TPLC - Total Product Life Cycle

show TPLC since

Device	catheter, intravascular, therapeutic, long-term greater than 30 days
Product Code	LJS
Regulation Number	880.5970
Device Class	2

Premarket Reviews
Manufacturer	Decision
ACCESS VASCULAR INC
	SUBSTANTIALLY EQUIVALENT	1
ACCESS VASCULAR, INC
	SUBSTANTIALLY EQUIVALENT	1
ARGON MEDICAL DEVICES
	SUBSTANTIALLY EQUIVALENT	1
ARROW INTERNATIONAL, LLC (A SUBSIDIARY OF TELEFLEX, INC.)
	SUBSTANTIALLY EQUIVALENT	1
BARD ACCESS SYSTEMS, INC.
	SUBSTANTIALLY EQUIVALENT	2
BIOWY CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
C.R. BARD, INC.
	SUBSTANTIALLY EQUIVALENT	1
L&Z US, INC.
	SUBSTANTIALLY EQUIVALENT	3
PICCOLO MEDICAL, INC
	SUBSTANTIALLY EQUIVALENT	1
PICCOLO MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Fluid/Blood Leak	5468	5468
Material Deformation	1625	1625
Break	1425	1425
Fracture	863	863
Defective Component	860	860
Adverse Event Without Identified Device or Use Problem	828	828
Material Frayed	601	601
Component Incompatible	594	594
Crack	518	518
Leak/Splash	450	450
Failure to Infuse	426	426
Material Separation	422	422
Detachment of Device or Device Component	321	321
Material Puncture/Hole	293	293
Material Twisted/Bent	271	271
Contamination /Decontamination Problem	258	258
Device Dislodged or Dislocated	219	219
Data Problem	201	201
Obstruction of Flow	199	199
Material Split, Cut or Torn	187	187
Physical Resistance/Sticking	179	179
Deformation Due to Compressive Stress	148	148
Difficult to Remove	141	141
Material Rupture	139	139
Difficult or Delayed Separation	134	134
Stretched	112	112
Backflow	112	112
Loss of or Failure to Bond	110	110
Difficult to Flush	90	90
Device Markings/Labelling Problem	78	78
Material Fragmentation	76	76
Improper or Incorrect Procedure or Method	75	75
Burst Container or Vessel	66	66
Failure to Advance	66	66
Suction Problem	66	66
Migration	63	63
Difficult to Insert	63	63
Difficult to Advance	61	61
Migration or Expulsion of Device	55	55
Expiration Date Error	54	54
Material Protrusion/Extrusion	53	53
Tear, Rip or Hole in Device Packaging	51	51
Misassembled	51	51
Unable to Obtain Readings	47	47
Component Missing	46	46
Malposition of Device	44	44
No Apparent Adverse Event	44	44
Complete Blockage	42	42
Unraveled Material	41	41
Entrapment of Device	40	40

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	9151	9151
No Consequences Or Impact To Patient	2697	2697
No Known Impact Or Consequence To Patient	1047	1047
Insufficient Information	731	731
Foreign Body In Patient	622	622
Swelling/ Edema	609	609
Erythema	470	470
Pain	303	303
No Patient Involvement	163	163
Extravasation	159	159
Unspecified Infection	158	158
Thrombosis/Thrombus	128	128
No Code Available	121	121
Device Embedded In Tissue or Plaque	111	111
Thrombus	87	87
Hemorrhage/Bleeding	86	86
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	85	85
Infiltration into Tissue	77	77
No Information	76	76
Swelling	64	64
Discomfort	54	54
Fever	47	47
Failure of Implant	45	45
Bacterial Infection	39	39
Skin Inflammation/ Irritation	29	29
Hypersensitivity/Allergic reaction	28	28
Thrombosis	27	27
Purulent Discharge	25	25
Dyspnea	24	24
Chemical Exposure	24	24
Injury	23	23
Inflammation	22	22
Sepsis	21	21
Phlebitis	21	21
Rash	20	20
Hematoma	20	20
Itching Sensation	20	20
Needle Stick/Puncture	19	19
Arrhythmia	18	18
Bruise/Contusion	17	17
Blood Loss	17	17
Death	16	16
Reaction	16	16
Cardiac Arrest	15	15
Perforation of Vessels	15	15
Exposure to Body Fluids	13	13
Burning Sensation	12	12
Laceration(s)	12	12
Cellulitis	12	12
Edema	12	12

Recalls
Manufacturer		Recall Class	Date Posted
1	ARROW INTERNATIONAL Inc.	I	Oct-05-2023
2	ARROW INTERNATIONAL Inc.	II	Sep-15-2023
3	Access Vascular, Inc	II	Oct-13-2023
4	Access Vascular, Inc	II	May-18-2023
5	Access Vascular, Inc.	II	Nov-08-2022
6	Angiodynamics, Inc.	II	Jun-17-2020
7	Argon Medical Devices, Inc	II	Aug-16-2024
8	Arrow International Inc	II	Feb-14-2020
9	Arrow International Inc	II	Jun-16-2019
10	Arrow International Inc	II	May-16-2019
11	Bard Access Systems Inc.	II	Jul-01-2021
12	Bard Access Systems Inc.	II	Jun-30-2021
13	Bard Access Systems Inc.	II	May-20-2021
14	Bard Peripheral Vascular Inc	II	Feb-01-2023
15	Becton Dickinson & Company	II	May-21-2020
16	Medical Components, Inc dba MedComp	II	Oct-25-2019