815	4818
Fracture	3765	3767
Material Separation	1498	1498
Fluid/Blood Leak	1354	1357
Migration	1215	1215
Deformation Due to Compressive Stress	1169	1169
Suction Problem	816	816
Difficult to Flush	679	680
Device Appears to Trigger Rejection	666	666
Obstruction of Flow	652	653
Naturally Worn	569	569
Detachment of Device or Device Component	288	288
Expulsion	271	271
Difficult to Remove	269	269
Stretched	238	238
Failure to Advance	213	213
Material Protrusion/Extrusion	173	173
Disconnection	170	170
Material Puncture/Hole	164	165
Material Integrity Problem	157	157
Insufficient Device Problem Information	142	142
Physical Resistance/Sticking	136	136
Difficult to Insert	129	129
Air/Gas in Device	124	125
Blocked Connection	119	119
Device Damaged Prior to Use	111	111
Improper or Incorrect Procedure or Method	100	100
Material Twisted/Bent	87	87
Component Missing	77	77
Device Tipped Over	75	75
Material Split, Cut or Torn	73	73
Material Deformation	73	73
Unraveled Material	71	71
Difficult or Delayed Separation	69	69
Packaging Problem	68	68
Malposition of Device	64	68
Entrapment of Device	64	64
Defective Component	60	64
Tear, Rip or Hole in Device Packaging	59	59
Loose or Intermittent Connection	59	59
Device Contaminated During Manufacture or Shipping	54	54
Restricted Flow rate	53	53
Device Markings/Labelling Problem	49	49
Nonstandard Device	47	47
Loss of or Failure to Bond	47	47
Dent in Material	47	47
Break	46	46
Reflux within Device	45	45
Component Misassembled	42	42
Infusion or Flow Problem	38	38

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	4934	4945
Unspecified Infection	3182	3185
Thrombosis/Thrombus	2061	2064
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available	1138	1139
Pain	685	686
Swelling/ Edema	529	530
Extravasation	439	439
Bacterial Infection	410	410
Sepsis	404	404
Insufficient Information	324	324
Foreign Body In Patient	275	275
Obstruction/Occlusion	265	265
Skin Erosion	244	244
Bacteremia	242	242
Pulmonary Embolism	207	207
Arrhythmia	200	200
Erythema	124	124
Chest Pain	117	117
Discomfort	115	115
Fever	105	105
Embolism/Embolus	99	99
Hemorrhage/Blood Loss/Bleeding	59	59
Cellulitis	55	55
Purulent Discharge	54	54
Neck Pain	51	51
Device Embedded In Tissue or Plaque	49	49
Drug Resistant Bacterial Infection	47	47
Failure of Implant	47	47
Pneumothorax	46	46
Hematoma	46	46
Hypersensitivity/Allergic reaction	44	44
Implant Pain	42	42
Septic Shock	41	41
Skin Inflammation/ Irritation	41	42
Inflammation	39	39
Infiltration into Tissue	37	37
Dyspnea	35	35
Burning Sensation	34	34
Bruise/Contusion	32	33
Tachycardia	32	32
Medical device site infection	30	30
Itching Sensation	28	28
Rash	26	26
Skin Discoloration	25	25
Perforation of Vessels	24	24
Vasculitis	23	23
Wound Dehiscence	23	23
Fungal Infection	23	23
Pneumonia	23	23
Pleural Effusion	22	22

Recalls
Manufacturer		Recall Class	Date Posted
1	ARROW INTERNATIONAL, LLC	I	Jun-13-2026
2	Angiodynamics Inc. (Navilyst Medical Inc.)	II	Apr-21-2021
3	Angiodynamics, Inc.	II	Oct-25-2022
4	B.Braun Medical S.A.S.	II	Sep-05-2025
5	Bard Peripheral Vascular Inc	II	May-10-2021
6	Medical Components, Inc dba MedComp	II	Mar-08-2021
7	Smiths Medical ASD, Inc.	I	Mar-18-2025