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
1.  K203069  HydroMID
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	3
SPECTRUM VASCULAR
	SUBSTANTIALLY EQUIVALENT	1
VENOCARE, INC.
	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	1852	1852

Device Problems	MDRs with this Device Problem	Events in those MDRs
Leak/Splash	6278	6278
Break	2282	2282
Retraction Problem	2240	2240
Device Contamination with Chemical or Other Material	1719	1719
Fluid/Blood Leak	1513	1513
Defective Component	1054	1054
Material Separation	851	851
Deformation Due to Compressive Stress	805	805
Material Puncture/Hole	686	689
Material Deformation	672	672
Adverse Event Without Identified Device or Use Problem	510	510
Material Twisted/Bent	499	499
Material Split, Cut or Torn	497	502
Crack	490	490
Material Protrusion/Extrusion	425	425
Physical Resistance/Sticking	319	319
Detachment of Device or Device Component	301	301
Unraveled Material	295	295
Contamination	269	269
Material Frayed	267	267
Packaging Problem	252	252
Activation Problem	245	245
Difficult or Delayed Activation	218	218
Defective Device	216	216
Difficult to Remove	183	183
Device Markings/Labelling Problem	166	166
Obstruction of Flow	158	158
Fracture	158	158
Difficult to Insert	143	143
Complete Blockage	124	124
Fail-Safe Problem	117	117
Improper or Incorrect Procedure or Method	113	113
Component Missing	110	110
Loose or Intermittent Connection	106	106
Material Rupture	104	104
Difficult to Advance	98	98
Material Perforation	92	95
Product Quality Problem	85	85
Fitting Problem	79	79
Device Damaged Prior to Use	77	77
Material Fragmentation	76	76
Insufficient Information	69	69
Separation Problem	65	65
Difficult or Delayed Separation	64	64
Separation Failure	61	61
Failure to Advance	60	60
Contamination /Decontamination Problem	60	60
Delivered as Unsterile Product	55	55
Dull, Blunt	53	53
Connection Problem	52	52

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	15903	15913
No Consequences Or Impact To Patient	2109	2109
Insufficient Information	1455	1455
No Known Impact Or Consequence To Patient	1025	1025
Foreign Body In Patient	911	911
No Patient Involvement	423	423
Pain	396	396
Needle Stick/Puncture	359	359
Hemorrhage/Bleeding	167	167
Extravasation	148	148
Exposure to Body Fluids	145	145
Device Embedded In Tissue or Plaque	108	108
Phlebitis	108	108
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
Perforation of Vessels	62	67
Discomfort	62	62
Unspecified Infection	57	57
Infiltration into Tissue	53	53
Bruise/Contusion	51	51
Blood Loss	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
Swelling	16	16
Abscess	16	16
Skin Inflammation	15	15
Fever	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
Reaction	8	8
Cardiac Arrest	8	8
Hemolysis	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