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	3
ARROW INTERNATIONAL, LLC (A SUBSIDIARY OF TELEFLEX, INC.)
	SUBSTANTIALLY EQUIVALENT	2
B. BRAUN MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	6
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	10
BECTON, DICKINSON AND COMPANY
	SUBSTANTIALLY EQUIVALENT	2
BECTON, DICKINSON AND COMPANY (BARD ACCESS 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	4
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	6838	6850
Retraction Problem	2969	2984
Break	2476	2489
Fluid/Blood Leak	1825	1835
Device Contamination with Chemical or Other Material	1739	1747
Defective Component	1183	1188
Material Separation	935	943
Deformation Due to Compressive Stress	807	809
Material Puncture/Hole	802	808
Material Deformation	709	710
Material Twisted/Bent	612	624
Material Split, Cut or Torn	566	576
Adverse Event Without Identified Device or Use Problem	553	554
Crack	547	550
Material Protrusion/Extrusion	436	436
Physical Resistance/Sticking	357	371
Contamination	345	360
Detachment of Device or Device Component	335	338
Activation Problem	334	338
Unraveled Material	323	323
Material Frayed	302	302
Packaging Problem	256	256
Defective Device	248	250
Difficult or Delayed Activation	222	222
Difficult to Remove	196	196
Obstruction of Flow	176	177
Fracture	174	175
Device Markings/Labelling Problem	170	172
Difficult to Insert	156	156
Material Integrity Problem	154	154
Fail-Safe Problem	137	137
Contamination /Decontamination Problem	131	131
Complete Blockage	128	128
Improper or Incorrect Procedure or Method	124	124
Material Rupture	124	124
Difficult to Advance	121	122
Component Missing	121	121
Material Perforation	108	111
Loose or Intermittent Connection	107	107
Product Quality Problem	95	95
Device Damaged Prior to Use	80	80
Failure to Advance	80	82
Fitting Problem	79	79
Separation Problem	78	78
Material Fragmentation	78	80
Insufficient Information	76	77
Difficult or Delayed Separation	65	65
Connection Problem	64	64
Dull, Blunt	64	64
Separation Failure	63	63

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	18278	18355
No Consequences Or Impact To Patient	2109	2109
Insufficient Information	1794	1843
No Known Impact Or Consequence To Patient	1026	1028
Foreign Body In Patient	1013	1014
Pain	435	442
No Patient Involvement	423	425
Needle Stick/Puncture	404	405
Hemorrhage/Bleeding	193	193
Exposure to Body Fluids	165	166
Extravasation	155	155
Device Embedded In Tissue or Plaque	115	116
Phlebitis	112	112
Bacterial Infection	102	103
Hypersensitivity/Allergic reaction	85	85
Thrombosis/Thrombus	83	83
Discomfort	82	87
Skin Inflammation/ Irritation	78	78
Swelling/ Edema	78	78
Perforation of Vessels	73	78
Hematoma	72	77
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	70	70
No Code Available	68	68
Unspecified Infection	67	67
Infiltration into Tissue	66	69
Bruise/Contusion	54	54
Inflammation	51	51
Blood Loss	51	51
Erythema	51	51
Low Blood Pressure/ Hypotension	39	39
No Information	37	37
Anaphylactic Shock	30	31
Failure of Implant	23	23
Thrombus	22	22
Fluid Discharge	21	21
Abscess	17	17
Air Embolism	17	17
Swelling	16	16
Sepsis	15	15
Fever	15	15
Skin Inflammation	15	15
Rupture	15	15
Laceration(s)	14	14
Chemical Exposure	14	14
Injury	14	14
Death	12	12
Foreign Body Embolism	11	11
Abrasion	11	11
Cardiac Arrest	9	9
Ecchymosis	9	9

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