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	3588	3592
Fracture	3158	3160
Material Separation	1207	1207
Fluid/Blood Leak	1123	1126
Deformation Due to Compressive Stress	975	975
Migration	928	928
Suction Problem	669	669
Difficult to Flush	577	578
Naturally Worn	493	493
Obstruction of Flow	419	422
Detachment of Device or Device Component	260	260
Difficult to Remove	225	225
Stretched	203	203
Expulsion	195	195
Material Protrusion/Extrusion	167	167
Failure to Advance	163	163
Disconnection	145	145
Material Puncture/Hole	143	144
Material Integrity Problem	128	128
Device Appears to Trigger Rejection	126	126
Air/Gas in Device	114	115
Difficult to Insert	113	113
Device Damaged Prior to Use	111	111
Insufficient Information	110	110
Physical Resistance/Sticking	108	108
Blocked Connection	94	94
Improper or Incorrect Procedure or Method	85	85
Difficult or Delayed Separation	66	66
Material Split, Cut or Torn	64	64
Material Twisted/Bent	62	62
Break	61	61
Defective Component	61	65
Entrapment of Device	57	57
Material Deformation	56	56
Unraveled Material	56	56
Device Tipped Over	55	55
Tear, Rip or Hole in Device Packaging	52	52
Component Missing	51	51
Malposition of Device	48	52
Leak/Splash	47	47
Dent in Material	47	47
Device Contaminated During Manufacture or Shipping	47	47
Packaging Problem	47	47
Restricted Flow rate	42	42
Device Markings/Labelling Problem	40	40
Loose or Intermittent Connection	40	40
Infusion or Flow Problem	39	39
Loss of or Failure to Bond	38	38
Component Misassembled	37	37
Reflux within Device	35	35

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	4257	4268
Unspecified Infection	2111	2113
Thrombosis/Thrombus	1319	1321
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	944	945
Pain	538	539
Swelling/ Edema	390	391
Insufficient Information	297	297
Extravasation	291	291
Bacterial Infection	249	249
Foreign Body In Patient	220	220
Sepsis	212	212
Arrhythmia	196	196
Skin Erosion	166	166
Obstruction/Occlusion	118	118
Pulmonary Embolism	109	109
Fever	85	85
Chest Pain	84	84
Discomfort	77	77
Embolism/Embolus	68	68
Erythema	60	60
Hemorrhage/Bleeding	47	47
Failure of Implant	46	46
Device Embedded In Tissue or Plaque	45	45
Pneumothorax	42	42
Neck Pain	36	36
Hematoma	35	35
Infiltration into Tissue	35	35
Cellulitis	34	34
Hypersensitivity/Allergic reaction	33	33
Implant Pain	31	31
Septic Shock	29	29
Skin Inflammation/ Irritation	29	30
Dyspnea	28	28
Inflammation	28	28
Burning Sensation	27	27
Bruise/Contusion	24	25
Phlebitis	23	23
Itching Sensation	22	22
Tachycardia	21	21
Rash	21	21
Perforation of Vessels	20	20
Scar Tissue	19	19
Fungal Infection	18	18
Skin Discoloration	17	17
No Consequences Or Impact To Patient	15	15
Stenosis	15	15
Wound Dehiscence	15	15
Air Embolism	14	14
Nausea	14	14
Stroke/CVA	14	14

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