TPLC - Total Product Life Cycle

show TPLC since

Device	catheter, hemodialysis, implanted
Product Code	MSD
Regulation Number	876.5540
Device Class	2

Premarket Reviews
Manufacturer	Decision
BARD PERIPHERAL VASCULAR, INC
	SUBSTANTIALLY EQUIVALENT - KIT	1
C B BARD, INC
	SUBSTANTIALLY EQUIVALENT - KIT	1
C R BARD, INC
	SUBSTANTIALLY EQUIVALENT - KIT	1
C.R. BARD
	SUBSTANTIALLY EQUIVALENT - KIT	1
C.R. BARD, INC.
	SUBSTANTIALLY EQUIVALENT - KIT	2
MEDICAL COMPONENTS INC. (DBA MEDCOMP)
	SUBSTANTIALLY EQUIVALENT	1
MEDICAL COMPONENTS INC. (MEDCOMP)
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Fracture	409	409
Fluid/Blood Leak	318	318
Break	282	282
Material Puncture/Hole	247	247
Deformation Due to Compressive Stress	217	217
Material Deformation	163	163
Crack	159	159
Detachment of Device or Device Component	149	149
Material Opacification	117	117
Stretched	113	113
Obstruction of Flow	111	111
Material Separation	110	110
Adverse Event Without Identified Device or Use Problem	108	108
Restricted Flow rate	107	107
Leak/Splash	102	102
Insufficient Flow or Under Infusion	92	92
Difficult to Remove	91	91
Air/Gas in Device	83	83
Material Integrity Problem	83	83
Defective Component	83	83
Material Protrusion/Extrusion	77	77
Migration	64	64
Loosening of Implant Not Related to Bone-Ingrowth	60	60
Suction Problem	58	58
Expulsion	58	58
Material Discolored	57	57
Product Quality Problem	51	51
Collapse	43	43
Failure to Advance	39	39
Material Twisted/Bent	39	39
Physical Resistance/Sticking	30	30
Material Fragmentation	30	30
Difficult to Insert	29	29
Insufficient Information	27	27
Infusion or Flow Problem	26	26
Loss of or Failure to Bond	26	26
Material Split, Cut or Torn	25	25
Packaging Problem	25	25
Improper or Incorrect Procedure or Method	25	25
Melted	23	23
Unraveled Material	23	23
Difficult to Flush	23	23
Difficult or Delayed Separation	22	22
Disconnection	22	22
Device Markings/Labelling Problem	21	21
Contamination /Decontamination Problem	19	19
Migration or Expulsion of Device	19	19
Gas/Air Leak	18	18
Unsealed Device Packaging	15	15
Separation Failure	15	15

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	2106	2106
Insufficient Information	213	213
No Consequences Or Impact To Patient	209	209
Hemorrhage/Bleeding	80	80
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	65	65
Unspecified Infection	61	61
No Known Impact Or Consequence To Patient	51	51
Thrombosis/Thrombus	47	47
Unintended Radiation Exposure	27	27
Bacterial Infection	26	26
Foreign Body In Patient	23	23
Air Embolism	21	21
Sepsis	16	16
No Patient Involvement	16	16
Device Embedded In Tissue or Plaque	14	14
Fever	14	14
Low Blood Pressure/ Hypotension	12	12
Cardiac Arrest	12	12
Swelling/ Edema	11	11
Pain	11	11
Hematoma	11	11
Failure of Implant	10	10
No Information	10	10
Blood Loss	9	9
Injury	8	8
Drug Resistant Bacterial Infection	7	7
Perforation of Vessels	7	7
Exsanguination	7	7
Chest Pain	6	6
Embolism/Embolus	6	6
Purulent Discharge	6	6
Loss of consciousness	5	5
Stenosis	5	5
Shock	5	5
Cardiac Tamponade	5	5
Peritonitis	4	4
Death	4	4
Skin Erosion	4	4
Dyspnea	4	4
No Code Available	4	4
Erythema	4	4
Distress	3	3
Respiratory Failure	3	3
Dizziness	3	3
Pneumothorax	3	3
Tissue Damage	3	3
Chills	3	3
Unspecified Tissue Injury	3	3
Fluid Discharge	3	3
Encephalopathy	2	2

Recalls
Manufacturer		Recall Class	Date Posted
1	Angiodynamics, Inc.	II	May-03-2024
2	Bard Peripheral Vascular Inc	II	Jun-03-2020
3	Covidien LP	II	Apr-24-2024
4	Covidien LP	II	Sep-25-2023
5	Covidien Llc	I	Jul-07-2022
6	Covidien, LP	II	Aug-27-2021
7	MARVAO MEDICAL DEVICES LTD.	II	Jun-01-2021
8	Medical Components, Inc dba MedComp	II	Sep-06-2020