TPLC - Total Product Life Cycle

• Device: catheter, intravascular, therapeutic, short-term less than 30 days
• Regulation Description: Intravascular catheter.
• Product Code: FOZ
• Regulation Number: 880.5200
• Device Class: 2

Premarket Reviews
Manufacturer	Decision
ACCESS VASCULAR INC.
	SUBSTANTIALLY EQUIVALENT	1
ACCESS VASCULAR, INC.
	SUBSTANTIALLY EQUIVALENT	1
ARROW INTERNATIONAL, LLC (A SUBSIDIARY OF TELEFLEX, INC.)
	SUBSTANTIALLY EQUIVALENT	2
B. BRAUN MEDICAL INC.
	SUBSTANTIALLY EQUIVALENT	3
B.BRAUN MEDICAL INC.
	SUBSTANTIALLY EQUIVALENT	3
BARD ACCESS SYSTEMS, INC. (BARD HAS JOINED BD)
	SUBSTANTIALLY EQUIVALENT	1
BARD ACCESS SYSTEMS, INC. (C.R. BARD, INC.)
	SUBSTANTIALLY EQUIVALENT	1
BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
	SUBSTANTIALLY EQUIVALENT	4
BECTON, DICKINSON AND COMPANY
	SUBSTANTIALLY EQUIVALENT	2
BECTON, DICKINSON AND COMPANY (BARD ACCESS SYSTEMS, INC.)
	SUBSTANTIALLY EQUIVALENT	1
BECTON, DICKINSON INFUSION THERAPY SYSTEMS, INC.
	SUBSTANTIALLY EQUIVALENT	1
COOK ADVANCED TECHNOLOGIES
	SUBSTANTIALLY EQUIVALENT	1
DELTA MED SPA
	SUBSTANTIALLY EQUIVALENT	1
GLOBAL MEDIKIT LIMITED
	SUBSTANTIALLY EQUIVALENT	1
HEALTH LINE INTERNATIONAL CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
MEDIFIRST CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
MEDIPLUS (INDIA) LIMITED
	SUBSTANTIALLY EQUIVALENT	1
MEDSOURCE INTERNATIONAL LLC
	SUBSTANTIALLY EQUIVALENT	1
MEDSOURCE LABS
	SUBSTANTIALLY EQUIVALENT	1
POLY MEDICURE LIMITED
	SUBSTANTIALLY EQUIVALENT	3
SAUDI MAIS CO. FOR MEDICAL PRODUCTS
	SUBSTANTIALLY EQUIVALENT	1
SHINVA ANDE HEALTHCARE APPARATUS CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
SKYDANCE VASCULAR, INC.
	SUBSTANTIALLY EQUIVALENT	2
SPECTRUM VASCULAR
	SUBSTANTIALLY EQUIVALENT	1
VYGON USA
	SUBSTANTIALLY EQUIVALENT	1
WOO YOUNG MEDICAL CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1

MDR Year	MDR Reports	MDR Events
2020	3796	3796
2021	4673	4673
2022	4133	4138
2023	4431	4434
2024	4775	4777
2025	887	887

Device Problems	MDRs with this Device Problem	Events in those MDRs
Leak/Splash	6066	6066
Break	2220	2220
Retraction Problem	2022	2022
Device Contamination with Chemical or Other Material	1698	1698
Fluid/Blood Leak	1383	1383
Defective Component	990	990
Material Separation	827	827
Deformation Due to Compressive Stress	805	805
Material Deformation	666	666
Material Puncture/Hole	662	665
Adverse Event Without Identified Device or Use Problem	507	507
Material Split, Cut or Torn	484	489
Crack	476	476
Material Twisted/Bent	466	466
Material Protrusion/Extrusion	415	415
Physical Resistance/Sticking	315	315
Detachment of Device or Device Component	299	299
Unraveled Material	286	286
Material Frayed	258	258
Contamination	254	254
Packaging Problem	251	251
Activation Problem	230	230
Difficult or Delayed Activation	218	218
Defective Device	215	215
Difficult to Remove	182	182
Device Markings/Labelling Problem	164	164
Fracture	156	156
Obstruction of Flow	148	148
Difficult to Insert	140	140
Complete Blockage	124	124
Fail-Safe Problem	111	111
Improper or Incorrect Procedure or Method	110	110
Component Missing	110	110
Material Rupture	101	101
Loose or Intermittent Connection	101	101
Difficult to Advance	95	95
Material Perforation	91	94
Product Quality Problem	84	84
Fitting Problem	79	79
Device Damaged Prior to Use	77	77
Material Fragmentation	75	75
Insufficient Information	69	69
Difficult or Delayed Separation	64	64
Separation Failure	61	61
Separation Problem	61	61
Failure to Advance	60	60
Delivered as Unsterile Product	54	54
Dull, Blunt	52	52
Infusion or Flow Problem	51	51
Contamination /Decontamination Problem	47	47

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	15079	15089
No Consequences Or Impact To Patient	2109	2109
Insufficient Information	1363	1363
No Known Impact Or Consequence To Patient	1025	1025
Foreign Body In Patient	877	877
No Patient Involvement	423	423
Pain	382	382
Needle Stick/Puncture	349	349
Hemorrhage/Bleeding	167	167
Extravasation	147	147
Exposure to Body Fluids	145	145
Phlebitis	108	108
Device Embedded In Tissue or Plaque	105	105
Bacterial Infection	102	102
Hypersensitivity/Allergic reaction	85	85
Skin Inflammation/ Irritation	71	71
No Code Available	68	68
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	66	66
Thrombosis/Thrombus	66	66
Swelling/ Edema	66	66
Hematoma	65	65
Discomfort	59	59
Unspecified Infection	57	57
Perforation of Vessels	54	59
Blood Loss	51	51
Infiltration into Tissue	51	51
Bruise/Contusion	51	51
Inflammation	49	49
Erythema	48	48
No Information	37	37
Low Blood Pressure/ Hypotension	33	33
Anaphylactic Shock	28	28
Failure of Implant	23	23
Thrombus	22	22
Fluid Discharge	18	18
Abscess	16	16
Swelling	16	16
Fever	15	15
Skin Inflammation	15	15
Rupture	15	15
Laceration(s)	14	14
Injury	14	14
Chemical Exposure	13	13
Sepsis	12	12
Death	12	12
Air Embolism	11	11
Foreign Body Embolism	10	10
Hemolysis	8	8
Cardiac Arrest	8	8
Reaction	8	8

Recalls
Manufacturer		Recall Class	Date Posted
1	ARROW INTERNATIONAL Inc.	I	Oct-05-2023
2	ARROW INTERNATIONAL Inc.	I	Jun-21-2023
3	ARROW INTERNATIONAL Inc.	I	Dec-10-2022
4	ARROW INTERNATIONAL Inc.	II	Jun-27-2022
5	Access Vascular, Inc	II	Feb-22-2023
6	Access Vascular, Inc	II	Feb-22-2023
7	Access Vascular, Inc	II	Feb-10-2023
8	Angiodynamics, Inc.	II	Jun-17-2020
9	Arrow International Inc	II	Feb-10-2021
10	Arrow International Inc	II	Jan-22-2020
11	B Braun Medical Inc	II	Mar-19-2025
12	B Braun Medical Inc	II	Oct-06-2022
13	Becton Dickinson & Company	II	Oct-19-2020
14	Becton Dickinson Infusion Therapy Systems Inc.	II	Nov-24-2023
15	Becton Dickinson Infusion Therapy Systems Inc.	II	Oct-03-2023
16	Becton Dickinson Infusion Therapy Systems Inc.	II	Nov-03-2022
17	Becton Dickinson Infusion Therapy Systems Inc.	II	Nov-24-2021
18	Becton Dickinson Infusion Therapy Systems, Inc.	II	Jul-31-2024
19	Braxton Medical Corporation	II	Jan-27-2021
20	Cook Inc.	II	Mar-24-2020
21	Delta Med SpA	II	Aug-16-2021
22	Janus Trade Group	II	Nov-30-2020
23	Mckesson Medical-Surgical Inc. Corporate Office	II	Aug-26-2022