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	5
BARD ACCESS SYSTEMS, INC. (C.R. BARD, INC.)
	SUBSTANTIALLY EQUIVALENT	1
BECTON DICKINSON INFUSION THERAPY SYSTEMS, INC.
	SUBSTANTIALLY EQUIVALENT	8
BECTON, DICKINSON AND COMPANY
	SUBSTANTIALLY EQUIVALENT	1
BECTON, DICKINSON AND COMPANY (BARD ACCESS SYSTEMS, INC.)
	SUBSTANTIALLY EQUIVALENT	1
COOK ADVANCED TECHNOLOGIES
	SUBSTANTIALLY EQUIVALENT	1
MEDIPLUS (INDIA) LIMITED
	SUBSTANTIALLY EQUIVALENT	1
MEDSOURCE INTERNATIONAL, LLC
	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	5243	5255
Retraction Problem	2861	2874
Break	2095	2107
Fluid/Blood Leak	1723	1733
Device Contamination with Chemical or Other Material	1146	1154
Defective Component	1144	1149
Material Separation	852	860
Material Puncture/Hole	795	800
Deformation Due to Compressive Stress	741	742
Material Twisted/Bent	594	603
Material Split, Cut or Torn	540	550
Crack	482	485
Material Deformation	466	467
Adverse Event Without Identified Device or Use Problem	450	451
Contamination	349	364
Activation Problem	329	333
Physical Resistance/Sticking	316	330
Material Protrusion/Extrusion	311	311
Detachment of Device or Device Component	305	306
Unraveled Material	281	281
Material Frayed	280	280
Defective Device	239	241
Packaging Problem	188	188
Difficult to Remove	166	166
Obstruction of Flow	164	165
Difficult or Delayed Activation	164	164
Material Integrity Problem	151	151
Fracture	147	148
Fail-Safe Problem	141	141
Contamination /Decontamination Problem	136	136
Difficult to Insert	132	132
Device Markings/Labelling Problem	123	124
Product Quality Problem	113	113
Component Missing	112	112
Improper or Incorrect Procedure or Method	111	111
Difficult to Advance	109	110
Material Perforation	108	111
Material Rupture	104	104
Loose or Intermittent Connection	99	99
Separation Problem	74	74
Complete Blockage	74	74
Difficult or Delayed Separation	65	65
Material Fragmentation	63	65
Connection Problem	63	63
Failure to Advance	62	62
Fitting Problem	62	62
Separation Failure	61	61
Dull, Blunt	59	59
Mechanical Problem	56	62
Premature Separation	50	50

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	18375	18449
Insufficient Information	1773	1820
Foreign Body In Patient	924	925
No Consequences Or Impact To Patient	484	484
Pain	396	403
Needle Stick/Puncture	361	362
Hemorrhage/Bleeding	185	185
Extravasation	130	130
Exposure to Body Fluids	127	128
Phlebitis	99	99
Bacterial Infection	97	98
Hypersensitivity/Allergic reaction	83	83
Thrombosis/Thrombus	83	83
Swelling/ Edema	79	79
Skin Inflammation/ Irritation	79	79
Discomfort	78	83
Perforation of Vessels	75	80
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	72	72
Device Embedded In Tissue or Plaque	69	69
Hematoma	68	73
Unspecified Infection	56	56
Infiltration into Tissue	56	59
No Patient Involvement	52	52
Bruise/Contusion	47	47
Erythema	38	38
Inflammation	36	36
Low Blood Pressure/ Hypotension	32	32
Anaphylactic Shock	25	26
Failure of Implant	22	22
Fluid Discharge	20	20
Air Embolism	16	16
Rupture	14	14
Laceration(s)	13	13
Sepsis	11	11
Abrasion	11	11
Foreign Body Embolism	10	10
Chemical Exposure	10	10
Skin Tears	10	10
Ecchymosis	9	9
Abscess	9	9
Hemolysis	8	8
Unspecified Tissue Injury	8	9
Rash	8	9
Fever	8	8
Blood Loss	8	8
Tachycardia	7	7
Anxiety	7	7
Skin Discoloration	7	8
Cardiac Arrest	7	7
Easy Bruising	7	7

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	Arrow International Inc	II	Feb-10-2021
9	B Braun Medical Inc	II	Mar-19-2025
10	B Braun Medical Inc	II	Oct-06-2022
11	Becton Dickinson Infusion Therapy Systems Inc.	II	Nov-24-2023
12	Becton Dickinson Infusion Therapy Systems Inc.	II	Oct-03-2023
13	Becton Dickinson Infusion Therapy Systems Inc.	II	Nov-03-2022
14	Becton Dickinson Infusion Therapy Systems Inc.	II	Nov-24-2021
15	Becton Dickinson Infusion Therapy Systems, Inc.	II	Jun-23-2025
16	Becton Dickinson Infusion Therapy Systems, Inc.	II	May-21-2025
17	Becton Dickinson Infusion Therapy Systems, Inc.	II	Jul-31-2024
18	Braxton Medical Corporation	II	Jan-27-2021
19	Delta Med SpA	II	Aug-16-2021
20	Mckesson Medical-Surgical Inc. Corporate Office	II	Aug-26-2022