TPLC - Total Product Life Cycle

show TPLC since

Device	catheter, intravascular, therapeutic, short-term less than 30 days
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	1
ARROW INTERNATIONAL, LLC (A SUBSIDIARY OF TELEFLEX, INC.)
	SUBSTANTIALLY EQUIVALENT	1
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	2
SPECTRUM VASCULAR
	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	5914	5914
Break	2185	2185
Retraction Problem	1821	1821
Device Contamination with Chemical or Other Material	1677	1677
Fluid/Blood Leak	1286	1286
Defective Component	937	937
Deformation Due to Compressive Stress	805	805
Material Separation	804	804
Material Deformation	650	650
Material Puncture/Hole	640	643
Adverse Event Without Identified Device or Use Problem	500	500
Material Split, Cut or Torn	457	462
Crack	455	455
Material Twisted/Bent	422	422
Material Protrusion/Extrusion	397	397
Physical Resistance/Sticking	306	306
Detachment of Device or Device Component	293	293
Unraveled Material	282	282
Material Frayed	251	251
Packaging Problem	248	248
Contamination	240	240
Activation Problem	222	222
Difficult or Delayed Activation	218	218
Defective Device	206	206
Difficult to Remove	175	175
Device Markings/Labelling Problem	160	160
Fracture	153	153
Obstruction of Flow	145	145
Difficult to Insert	137	137
Complete Blockage	122	122
Component Missing	110	110
Improper or Incorrect Procedure or Method	108	108
Fail-Safe Problem	107	107
Loose or Intermittent Connection	100	100
Material Rupture	97	97
Difficult to Advance	95	95
Material Perforation	90	93
Product Quality Problem	84	84
Fitting Problem	79	79
Device Damaged Prior to Use	77	77
Material Fragmentation	75	75
Insufficient Information	69	69
Failure to Advance	60	60
Separation Problem	58	58
Difficult or Delayed Separation	54	54
Delivered as Unsterile Product	54	54
Separation Failure	53	53
Dull, Blunt	51	51
Infusion or Flow Problem	51	51
Failure to Deliver	45	45

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	14342	14352
No Consequences Or Impact To Patient	2109	2109
Insufficient Information	1289	1289
No Known Impact Or Consequence To Patient	1025	1025
Foreign Body In Patient	856	856
No Patient Involvement	423	423
Pain	369	369
Needle Stick/Puncture	334	334
Hemorrhage/Bleeding	160	160
Exposure to Body Fluids	143	143
Extravasation	140	140
Phlebitis	108	108
Device Embedded In Tissue or Plaque	105	105
Bacterial Infection	102	102
Hypersensitivity/Allergic reaction	83	83
Skin Inflammation/ Irritation	70	70
No Code Available	68	68
Swelling/ Edema	66	66
Thrombosis/Thrombus	65	65
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	64	64
Hematoma	63	63
Unspecified Infection	57	57
Discomfort	53	53
Blood Loss	51	51
Perforation of Vessels	50	55
Infiltration into Tissue	50	50
Inflammation	49	49
Erythema	48	48
Bruise/Contusion	47	47
No Information	37	37
Low Blood Pressure/ Hypotension	31	31
Anaphylactic Shock	28	28
Failure of Implant	23	23
Thrombus	22	22
Abscess	16	16
Swelling	16	16
Fever	15	15
Skin Inflammation	15	15
Rupture	15	15
Fluid Discharge	15	15
Laceration(s)	14	14
Injury	14	14
Chemical Exposure	13	13
Sepsis	12	12
Death	12	12
Foreign Body Embolism	10	10
Air Embolism	10	10
Hemolysis	8	8
Cardiac Arrest	8	8
Reaction	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	Oct-06-2022
12	Becton Dickinson & Company	II	Oct-19-2020
13	Becton Dickinson Infusion Therapy Systems Inc.	II	Nov-24-2023
14	Becton Dickinson Infusion Therapy Systems Inc.	II	Oct-03-2023
15	Becton Dickinson Infusion Therapy Systems Inc.	II	Nov-03-2022
16	Becton Dickinson Infusion Therapy Systems Inc.	II	Nov-24-2021
17	Becton Dickinson Infusion Therapy Systems, Inc.	II	Jul-31-2024
18	Braxton Medical Corporation	II	Jan-27-2021
19	Cook Inc.	II	Mar-24-2020
20	Delta Med SpA	II	Aug-16-2021
21	Janus Trade Group	II	Nov-30-2020
22	Mckesson Medical-Surgical Inc. Corporate Office	II	Aug-26-2022