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

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	4267	4272
Fracture	3477	3479
Material Separation	1343	1343
Fluid/Blood Leak	1222	1225
Deformation Due to Compressive Stress	1063	1063
Migration	1041	1041
Suction Problem	725	725
Difficult to Flush	616	617
Naturally Worn	522	522
Obstruction of Flow	512	515
Detachment of Device or Device Component	281	281
Difficult to Remove	249	249
Stretched	218	218
Expulsion	211	211
Failure to Advance	192	192
Material Protrusion/Extrusion	169	169
Disconnection	164	164
Device Appears to Trigger Rejection	159	159
Material Puncture/Hole	155	156
Material Integrity Problem	142	142
Physical Resistance/Sticking	129	129
Insufficient Information	127	127
Difficult to Insert	118	118
Air/Gas in Device	118	119
Device Damaged Prior to Use	111	111
Blocked Connection	100	100
Improper or Incorrect Procedure or Method	89	89
Component Missing	76	76
Material Twisted/Bent	69	69
Material Deformation	69	69
Difficult or Delayed Separation	68	68
Material Split, Cut or Torn	67	67
Unraveled Material	65	65
Break	65	65
Entrapment of Device	64	64
Defective Component	61	65
Device Tipped Over	61	61
Packaging Problem	60	60
Malposition of Device	57	61
Tear, Rip or Hole in Device Packaging	55	55
Loose or Intermittent Connection	53	53
Device Contaminated During Manufacture or Shipping	51	51
Leak/Splash	49	49
Restricted Flow rate	47	47
Dent in Material	47	47
Device Markings/Labelling Problem	46	46
Loss of or Failure to Bond	46	46
Reflux within Device	44	44
Infusion or Flow Problem	42	42
Component Misassembled	42	42

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	4603	4614
Unspecified Infection	2548	2551
Thrombosis/Thrombus	1637	1640
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	1035	1036
Pain	600	601
Swelling/ Edema	454	455
Extravasation	360	360
Bacterial Infection	323	323
Insufficient Information	305	305
Sepsis	290	290
Foreign Body In Patient	241	241
Arrhythmia	198	198
Skin Erosion	182	182
Obstruction/Occlusion	181	181
Pulmonary Embolism	153	153
Chest Pain	100	100
Fever	96	96
Discomfort	92	92
Embolism/Embolus	81	81
Erythema	74	74
Hemorrhage/Bleeding	56	56
Device Embedded In Tissue or Plaque	48	48
Failure of Implant	47	47
Hematoma	42	42
Pneumothorax	42	42
Neck Pain	42	42
Cellulitis	40	40
Hypersensitivity/Allergic reaction	40	40
Septic Shock	37	37
Infiltration into Tissue	36	36
Implant Pain	36	36
Skin Inflammation/ Irritation	33	34
Drug Resistant Bacterial Infection	33	33
Dyspnea	33	33
Inflammation	32	32
Burning Sensation	30	30
Purulent Discharge	28	28
Bruise/Contusion	26	27
Tachycardia	25	25
Fungal Infection	23	23
Phlebitis	23	23
Itching Sensation	23	23
Rash	22	22
Skin Discoloration	21	21
Wound Dehiscence	20	20
Perforation of Vessels	20	20
Scar Tissue	20	20
Endocarditis	19	19
Stenosis	18	18
Chills	16	16

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