TPLC - Total Product Life Cycle

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Device	port & catheter, implanted, subcutaneous, intravascular
Product Code	LJT
Regulation Number	880.5965
Device Class	2

Premarket Reviews
Manufacturer	Decision
ANGIODYNAMICS, INC.
	SUBSTANTIALLY EQUIVALENT	1
BARD PERIPHERAL VASCULAR, INC.
	SUBSTANTIALLY EQUIVALENT	1
C.R. BARD, INC.
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Fracture	2303	2303
Adverse Event Without Identified Device or Use Problem	1231	1231
Fluid/Blood Leak	1008	1008
Material Separation	884	884
Deformation Due to Compressive Stress	731	731
Migration	595	595
Suction Problem	571	571
Difficult to Flush	423	423
Naturally Worn	420	420
Obstruction of Flow	377	377
Break	302	302
Detachment of Device or Device Component	216	216
Difficult to Remove	160	160
Material Protrusion/Extrusion	159	159
Stretched	150	150
Disconnection	143	143
Component Missing	131	131
Defective Component	125	125
Material Puncture/Hole	111	111
Failure to Advance	99	99
Material Deformation	97	97
Air/Gas in Device	95	95
Migration or Expulsion of Device	93	93
Failure to Infuse	87	87
Difficult to Insert	84	84
Appropriate Term/Code Not Available	81	81
Expulsion	80	80
Material Integrity Problem	74	74
Blocked Connection	73	73
Improper or Incorrect Procedure or Method	70	70
Material Split, Cut or Torn	63	63
Dent in Material	60	60
Physical Resistance/Sticking	60	60
Leak/Splash	57	57
Tear, Rip or Hole in Device Packaging	56	56
Difficult or Delayed Separation	55	55
Material Twisted/Bent	50	50
Device Damaged Prior to Use	49	49
Device Dislodged or Dislocated	44	44
Crack	43	43
Device Appears to Trigger Rejection	43	43
Entrapment of Device	42	42
Device Tipped Over	36	36
Loose or Intermittent Connection	34	34
Infusion or Flow Problem	30	30
Component Misassembled	30	30
Material Frayed	30	30
Insufficient Information	29	29
Device Contamination with Chemical or Other Material	28	28
Device Contaminated During Manufacture or Shipping	26	26

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	2974	2974
No Consequences Or Impact To Patient	708	708
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	593	593
Pain	383	383
Unspecified Infection	342	342
Insufficient Information	266	266
Swelling/ Edema	217	217
Extravasation	208	208
Arrhythmia	184	184
Injury	183	183
Foreign Body In Patient	179	179
Thrombosis/Thrombus	177	177
No Patient Involvement	150	150
Bacterial Infection	145	145
Device Embedded In Tissue or Plaque	90	90
Sepsis	90	90
No Known Impact Or Consequence To Patient	89	89
Skin Erosion	67	67
Swelling	59	59
Embolism	55	55
Embolism/Embolus	46	46
Discomfort	45	45
Pneumothorax	43	43
Chest Pain	42	42
Failure of Implant	35	35
Pulmonary Embolism	35	35
Erythema	34	34
Infiltration into Tissue	29	29
Neck Pain	28	28
Hemorrhage/Bleeding	27	27
Thrombus	25	25
Inflammation	24	24
Hypersensitivity/Allergic reaction	23	23
Fever	23	23
Phlebitis	23	23
Hematoma	22	22
Burning Sensation	20	20
Bruise/Contusion	19	19
Itching Sensation	19	19
Cellulitis	18	18
Fungal Infection	17	17
Rash	16	16
Implant Pain	15	15
Perforation of Vessels	15	15
Wound Dehiscence	14	14
Edema	12	12
Death	11	11
Septic Shock	10	10
No Information	10	10
Tachycardia	10	10

Recalls
Manufacturer		Recall Class	Date Posted
1	Angiodynamics Inc. (Navilyst Medical Inc.)	II	Apr-21-2021
2	Angiodynamics Inc. (Navilyst Medical Inc.)	II	Nov-21-2019
3	Angiodynamics, Inc.	II	Oct-25-2022
4	Bard Peripheral Vascular Inc	II	May-10-2021
5	Bard Peripheral Vascular Inc	II	May-12-2020
6	Bard Peripheral Vascular Inc	II	Mar-26-2020
7	Bard Peripheral Vascular Inc	II	Nov-27-2019
8	Bard Peripheral Vascular Inc	II	Jul-25-2019
9	Medical Components, Inc dba MedComp	II	Mar-08-2021
10	Smiths Medical ASD Inc.	II	Jul-04-2020
11	Smiths Medical ASD Inc.	II	Oct-24-2019