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	6
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	3
SPECTRUM VASCULAR
	SUBSTANTIALLY EQUIVALENT	1
VENOCARE, INC.
	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	6347	6347
Retraction Problem	2376	2376
Break	2304	2304
Device Contamination with Chemical or Other Material	1722	1722
Fluid/Blood Leak	1566	1566
Defective Component	1080	1080
Material Separation	857	857
Deformation Due to Compressive Stress	806	806
Material Puncture/Hole	704	707
Material Deformation	676	676
Material Twisted/Bent	518	518
Adverse Event Without Identified Device or Use Problem	515	515
Material Split, Cut or Torn	511	516
Crack	495	495
Material Protrusion/Extrusion	425	425
Physical Resistance/Sticking	330	330
Unraveled Material	307	307
Detachment of Device or Device Component	304	304
Contamination	274	274
Material Frayed	270	270
Activation Problem	255	255
Packaging Problem	252	252
Defective Device	220	220
Difficult or Delayed Activation	220	220
Difficult to Remove	189	189
Device Markings/Labelling Problem	166	166
Obstruction of Flow	160	160
Fracture	159	159
Difficult to Insert	145	145
Complete Blockage	124	124
Fail-Safe Problem	117	117
Improper or Incorrect Procedure or Method	116	116
Component Missing	114	114
Loose or Intermittent Connection	107	107
Material Rupture	105	105
Difficult to Advance	100	100
Material Perforation	95	98
Product Quality Problem	87	87
Fitting Problem	79	79
Material Fragmentation	77	77
Device Damaged Prior to Use	77	77
Material Integrity Problem	71	71
Insufficient Information	70	70
Contamination /Decontamination Problem	68	68
Separation Problem	66	66
Difficult or Delayed Separation	64	64
Failure to Advance	62	62
Separation Failure	61	61
Delivered as Unsterile Product	56	56
Connection Problem	54	54

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	16240	16250
No Consequences Or Impact To Patient	2109	2109
Insufficient Information	1511	1511
No Known Impact Or Consequence To Patient	1025	1025
Foreign Body In Patient	929	929
No Patient Involvement	423	423
Pain	402	402
Needle Stick/Puncture	366	366
Hemorrhage/Bleeding	169	169
Extravasation	149	149
Exposure to Body Fluids	145	145
Phlebitis	110	110
Device Embedded In Tissue or Plaque	109	109
Bacterial Infection	102	102
Hypersensitivity/Allergic reaction	85	85
Skin Inflammation/ Irritation	74	74
Hematoma	69	69
Swelling/ Edema	69	69
No Code Available	68	68
Thrombosis/Thrombus	68	68
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	67	67
Perforation of Vessels	65	70
Discomfort	64	64
Unspecified Infection	59	59
Infiltration into Tissue	54	54
Bruise/Contusion	53	53
Blood Loss	51	51
Erythema	49	49
Inflammation	49	49
No Information	37	37
Low Blood Pressure/ Hypotension	36	36
Anaphylactic Shock	30	30
Failure of Implant	23	23
Thrombus	22	22
Fluid Discharge	18	18
Swelling	16	16
Abscess	16	16
Rupture	15	15
Skin Inflammation	15	15
Fever	15	15
Injury	14	14
Laceration(s)	14	14
Sepsis	14	14
Chemical Exposure	13	13
Death	12	12
Air Embolism	11	11
Foreign Body Embolism	10	10
Reaction	8	8
Hemolysis	8	8
Rash	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	Jun-23-2025
19	Becton Dickinson Infusion Therapy Systems, Inc.	II	May-21-2025
20	Becton Dickinson Infusion Therapy Systems, Inc.	II	Jul-31-2024
21	Braxton Medical Corporation	II	Jan-27-2021
22	Cook Inc.	II	Mar-24-2020
23	Delta Med SpA	II	Aug-16-2021
24	Janus Trade Group	II	Nov-30-2020
25	Mckesson Medical-Surgical Inc. Corporate Office	II	Aug-26-2022