TPLC - Total Product Life Cycle

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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
PRISTINE ACCESS TECHNOLOGIES LTD.
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Fracture	400	400
Fluid/Blood Leak	347	347
Defective Component	318	318
Break	311	311
Material Puncture/Hole	286	286
Deformation Due to Compressive Stress	191	191
Crack	182	182
Material Deformation	174	174
Detachment of Device or Device Component	154	154
Leak/Splash	123	123
Material Opacification	117	117
Stretched	111	111
Obstruction of Flow	111	111
Material Separation	109	109
Restricted Flow rate	97	97
Difficult to Remove	91	91
Material Integrity Problem	91	91
Insufficient Flow or Under Infusion	84	84
Air/Gas in Device	79	79
Adverse Event Without Identified Device or Use Problem	76	76
Material Protrusion/Extrusion	73	73
Material Discolored	59	59
Suction Problem	58	58
Loosening of Implant Not Related to Bone-Ingrowth	54	54
Product Quality Problem	53	53
Expulsion	51	51
Migration	48	48
Component Missing	44	44
Failure to Advance	38	38
Disconnection	34	34
Material Twisted/Bent	32	32
Device Dislodged or Dislocated	32	32
Physical Resistance/Sticking	31	31
Material Fragmentation	31	31
Material Frayed	29	29
Difficult to Insert	29	29
Infusion or Flow Problem	29	29
Migration or Expulsion of Device	28	28
Collapse	26	26
Loss of or Failure to Bond	23	23
Melted	23	23
Packaging Problem	23	23
Device Markings/Labelling Problem	22	22
Difficult or Delayed Separation	22	22
Material Split, Cut or Torn	22	22
Unraveled Material	22	22
Appropriate Term/Code Not Available	20	20
Insufficient Information	19	19
Contamination /Decontamination Problem	19	19
Gas/Air Leak	19	19

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	1899	1899
No Consequences Or Impact To Patient	593	593
Insufficient Information	190	190
No Patient Involvement	151	151
No Known Impact Or Consequence To Patient	116	116
Hemorrhage/Bleeding	69	69
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	58	58
Unspecified Infection	49	49
Thrombosis/Thrombus	36	36
No Information	29	29
Unintended Radiation Exposure	25	25
Foreign Body In Patient	25	25
Blood Loss	25	25
Bacterial Infection	24	24
Air Embolism	22	22
Injury	21	21
Device Embedded In Tissue or Plaque	18	18
Death	14	14
Sepsis	14	14
Cardiac Arrest	13	13
Fever	12	12
Skin Erosion	11	11
Low Blood Pressure/ Hypotension	11	11
Failure of Implant	10	10
Pain	10	10
Exsanguination	10	10
Hematoma	10	10
Swelling/ Edema	9	9
Drug Resistant Bacterial Infection	7	7
No Code Available	7	7
Embolism/Embolus	6	6
Chest Pain	5	5
Purulent Discharge	5	5
Perforation of Vessels	5	5
Loss of consciousness	5	5
Renal Failure	4	4
Shock	4	4
Cardiac Tamponade	4	4
Peritonitis	4	4
Fluid Discharge	3	3
Dyspnea	3	3
Unspecified Tissue Injury	3	3
Tissue Damage	3	3
Respiratory Distress	3	3
Erythema	3	3
Distress	3	3
Abscess	2	2
Stenosis	2	2
Endocarditis	2	2
Swelling	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	Bard Peripheral Vascular Inc	II	Aug-26-2019
4	Covidien LP	II	Apr-24-2024
5	Covidien LP	II	Sep-25-2023
6	Covidien Llc	I	Jul-07-2022
7	Covidien, LP	II	Aug-27-2021
8	MARVAO MEDICAL DEVICES LTD.	II	Jun-01-2021
9	Medical Components, Inc dba MedComp	II	Sep-06-2020