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
TERUMO MEDICAL PRODUCTS (HANGZHOU) CO., LTD.
	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	6931	6943
Retraction Problem	3026	3041
Break	2510	2523
Fluid/Blood Leak	1852	1862
Device Contamination with Chemical or Other Material	1741	1749
Defective Component	1183	1188
Material Separation	942	950
Material Puncture/Hole	812	818
Deformation Due to Compressive Stress	808	810
Material Deformation	711	712
Material Twisted/Bent	624	636
Material Split, Cut or Torn	584	594
Crack	555	558
Adverse Event Without Identified Device or Use Problem	554	555
Material Protrusion/Extrusion	442	442
Physical Resistance/Sticking	360	374
Activation Problem	350	354
Contamination	349	364
Detachment of Device or Device Component	341	344
Unraveled Material	325	325
Material Frayed	305	305
Packaging Problem	256	256
Defective Device	248	250
Difficult or Delayed Activation	222	222
Difficult to Remove	198	198
Obstruction of Flow	177	178
Fracture	176	177
Device Markings/Labelling Problem	170	172
Material Integrity Problem	162	162
Difficult to Insert	161	161
Fail-Safe Problem	146	146
Contamination /Decontamination Problem	137	137
Complete Blockage	129	129
Material Rupture	128	128
Improper or Incorrect Procedure or Method	124	124
Difficult to Advance	123	124
Component Missing	123	123
Product Quality Problem	116	116
Material Perforation	109	112
Loose or Intermittent Connection	108	108
Failure to Advance	82	84
Device Damaged Prior to Use	80	80
Fitting Problem	79	79
Material Fragmentation	78	80
Separation Problem	78	78
Insufficient Information	76	77
Connection Problem	67	67
Dull, Blunt	66	66
Difficult or Delayed Separation	65	65
Separation Failure	63	63

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	18563	18640
No Consequences Or Impact To Patient	2109	2109
Insufficient Information	1818	1867
No Known Impact Or Consequence To Patient	1026	1028
Foreign Body In Patient	1024	1025
Pain	442	449
No Patient Involvement	423	425
Needle Stick/Puncture	417	418
Hemorrhage/Bleeding	195	195
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
Discomfort	84	89
Thrombosis/Thrombus	83	83
Skin Inflammation/ Irritation	79	79
Swelling/ Edema	79	79
Perforation of Vessels	75	80
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	74	74
Hematoma	74	79
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
Fluid Discharge	22	22
Thrombus	22	22
Abscess	17	17
Air Embolism	17	17
Laceration(s)	16	16
Swelling	16	16
Sepsis	15	15
Fever	15	15
Skin Inflammation	15	15
Rupture	15	15
Chemical Exposure	14	14
Injury	14	14
Death	12	12
Foreign Body Embolism	11	11
Abrasion	11	11
Skin Tears	10	10
Cardiac Arrest	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