TPLC - Total Product Life Cycle

show TPLC since

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	7
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	11
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	5
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	7345	7357
Retraction Problem	3320	3335
Break	2660	2673
Fluid/Blood Leak	2036	2046
Device Contamination with Chemical or Other Material	1746	1754
Defective Component	1188	1193
Material Separation	976	984
Material Puncture/Hole	871	877
Deformation Due to Compressive Stress	809	811
Material Twisted/Bent	737	749
Material Deformation	735	736
Material Split, Cut or Torn	649	659
Crack	617	620
Adverse Event Without Identified Device or Use Problem	575	576
Material Protrusion/Extrusion	460	460
Activation Problem	422	426
Contamination	414	429
Physical Resistance/Sticking	383	397
Detachment of Device or Device Component	376	379
Material Frayed	338	338
Unraveled Material	334	334
Defective Device	260	262
Packaging Problem	259	259
Material Integrity Problem	231	231
Difficult or Delayed Activation	223	223
Contamination /Decontamination Problem	223	223
Difficult to Remove	209	209
Obstruction of Flow	188	189
Fracture	188	189
Device Markings/Labelling Problem	171	173
Difficult to Insert	169	169
Fail-Safe Problem	161	161
Product Quality Problem	149	149
Material Rupture	142	142
Complete Blockage	140	140
Difficult to Advance	133	134
Component Missing	131	131
Improper or Incorrect Procedure or Method	125	125
Loose or Intermittent Connection	118	118
Material Perforation	118	121
Nonstandard Device	105	105
Failure to Advance	99	101
Premature Separation	95	125
Connection Problem	90	90
Separation Problem	84	84
Material Fragmentation	83	85
Device Damaged Prior to Use	82	82
Insufficient Information	81	82
Fitting Problem	79	79
Dull, Blunt	70	70

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	20101	20208
No Consequences Or Impact To Patient	2109	2109
Insufficient Information	1987	2036
Foreign Body In Patient	1102	1103
No Known Impact Or Consequence To Patient	1026	1028
Pain	480	487
Needle Stick/Puncture	457	458
No Patient Involvement	423	425
Hemorrhage/Bleeding	216	216
Exposure to Body Fluids	168	169
Extravasation	167	167
Phlebitis	127	127
Device Embedded In Tissue or Plaque	123	124
Swelling/ Edema	103	103
Bacterial Infection	102	103
Perforation of Vessels	95	100
Discomfort	91	96
Hypersensitivity/Allergic reaction	87	87
Thrombosis/Thrombus	86	86
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	81	81
Skin Inflammation/ Irritation	81	81
Hematoma	78	83
Infiltration into Tissue	70	73
Unspecified Infection	68	68
No Code Available	68	68
Erythema	63	63
Bruise/Contusion	56	56
Blood Loss	51	51
Inflammation	51	51
Low Blood Pressure/ Hypotension	43	43
No Information	37	37
Anaphylactic Shock	31	32
Fluid Discharge	24	24
Failure of Implant	23	23
Thrombus	22	22
Laceration(s)	20	20
Air Embolism	18	18
Fever	17	17
Rupture	17	17
Abscess	17	17
Swelling	16	16
Skin Inflammation	15	15
Sepsis	15	15
Chemical Exposure	14	14
Injury	14	14
Necrosis	13	13
Skin Tears	13	13
Death	12	12
Foreign Body Embolism	11	11
Ecchymosis	11	11

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	ARROW INTERNATIONAL, LLC	II	Apr-22-2026
6	Access Vascular, Inc	II	Feb-22-2023
7	Access Vascular, Inc	II	Feb-22-2023
8	Access Vascular, Inc	II	Feb-10-2023
9	Angiodynamics, Inc.	II	Jun-17-2020
10	Arrow International Inc	II	Feb-10-2021
11	Arrow International Inc	II	Jan-22-2020
12	B Braun Medical Inc	II	Mar-19-2025
13	B Braun Medical Inc	II	Oct-06-2022
14	Becton Dickinson & Company	II	Oct-19-2020
15	Becton Dickinson Infusion Therapy Systems Inc.	II	Nov-24-2023
16	Becton Dickinson Infusion Therapy Systems Inc.	II	Oct-03-2023
17	Becton Dickinson Infusion Therapy Systems Inc.	II	Nov-03-2022
18	Becton Dickinson Infusion Therapy Systems Inc.	II	Nov-24-2021
19	Becton Dickinson Infusion Therapy Systems, Inc.	II	Jun-23-2025
20	Becton Dickinson Infusion Therapy Systems, Inc.	II	May-21-2025
21	Becton Dickinson Infusion Therapy Systems, Inc.	II	Jul-31-2024
22	Braxton Medical Corporation	II	Jan-27-2021
23	Cook Inc.	II	Mar-24-2020
24	Cook Incorporated	II	Apr-06-2026
25	Delta Med SpA	II	Aug-16-2021
26	Janus Trade Group	II	Nov-30-2020
27	Mckesson Medical-Surgical Inc. Corporate Office	II	Aug-26-2022
28	Medline Industries, LP	II	May-07-2026
29	Medline Industries, LP	II	Feb-17-2026