TPLC - Total Product Life Cycle

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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	2
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

Device Problems	MDRs with this Device Problem	Events in those MDRs
Leak/Splash	6168	6168
Break	2244	2244
Retraction Problem	2123	2123
Device Contamination with Chemical or Other Material	1714	1714
Fluid/Blood Leak	1461	1461
Defective Component	1032	1032
Material Separation	840	840
Deformation Due to Compressive Stress	805	805
Material Puncture/Hole	671	674
Material Deformation	669	669
Adverse Event Without Identified Device or Use Problem	508	508
Material Split, Cut or Torn	492	497
Crack	485	485
Material Twisted/Bent	483	483
Material Protrusion/Extrusion	421	421
Physical Resistance/Sticking	317	317
Detachment of Device or Device Component	299	299
Unraveled Material	293	293
Material Frayed	260	260
Contamination	259	259
Packaging Problem	251	251
Activation Problem	236	236
Difficult or Delayed Activation	218	218
Defective Device	216	216
Difficult to Remove	182	182
Device Markings/Labelling Problem	165	165
Fracture	158	158
Obstruction of Flow	156	156
Difficult to Insert	142	142
Complete Blockage	124	124
Fail-Safe Problem	113	113
Improper or Incorrect Procedure or Method	112	112
Component Missing	110	110
Material Rupture	104	104
Loose or Intermittent Connection	102	102
Difficult to Advance	96	96
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 Problem	64	64
Separation Failure	61	61
Failure to Advance	60	60
Delivered as Unsterile Product	54	54
Dull, Blunt	53	53
Infusion or Flow Problem	51	51
Connection Problem	48	48

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	15513	15523
No Consequences Or Impact To Patient	2109	2109
Insufficient Information	1417	1417
No Known Impact Or Consequence To Patient	1025	1025
Foreign Body In Patient	892	892
No Patient Involvement	423	423
Pain	392	392
Needle Stick/Puncture	352	352
Hemorrhage/Bleeding	167	167
Extravasation	148	148
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	74	74
Thrombosis/Thrombus	68	68
No Code Available	68	68
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	67	67
Swelling/ Edema	67	67
Hematoma	66	66
Discomfort	59	59
Perforation of Vessels	57	62
Unspecified Infection	57	57
Blood Loss	51	51
Infiltration into Tissue	51	51
Bruise/Contusion	51	51
Erythema	49	49
Inflammation	49	49
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